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The hepatitis B elimination is a goal proposed by the WHO to be achieved by 2030 through the adoption of synergistic measures for the prevention and chronic HBV infection treatment. Complete cure is characterized by the HBV elimination from the body and is the goal of the chronic hepatitis B treatment, which once achieved, will enable the hepatitis B elimination. This, today, has been a scientific challenge. The difficulty in achieving a complete cure is due to the indefinite maintenance of a covalently closed episomal circular DNA (cccDNA) reservoir and the maintenance and persistence of an insufficient and dysfunctional immune response in chronically infected patients. Among the measures adopted to eliminate hepatitis B, two have the potential to directly interfere with the virus cycle, but with limited effect on HBV control. These are conventional vaccines-blocking transmission and antiviral therapy-inhibiting replication. Vaccines, despite their effectiveness in protecting against horizontal transmission and preventing mother-to-child vertical transmission, have no effect on chronic infection or potential to eliminate the virus. Treatment with antivirals suppresses viral replication, but has no curative effect, as it has no action against cccDNA. Therapeutic vaccines comprise an additional approach in the chronic infection treatment, however, they have only a modest effect on the immune system, enhancing it temporarily. This manuscript aims to address (1) the cccDNA persistence in the hepatocyte nucleus and the immune response dysfunction in chronically infected individuals as two primary factors that have hampered the treatment and HBV elimination from the human body; (2) the limitations of antiviral therapy and therapeutic vaccines, as strategies to control hepatitis B; and (3) the possibly promising therapeutic approaches for the complete cure and elimination of hepatitis B., (© 2024 Wiley Periodicals LLC.)

Background: Most people diagnosed with chronic hepatitis B (CHB) need treatment to help reduce the risk of liver disease and limit disease transmission. Therapeutic vaccine (TV) candidates have been under study for their clinical effects on inducing HBV-specific host immune responses. This review aimed to systematically synthesize updated evidence on the efficacy and safety of TVs in patients with CHB., Methods: This systematic review was performed by searching different databases from January to February 2021. Completed randomized controlled trials that reported TVs' efficacy and/or safety for treating CHB compared with the standard of care (SOC) or placebo were included. Efficacy and safety estimates were reported as the logarithm of the odds ratio and risk differences, respectively. I2 > 50% was considered significant heterogeneity. Significant publication bias was considered when Egger's test P value < .10. The risk of bias was assessed using the Cochrane Risk of Bias tool. The GRADE methodology was used to assess the certainty of the evidence for each outcome., Results: Twenty-four articles with 2889 pooled samples were included. TVs made a significant difference in hepatitis B envelope antigen (HBeAg) SC (log OR = 0.76, P = .01) and (log OR = 0.40, P = .03) compared to placebo and combination therapy, respectively. HBeAg SC was significantly affected by TVs at the end of follow up (log OR = 0.49, P = .01), with significant HBsAg mean difference (MD = -0.62, P = .00). At the end of treatment, the TVs had no significant effect on HBV DNA negativity over the SOC (log OR = 0.62, P = .09) or placebo (log OR = -0.07, P = .91). TVs do not significantly affect the risk of serious adverse events (RD 0.02, 95% CI 0.00-0.04)., Conclusion: In patients with CHB, TVs had significant effects on HBeAg SC compared to the SOC or placebo. There was no significant difference between serious adverse events. TVs are promising treatment strategy to overcome CHB., Competing Interests: The authors have no funding and conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

These days, fractional calculus is essential for studying the dynamic transmission of illnesses, developing control systems, and solving several other real-world issues. In this study, we develop a Hepatitis B (HBV) model to observe the dynamics of vaccination and treatment effects to control the disease by using novel fractional operator. Modified Atangana-Baleanu-Caputo (MABC) is a new definition of the used derivative that is based on a modification of the Atangana and Baleanu derivatives. By employing the MABC fractional derivative, which incorporates the concepts of non-locality and memory effects our model captures the complex dynamics of HBV transmission more accurately than traditional models. An objective of this study is to analyze the effect of immunization and treatment techniques on the course of the hepatitis B virus, with a particular focus on the changing order of differentiation. Thereby, our paper deals with the stability analysis, positiveness, existence and uniqueness of the solution and simulations. Analysis of reproductive number R0 with the impact of different parameters is also treated. The proposed model's existence and uniqueness findings are examined through the use of Banach's fixed point and Leray-Schauder nonlinear alternative theorems. The equilibria for the models are determined to be globally stable using Lyapunov functions. The simulations for certain parameters are achieved by applying the Lagrange interpolation for the numerical computations and also the results are compared with the ABC operator results. The model is validated using numerical simulations, which are also used to assess how well different intervention techniques work to lower the impact of HBV infection and prevent its spread throughout the community. The results of this research assist in developing public health policies intended to lower the incidence of HBV infection worldwide and offer insightful information about how well treatment and vaccination strategies work to prevent HBV disease., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Zehra et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Hepatitis B virus (HBV) infection is a global public health issue. We offer a comprehensive analysis of the dynamics of HBV, which can be successfully controlled with vaccine and treatment. Hepatitis B virus (HBV) causes a significantly more severe and protracted disease compared to hepatitis A. While it initially presents as an acute disease, in approximately 5 to 10% of cases, it can develop into a chronic disease that causes permanent damage to the liver. The hepatitis B virus can remain active outside the body for at least seven days. If the virus penetrates an individual's body without immunization, it may still result in infection. Upon exposure to HBV, the symptoms often last for a duration ranging from 10 days to 6 months. In this study, we developed a new model for Hepatitis B Virus (HBV) that includes asymptomatic carriers, vaccination, and treatment classes to gain a comprehensive knowledge of HBV dynamics. The basic reproduction number [Formula: see text] is calculated to identify future recurrence. The local and global stabilities of the proposed model are evaluated for values of [Formula: see text] that are both below and above 1. The Lyapunov function is employed to ensure the global stability of the HBV model. Further, the existence and uniqueness of the proposed model are demonstrated. To look at the solution of the proposed model graphically, we used a useful numerical strategy, such as the non-standard finite difference method, to obtain more thorough numerical findings for the parameters that have a significant impact on disease elimination. In addition, the study of treatment class in the population, we may assess the effectiveness of alternative medicines to treat infected populations can be determined. Numerical simulations and graphical representations are employed to illustrate the implications of our theoretical conclusions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Farhan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background & Aims: Mechanisms behind the impaired response of antigen-specific B cells to therapeutic vaccination in chronic hepatitis B virus (HBV) infection remain unclear. The development of vaccines or strategies to overcome this obstacle is vital for advancing the management of chronic hepatitis B., Methods: A mouse model, denominated as E6F6-B, was engineered to feature a knock-in of a B-cell receptor (BCR) that specifically recognizes HBsAg. This model served as a valuable tool for investigating the temporal and spatial dynamics of humoral responses following therapeutic vaccination under continuous antigen exposure. Using a suite of immunological techniques, we elucidated the differentiation trajectory of HBsAg-specific B cells post-therapeutic vaccination in HBV carrier mice., Results: Utilizing the E6F6-B transfer model, we observed a marked decline in antibody-secreting cells 2 weeks after vaccination. A dysfunctional and atypical pre-plasma cell population (BLIMP-1 + IRF4 + CD40 - CD138 - BCMA - ) emerged, manifested by sustained BCR signaling. By deploying an antibody to purge persistent HBsAg, we effectively prompted the therapeutic vaccine to provoke conventional plasma cell differentiation. This resulted in an enhanced anti-HBs antibody response and facilitated HBsAg clearance., Conclusions: Sustained high levels of HBsAg limit the ability of therapeutic hepatitis B vaccines to induce the canonical plasma cell differentiation necessary for anti-HBs antibody production. Employing a strategy combining antibodies with vaccines can surmount this altered humoral response associated with atypical pre-plasma cells, leading to improved therapeutic efficacy in HBV carrier mice., Impact and Implications: Therapeutic vaccines aimed at combatting HBV encounter suboptimal humoral responses in clinical settings, and the mechanisms impeding their effectiveness have remained obscure. Our research, utilizing the innovative E6F6-B mouse transfer model, reveals that the persistence of HBsAg can lead to the emergence of an atypical pre-plasma cell population, which proves to be relevant to the potency of therapeutic HBV vaccines. Targeting the aberrant differentiation process of these atypical pre-plasma cells stands out as a critical strategy to amplify the humoral response elicited by HBV therapeutic vaccines in carrier mouse models. This discovery suggests a compelling avenue for further study in the context of human chronic hepatitis B. Encouragingly, our findings indicate that synergistic therapy combining HBV-specific antibodies with vaccines offers a promising approach that could significantly advance the pursuit of a functional cure for HBV., (Copyright © 2024 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

More than 290 million people worldwide, and almost 2 million people in the United States, are infected with hepatitis B virus, which can lead to chronic hepatitis B, a vaccine-preventable communicable disease. The prevalence of chronic hepatitis B infection in pregnancy is estimated to be 0.7% to 0.9% in the United States, with >25,000 infants born annually at risk for chronic infection due to perinatal transmission. Given the burden of disease associated with chronic hepatitis B infection, recent national guidance has expanded both the indications for screening for hepatitis B infection and immunity and the indications for vaccination. The purpose of this document is to aid clinicians caring for pregnant patients in screening for hepatitis B infection and immunity status, discuss the perinatal risks of hepatitis B infection in pregnancy, determine whether treatment is indicated for maternal or perinatal indications, and recommend hepatitis B vaccination among susceptible patients. The following are the Society for Maternal-Fetal Medicine recommendations: (1) we recommend triple-panel testing (hepatitis B surface antigen screening, antibody to hepatitis B surface antigen, and total antibody to hepatitis B core antigen) at the initial prenatal visit if not previously documented or known to have been performed (GRADE 1C); (2) we recommend universal hepatitis B surface antigen screening alone at the initial prenatal care visit for all pregnancies where there has been a previously documented negative triple-panel test (GRADE 1B); (3) we recommend that individuals with unknown hepatitis B surface antigen screening status be tested on any presentation for care in pregnancy; we also recommend that those with clinical hepatitis or those with risk factors for acute hepatitis B infection be tested at the time of admission to a birthing facility when delivery is anticipated (GRADE 1B); (4) we do not recommend altering routine intrapartum care in individuals chronically infected with hepatitis B; administration of neonatal immunoprophylaxis is standard of care in these situations (GRADE 1B); (5) we do not recommend cesarean delivery for the sole indication of reducing perinatal hepatitis B virus transmission (GRADE 1B); (6) we recommend that individuals with HBV infection can breastfeed as long as the infant has received immunoprophylaxis at birth (GRADE 1C); (7) we suggest individuals with hepatitis B infection who desire invasive testing may have the procedure performed after an informed discussion on risks and benefits in the context of shared decision-making and in the context of how testing will affect clinical care (GRADE 2C); (8) in individuals with hepatitis viral loads >200,000 IU/mL (>5.3 log 10 IU/mL), we recommend antiretroviral therapy with tenofovir (tenofovir alafenamide at 25 mg daily or tenofovir disoproxil fumarate at 300 mg daily) in the third trimester (initiated at 28-32 weeks of gestation) as an adjunctive strategy to immunoprophylaxis to reduce perinatal transmission (GRADE 1B); (9) we recommend administering hepatitis B vaccine and hepatitis B immunoglobin within 12 hours of birth to all newborns of hepatitis B surface antigen-positive pregnant patients or those with unknown or undocumented hepatitis B surface antigen status, regardless of whether antiviral therapy has been given during the pregnancy to the pregnant patient (GRADE 1B); and (10) we recommend hepatitis B vaccination in pregnancy for all individuals without serologic evidence of immunity or documented history of vaccination (GRADE 1C)., (Copyright © 2023. Published by Elsevier Inc.)

Background: Chronic hepatitis-B virus (HBV) infection due to mother-to-child transmission (MTCT) during the perinatal period is an important global health concern. Chile is a low-prevalence country with an increasing migratory inflow from Latin- American countries, with intermediate to high endemic rates of HBV infection, and until 2021, there is no universal maternal screening. This study aimed to evaluate infant outcomes using a risk-based strategy of maternal screening to prevent MTCT of hepatitis B virus (HBV) in a low-prevalence country., Methods: This prospective study included infants born to HBsAg-positive women detected using a local risk-based strategy. The exposed infants received immunoprophylaxis (IP) and follow-up to evaluate their clinical outcomes and immune responses through post-serological vaccine testing (PSVT) after completing the three- dose schedule of the HBV vaccine., Results: A total of 99 HBsAg-positive mothers were detected. Seventy-six (82%) infants completed the follow-up and had PSVT between 9 and 12 months of age. 55.2% female, the median gestational age was 39 weeks (25-41) and the median birth weight was 3,130g (816-4,400 g). All patients received IP with recombinant HBV vaccine plus hepatitis-B virus immunoglobulin (HBIG) and three doses of the HBV vaccine. There were no cases of HBV infection, and 96% (72) responded to immunization with HBsAg antibodies (anti-HBsAg) >10 UI/ml, with a median level of 799 IU/ml., Conclusions: A high-risk strategy can be implemented in countries with non-universal screening for VHB. Timely IP plus high-uptake VHB vaccination in infants born to HBsAg-positive mothers was associated with a high immunogenic response and absence of MTCT., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: The purpose of this study was to investigate immunological variations between a group that received the hepatitis B vaccine and a non-vaccine group. We focused on a cohort that achieved HBsAg seroclearance after Peg-IFNα treatment of CHB., Methods: We enrolled twenty-eight individuals who achieved HBsAg seroclearance after Peg-IFNα treatment. They were divided into two groups: a vaccine group (n = 14) and a non-vaccine group (n = 14). We assessed lymphocyte subpopulations, B cell- and T cell-surface costimulatory/inhibitory factors, cytokines and immunoglobulin levels were detected at different time points to explore immune-function differences between both groups., Results: The seroconversion rate in the vaccine group at 24 weeks post-vaccination was 100%, which was significantly higher (p = 0.006) than that of the non-vaccine group (50%). Additionally, more individuals in the vaccine group exhibited anti-HBs levels exceeding 100 IUs/L and 300 IUs/L compared to the non-vaccine group (p < 0.05). The vaccine group demonstrated significantly increase total B cells and class-switched B cells at 24 weeks and plasma cells, CD80 + B cells, Tfh cells, and ICOS + Tfh cell at 12 weeks, compared with baseline levels (p < 0.05). Conversely, Bregs (CD24 + CD27 + and CD24 + CD38 high ) decreased significantly at 24 weeks (p < 0.05). None of the above changes were statistically significance in the non-vaccine group (p > 0.05). Total IgG increased significantly in the vaccine group, and IL-2, IL-5, and IL-6 concentrations increased significantly at week 24 (p < 0.05). Differences in various types of cytokines and immunoglobulins in the plasma of the non-vaccine group were not significant (p > 0.05). Anti-HBs titers positively correlated with Th1/Th2 cells at 24 weeks (r = 0.448 and 0.458, respectively, p = 0.022 and 0.019, respectively), and negatively with CD24 + CD38 high Breg cells (r = -0.402, p = 0.042)., Conclusions: After achieving HBsAg seroclearance through Peg-IFNα treatment for CHB, administering the hepatitis B vaccine significantly increased anti-HBs-seroconversion rates and antibody levels. We also observed significant immunological differences between the vaccine and non-vaccine groups. Specifically, the vaccine group exhibited significant increases in B cells, plasma cells, and Tfh cells, while Breg levels was significantly lower. These immunological changes are likely conducive to the production of anti-HBs antibodies. However, in the non-vaccine group, the observed changes were not significantlly significant., (© 2024. The Author(s).)

Background: Chronic hepatitis B (HB) remains a significant global health concern, despite the widespread availability of the HB vaccine. While the standard vaccine demonstrates an impressive serological response rate exceeding 90%, a subset of individuals exhibit suboptimal immunity. This study aims to elucidate the efficacy of the AS04C-adjuvanted HB vaccine in addressing non-responsiveness., Methods: Conducted at the Preventive Medicine Service of the University Albacete Hospital in Spain from 2017 to 2021, this single-center observational study enrolled 195 patients. Among them, 126 (65%) were classified as non-responders following one or two complete standard vaccination courses., Results: After the administration of a complete four-dose regimen of the AS04C-adjuvanted vaccine, 73.81% of non-responder patients exhibited antibody titers indicative of robust immunity (anti-HBs >10)., Conclusions: These findings underscore the pivotal role of the AS04C-adjuvanted HB vaccine in addressing non-responsiveness, emphasizing its potential as a crucial tool in augmenting immunization strategies for various populations. This includes non-responders to standard vaccination, individuals with chronic kidney disease, those requiring seroprotection due to factors like immunosuppression or occupational hazards, as well as patients for whom conventional revaccination strategies have proven futile. Additional research is needed to expand on the promising results obtained through our protocol., (© The Author(s) 2023. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.)

Vaccines are widely regarded as one of the most effective weapons in the fight against infectious diseases. Currently, vaccines must be stored and transported at low temperatures as high temperatures can lead to a loss of vaccine conformation and reduced therapeutic efficacy. Metal-organic frameworks (MOFs), such as zeolitic imidazole framework-8 (ZIF-8), are a new class of hybrid materials with large specific surface areas, high loading rates, and good biocompatibility and are successful systems for vaccine delivery and protection. Silk fibroin (SF) has a good biocompatibility and thermal stability. In this study, the hepatitis B surface antigen (HBsAg) was successfully encapsulated in ZIF-8 to form HBsAg@ZIF-8 (HZ) using a one-step shake and one-pot shake method. Subsequently, the SF coating modifies HZ through hydrophobic interactions to form HBsAg/SF@ZIF-8 (HSZ), which enhanced the thermal stability and immunogenicity of HBsAg. Compared to free HBsAg, HZ and HSZ improved the thermostability of HBsAg, promoted the antigen uptake and lysosomal escape, stimulated dendritic cell maturation and cytokine secretion, formed an antigen reservoir to promote antibody production, and activated CD4 + T and CD8 + T cells to enhance memory T-cell production. Importantly, HSZ induced a strong immune response even after 14 days of storage at 25 °C. Furthermore, the nanoparticles prepared by the one-step shake method exhibited superior properties compared to those prepared by the one-pot shake method. This study highlights the importance of SF-coated ZIF-8, which holds promise for investigating thermostable vaccines and breaking the vaccine cold chain.

Background: While mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains a significant challenge in China, research investigating the effectiveness of the September 2017 pilot program to eliminate MTCT of HIV, syphilis, and HBV is limited. Baoan district, which has a higher-than-average rate of hepatitis B infection among pregnant women and strong support from the government, was one of six national pilot districts selected for the program. Therefore, this study aims to assess the progress and implementation of the elimination of MTCT of HBV in Baoan district over a period of 5 years., Methods: Data was collected from the national information system for the prevention of MTCT, registration forms, and follow-up forms of pregnant women and their live births from 2018 to 2022. Joinpoint models were used to analyze changing trends over time, calculating annual percentage change (APC) and the corresponding 95% confidence interval (95%CI). Multivariate logistic regression models were used to analyze risk factors for HBV MTCT., Results: From 2018 to 2022, the coverage of HBV screening during pregnancy increased from 98.29 to 99.55% (APC = 0.30, P = 0.012). The coverage of HBV early screening within 13 gestational weeks increased from 40.76 to 86.42% (APC = 18.88, P = 0.033). The prevalence of maternal HBV infection declined by an APC of - 3.50 (95% CI -6.28 ~ - 0.63). The coverage of antiviral therapy among high-risk pregnant women increased from 63.59 to 90.04% (APC = 11.90, P = 0.031). Coverage for timely administration of hepatitis B immunoglobulin, hepatitis B birth dose vaccine, and three-dose hepatitis B vaccination remained consistently above 97.50%. The coverage of post-vaccination serological testing (PVST) in high-risk infants was 56.15% (1352/2408), and the MTCT rate of HBV was 0.18%. Mothers with high-school education or below (OR = 3.76, 95% CI 1.04 ~ 13.60, P = 0.04) and hepatitis B e antigen (HBeAg) positivity (OR = 18.89, 95% CI 1.98 ~ 18.50, P = 0.01) had increased MTCT risk., Conclusions: The implementation of comprehensive prevention strategies in Baoan district, including screening, treatment, and immunoprophylaxis, has proven effective in maintaining the MTCT of HBV at an extremely low level. However, it remains crucial to raise public awareness, specifically on the importance of improving the coverage of PVST for infants exposed to HBV., (© 2023. The Author(s).)

Background & Aims: Immunotherapy for chronic hepatitis B virus (HBV) infection has not yet demonstrated sufficient efficacy. We developed a non-integrative lentiviral-vectored therapeutic vaccine for chronic hepatitis B and tested its antiviral effects in HBV-persistent mice and two inactive HBsAg carriers., Methods: Lentiviral vectors (LVs) encoding the core, preS1, or large HBsAg (LHBs) proteins of HBV were evaluated for immunogenicity in HBV-naïve mice and therapeutic efficacy in a murine model of chronic HBV infection. In addition, two inactive HBsAg carriers each received two doses of 5×10 7 transduction units (TU) or 1×10 8 TU of lentiviral-vectored LHBs (LV-LHBs), respectively. The endpoints were safety, LHBs-specific T-cell responses, and serum HBsAg levels during a 24-week follow-up., Results: In the mouse models, LV-LHBs was the most promising in eliciting robust antigen-specific T cells and in reducing the levels of serum HBsAg and viral load. By the end of the 34-week observation period, six out of ten (60%) HBV-persistent mice vaccinated with LV-LHBs achieved serum HBsAg loss and significant depletion of HBV-positive hepatocytes in the liver. In the two inactive HBsAg carriers, vaccination with LV-LHBs induced a considerable increase in the number of peripheral LHBs-specific T cells in one patient, and a weak but detectable response in the other, accompanied by a sustained reduction of HBsAg (-0.31 log 10 IU/ml and -0.46 log 10 IU/ml, respectively) from baseline to nadir., Conclusions: A lentiviral-vectored therapeutic vaccine for chronic HBV infection demonstrated the potential to improve HBV-specific T-cell responses and deplete HBV-positive hepatocytes, leading to a sustained loss or reduction of serum HBsAg., Impact and Implications: Chronic HBV infection is characterized by an extremely low number and profound hypo-responsiveness of HBV-specific T cells. Therapeutic vaccines are designed to improve HBV-specific T-cell responses. We show that immunization with a lentiviral-vectored therapeutic HBV vaccine was able to expand HBV-specific T cells in vivo, leading to reductions of HBV-positive hepatocytes and serum HBsAg., (Copyright © 2023 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Despite the outstanding progress that has been made in the prevention, detection, and management of hepatitis B during the past decades, hepatitis B remains a problem among healthcare personnel (HCP) in many countries. We reviewed studies on all aspects of hepatitis B in HCP published from 2017 through April 2023. They revealed wide variations on the prevalence of infection among HCP, ranging from 0.6% in Europe to >8.7% in Africa, almost always in association with very low vaccination rates. Many studies found a significant association between HCP's knowledge about hepatitis B and hepatitis B vaccines, their vaccination status, and practices. This research also discloses global inequities regarding vaccination policies against hepatitis B, free-of-charge vaccinations, and access to post-exposure prophylaxis (PEP). Strategies to prevent and manage accidental exposures are needed in order to reduce the burden of hepatitis B on HCP, while written policies for all aspects of infection prevention, protective equipment, and PEP should be available. Lastly, HCP should be accordingly educated. These are all imperative given the decline of routine vaccinations in the COVID-19 era, particularly in countries with fragile vaccination programs, and the disruptions of interventions for hepatitis B that are expected to provide a pool of virus transmission to future generations.

Background: Hepatitis B virus (HBV) vaccine reduced the incidence of Hepatitis B worldwide. Genetic variability, by the presence of specific haplotypes of HLA system (HLA-DR3, HLA-DR4), influences the response to the vaccination. Subjects affected by type 1 diabetes (T1D), contrary to non-diabetics, have a high prevalence of Hepatitis B., Methods: The objective of the study was to evaluate anti-HBs antigen (anti-HBsAg) antibody (Ab) in a group of 201 children (age range: 2-18 years), regularly vaccinated against HBV according to the national vaccination schedule. Patients with anti-HBs Ab≥10 mIU/mL have been defined "responders" and those with anti-HBs Ab<10mIU/mL have been defined "non-responders." The possible association between the T1D and a low immune response to the vaccine has been subsequently valued. Besides the presence of T1D, other possible influential variables have been studied: sex, age, presence of celiac disease and Hashimoto's thyroiditis, intervening years from the diagnosis of diabetes and presence/absence of diabetic ketoacidosis at time of diagnosis., Results: Among the 201 subjects with T1D, 90 (44.8%) were responders, while 111 (55.2%) were non-responders; among the 145 subjects without T1D, 86 (59.3%) were responders and 59 (40.7%) non-responders. We invited "Subjects with T1D non-responders" to undergo a booster dose of the same vaccine. Of these, 21 refused the booster, reducing the sample to 90 patients. After 4 weeks from the booster dose 81 patients showed seroconversion ("false non-responders"), and 9 did not ("true non-responders")., Conclusions: After the booster dose, immune response in our cross-section has been similar to general population. Given the high frequency of "false non-responders" anti-HBsAg Ab should be tested in T1D patients and a booster dose should be administrated in non-responders.

Aluminium adjuvants are commonly used in vaccines to stimulate the immune system, but they have limited ability to promote cellular immunity which is necessary for clearing viral infections like hepatitis B. Current adjuvants that do promote cellular immunity often have undesired side effects due to the immunostimulants they contain. In this study, a hybrid polymer lipid nanoparticle (HPLNP) was developed as an efficient adjuvant for the hepatitis B surface antigen (HBsAg) virus-like particle (VLP) vaccine to potentiate both humoral and cellular immunity. The HPLNP is composed of FDA approved polyethylene glycol-b-poly (L-lactic acid) (PEG-PLLA) polymer and cationic lipid 1, 2-dioleoyl-3-trimethylammonium-propane (DOTAP), and can be easily prepared by a one-step method. The cationic optimised vaccine formulation HBsAg/HPLNP (w/w = 1/600) can maximise the cell uptake of the antigen due to the electrostatic adsorption between the vaccine nanoparticle and the cell membrane of antigen-presenting cells. The HPLNP prolonged the retention of the antigen at the injection site and enhanced the lymph node drainage of antigen, resulting in a higher concentration of serum anti-HBsAg IgG compared to the HBsAg group or the HBsAg/Al group after the boost immunisation in mice. The HPLNP also promoted a strong Th1-driven immune response, as demonstrated by the significantly improved IgG2a/IgG1 ratio, increased production of IFN-γ, and activation of CD4 + and CD8 + T cells in the spleen and lymph nodes. Importantly, the HPLNP demonstrated no systemic toxicity during immunisation. The advantages of the HPLNP, including good biocompatibility, easy preparation, low cost, and its ability to enhance both humoral and cellular immune responses, suggest its suitability as an efficient adjuvant for protein-based vaccines such as HBsAg-VLP. These findings highlight the promising potential of the HPLNP as an HBV vaccine adjuvant, offering an alternative to aluminium adjuvants currently used in vaccines., (© 2023. The Author(s).)

Hepatitis B viral infection is a significant source of morbidity and mortality worldwide. The United States has experienced a precipitous drop in acute hepatitis B infection after the introduction and widespread adoption of recombinant vaccines. Neonates experience significant risk from both vertical and horizontal hepatitis B exposure during a period of immaturity of the innate and adaptive immune systems. Acquisition of hepatitis B virus at or near birth confers the highest lifetime risk of chronic infection and subsequent complications including liver cirrhosis and hepatocellular carcinoma. Pregnant women should be screened for the presence of hepatitis B surface antigen, indicating acute or chronic infection, and, if positive, hepatitis B viral deoxyribonucleic acid, allowing for quantification of viral load. The development of highly effective and safe recombinant vaccines allows partial protection of late preterm and term neonates immediately after birth. Additionally, administration of hepatitis B immune globulin in the setting of suspected or confirmed exposure supplements the immune response and decreases the risk of chronic infection. The optimal timing of vaccination is later in low-birth-weight neonates due to the aforementioned immune system immaturity. Health care providers serving neonates must familiarize themselves with national guidelines regarding hepatitis B vaccination and hepatitis B immune globulin therapy. Understanding the risks of infection and the evidence basis supporting vaccination and immunotherapy will allow providers to educate families and support decision-making, with the potential to eradicate this vaccine-preventable illness in our lifetime., (© Copyright 2023 Springer Publishing Company, LLC.)

Background: The 2016 World Health Assembly endorsed the elimination of hepatitis B virus (HBV) infection as a public health threat by 2030; existing therapies and prophylaxis measures make such elimination feasible, even in the absence of a virological cure. We aimed to estimate the national, regional, and global prevalence of HBV in the general population and among children aged 5 years and younger, as well as the rates of diagnosis, treatment, prophylaxis, and the future burden globally., Methods: In this modelling study, we used a Delphi process with data from literature reviews and interviews with country experts to quantify the prevalence, diagnosis, treatment, and prevention measures for HBV infection. The PRoGReSs Model, a dynamic Markov model, was used to estimate the country, regional, and global prevalence of HBV infection in 2022, and the effects of treatment and prevention on disease burden. The future incidence of morbidity and mortality in the absence of additional interventions was also estimated at the global level., Findings: We developed models for 170 countries which resulted in an estimated global prevalence of HBV infection in 2022 of 3·2% (95% uncertainty interval 2·7-4·0), corresponding to 257·5 million (216·6-316·4) individuals positive for HBsAg. Of these individuals, 36·0 million were diagnosed, and only 6·8 million of the estimated 83·3 million eligible for treatment were on treatment. The prevalence among children aged 5 years or younger was estimated to be 0·7% (0·6-1·0), corresponding to 5·6 million (4·5-7·8) children with HBV infection. Based on the most recent data, 85% of infants received three-dose HBV vaccination before 1 year of age, 46% had received a timely birth dose of vaccine, and 14% received hepatitis B immunoglobulin along with the full vaccination regimen. 3% of mothers with a high HBV viral load received antiviral treatment to reduce mother-to-child transmission., Interpretation: As 2030 approaches, the elimination targets remain out of reach for many countries under the current frameworks. Although prevention measures have had the most success, there is a need to increase these efforts and to increase diagnosis and treatment to work towards the elimination goals., Funding: John C Martin Foundation, Gilead Sciences, and EndHep2030., Competing Interests: Declaration of interests S Blach, C Estes, D M Razavi-Shearer, E Mooneyhan, I Gamkrelidze, K Razavi-Shearer, A Voeller, and H A Razavi are employees of the Center for Disease Analysis Foundation. The Center for Disease Analysis Foundation has received funding from the John C Martin Foundation, ZeShan Foundation, The Hepatitis Fund, Gilead Sciences, and AbbVie. A Aghemo reports grants or contracts from Gilead Sciences, Janssen Pharmaceuticals, & AbbVie; consulting fees from Gilead Sciences and AbbVie; and support for attending meetings and/or travel from Gilead Sciences and AbbVie. S Aleman reports payment or honoraria for lectures and educational events from Gilead, AbbVie, Merck Sharp & Dohme, Biogen, not related to this work. M Anderson reports grants and contracts from British Medical Foundation Trust Institution, ANTRUK Institution, Dunhill Medical Trust Institution, and Pfizer Institution; consulting fees from Prenetics, and serving the E3 initiative. T Asselah reports honorariums from consulting for Gilead Sciences, Antios therapeutics, Eiger Biopharmaceutical, Janssen, GlaxoSmithKline, and Vir Biotechnology; support for attending meetings and/or travel from Gilead Sciences and AbbVie, and advisory board of ENYO. T Berg reports grants or contracts from AbbVie, Bristol Myers Squibb, Gilead, Merck Sharp & Dohme, Humedics, Intercept, Merz, Norgine, Novartis, Orphalan, Sequana Medical; consulting fees from AbbVie, Alexion, Bayer, Gilead, GlaxoSmithKline, Eisai, Enyo Pharma, HepaRegeniX GmbH, Humedics, Intercept, Ipsen, Janssen, Merck Sharp & Dohme, Novartis, Orphalan, Roche, Sequana Medical, SIRTEX, SOBI, and Shionogi; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AbbVie, Alexion, Bayer, Gilead, Eisai, Falk Foundation, Intercept, Ipsen, Janssen, MedUpdate GmbH, Merck Sharp & Dohme, Novartis, Orphalan, Sequana Medica, SIRTEX, and SOBI; and support for attending meetings and/or travel from Gilead, AbbVie, Intercept, Janssen. C Brosgart reports being a Member, Board of Directors of the Hepatitis B Foundation as well as the Member of the Board of Directors of the following biotech companies: Abivax, Galmed, Enochian, Eradivir, Merlin, and stock options in the following companies: Abivax, Galmed, Enochian, Eradivir, Merlinx. KA Brown reports research grants for clinical trials within their institution from Salix & Eurofins; honorariums for lectures from Salix, Intercept, Gilead, Madrigal; data safety monitoring board for AstraZeneca Proxymo-Advance-Cooperative Studies Program v 3.0, Advisory boards Gilead, Intercept, Salix, Alexion; Secretary of Chronic Liver Disease Foundation and Incoming Chair AASLD Foundation Board. RS Brown reports institutional grants and consulting fees from Gilead and AbbVie. P Bruggman reports research grant from Gilead, speaker fees from Gilead and AbbVie, travel grants from Gilead and AbbVie, and serving as the Swiss Hepatitis Chair Hepatitis C Association & Board member Swiss Association for the Medical Management in Substance Users. MR Brunetto reports consulting fees from Gilead, honoraria for presentations from AbbVie, Gilead, and Eisai-MSD; travel support from AbbVie & Gilead; participation in advisory boards for Roche, Janssen, AbbVie, Eisai-MSD, & Gilead; and Coordinator of the working group for the implementation of the resolution (n.397, April 2018) for hepatitis C virus (HCV) infection control in Tuscany, Italy. M Buti reports consulting fees and honoraria for presentations from Gilead, Janssen & Altoinmune. HLY Chan reports consulting fees from AbbVie, Aligos, Arbutus, Hepion, GlaxoSmithKline, Janssen, Merck, Roche, Vir Biotech, Vaccitach, Virion Th, & Gilead; honoraria for presentations from Gilead, Viatris, & Roche; and travel support to academic conferences from Gilead and AbbVie. J Cabezas reports grants, consulting fees, payment for lectures, support for meetings including travel, and participation on advisory boards from Gilead and AbbVie. He also serves on the boards for AEEH – Spanish Association for the Study of the Liver and the INHSU Prison Network. PJ Chen reports grants and contracts from Ministry of Education Taiwan, National Science and Technology Council Taiwan. KJ Cheng reports grants and contracts from Philippine Department of Health and the Philippine Council of Health Research and Development. H Chenquier reports honoraria for lectures and support for meetings including travel from Gilead. WL Chuang reports consulting fees from Gilead, AbbVie, Bristol Myers Squibb and PharmaEssentia. V Chulanov reports payment for lectures and presentations from AbbVie, Merck Sharp & Dohme, Gilead, and R-Pharm. C Coffin reports grants and contracts paid to the University of Calgary by Gilead Sciences, Janssen Pharmaceuticals; consulting fees paid to the University of Calgary by Roche Pharmaceuticals, and Altimmune Pharmaceuticals; lecture honorarium from Gilead Sciences; holds International Patent PCT/CA2021/050234 Polypeptides directed against viral infection and uses thereof US Patent 17/425,791.Polypeptides directed against viral infection and uses thereof; advisory board membership for Gilead Sciences; President-Elect of Canadian Association for the Study of the Liver; and research materials from Gilead Sciences. M Cornberg reports consulting fees from AbbVie, Gilead, Merck Sharp & Dohme advisory boards, GlaxoSmithKline, Janssen-Cilag, Spring Banks PharmaceuticalsAdvisory Boards; payment for lectures from AbbVie, Gilead, Merck Sharp & Dohme, Falk; travel support from AbbVie; Advisory board member for Novartis; and German Liver Foundation Scientific Secretary European Association for the Study of The Liver Governing Board 2018, 2019, 2020. BC Cowie reports Australian Government Public sector research grants related to viral hepatitis State Government of Victoria, Australia – Department of Health Public sector research grants related to viral hepatitis EndHEP2030/The Hepatitis Fund Competitive philanthropic/not-for-profit research grant related to viral hepatitis and World Health Organization Support for travel to attend WHO workshops and committee meetings related to viral hepatitis Royal Melbourne Hospital Support for travel to attend meetings for continuing medical education related to viral hepatitis. ME Cramp reports Liberum Independent Medical Education payment for role in helping develop and deliver an on-line educational program on HCV and its treatment for health care professionals. A Craxi reports consulting fees and honoraria for lectures from AbbVie, Gilead Sciences and Merck Sharp & Dohme. J Crespo reports research support from Gilead Sciences, AbbVie, Merck Sharp & Dohme and Intercept Pharmaceuticals; consulting fees from Gilead, AbbVie, Intercept, Shionogui; speaker for Gilead Sciences, Rubio, Intercept, Amgen and AbbVie; travel support from Gilead and AbbVie; serving as the president of Spanish Society of Duel Pathology; and receipt of materials from Echosens. R de Kneght reports grants or contracts from GlaxoSmithKline, Jassen Cilag, Inventiva, and Echosens; consulting fees from Echosens and Gilead; and payment or honoraria from AbbVie and Echosens. V de Ledinghen reports grants, consulting fees, speaker honorariums, and travel support from Gilead & AbbVie. G Dore reports research grants from AbbVie, Gilead Sciences, and Merck. S Drazilova reports payment or honoraria from AbbVie and Gilead; support for attending meetings and/or travel from AbbVie and Gilead; and advisory board participation for AbbVie and Gilead. AS Duberg reports payment for speaking from Gilead and Merck Sharp & Dohme. M El-Kassas reports research grants from AstraZeneca, Roche, Merck Sharp & Dohme, AbbVie, Gilead, Janssen, Intercept, Rameda, Ipsen, Onxeo, Bayer, Oncoustics, PDC; payment for lectures from Eva, Mash Premier, Takeda, Organon, AUG Pharma, Inspire, HSO Pharma, MinaPharm, Pharco, Zeta, Alfa Cure, and, Spimaco; advisory board of PDC Pharma; and serving on boards of International Association for the Study of the Liver, Africa Hepatopancreatobiliary Cancer Consortium, and EARTH. M El Sayed reports honorariums from Gilead Sciences for podcast speaker, Abbott as a World Hepatitis Day speaker and Biotest speaker for HBV Preventon of Mother to Child Transmission; and received travel award for EASL 2019. O Etzion reports consulting fees from Eiger Biopharmaceuticals; speaker honoraria from Gilead, AbbVie, Neopharm; travel support from AbbVie; advisory board of HepQuant; and serving as Secretary, Israeli Society for the study if liver diseases. R Flisiak reports grants and consulting fees from AbbVie, Pfizer, Gilead, and Merck Sharp & Dohme; honoraria for speaking from AbbVie, Gilead, and Pfizer; travel support from AbbVie and Gilead; and advisory board of AbbVie, Pfizer, Gilead, and Merck Sharp & Dohme. X Forns reports grants or contracts from Instituto Carlos III, Ministerio Sanidad, España; consulting fees from Affirma and Gilead; speaker fees from Gilead; and participation on an advisory board for Novaratis. S Frankova reports consulting fees from Gilead & AbbVie; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Gilead, AbbVie, Merck and AOP Orphan; Support for attending meetings and/or travel from Gilead & AbbVie; and participation on a data safety monitoring board or advisory board from AOP Orphan and Sobi. E Gane reports personal speaking fees from Scientific Advisory Board Gilead, Scientific Advisory Board AbbVie, and Scientific Advisory Board Janssen as well as serving on advisory boards for Aligos, Janssen, and Assembly. J García-Samaniego reports consulting fees and speaker honoraria from Gilead Sciences. P Gholam reports speaking and consulting honoraria from Gilead Sciences. R Gish reports grants/research support from Gilead; Consultant and/or Advisor to Abbott, AbbVie, Altimunne, Antios, Arrowhead, Dynavax, Eiger, Eisai, Enyo, Genentech, Genlantis, Gerson Lehrman Group, Gilead Sciences, Helios, HepaTX, HepQuant, Intercept,Janssen, Merck, Pfizer, Topography Health, Venatorx; Current Activity with Scientific or Clinical Advisory Boards: AbbVie, Dynavax, Enyo, Genentech, Genlantis, Gilead, Helios, HepaTX, HepQuant, Intercept, Janssen, Merck, Pfizer, Prodigy; Chair Clinical Advisory Board: Prodigy; Advisory Consultant: Diagnostic Companies: Fibronostics, Fujifilm/Wako, Perspectum, Quest, Sonic Incytes; and Data Safety Monitoring Board: Arrowhead, CymaBay Therapeutics, Durect. M Gottfredsson reports honoraria for speaking from Gilead Sciences and participation on Nordic Advisory Board for COVID-19 with Gilead Sciences. J Grebly reports grants from AbbVie, Camurus, Cepheid, Gilead Sciences, Hologic, & Indivior; honoraria for lectures from AbbVie, Cepheid, and Gilead Sciences; serves as president of International Network on Health and Hepatitis in Substance Users; and received equipment for HCV testing platforms from Cepheid and HCV tests from Hologic. M Gschwantler received grants from AbbVie, Gilead, and Merck Sharp & Dohme; speaking honoraria/advisory board fees from AbbVie, Gilead, Merck Sharp & Dohme, Janssen, Bristol Myers Squibb, Roche, Intercept, Alnylam, Norgine, AstraZeneca, Falk, Gebro Pharma and Shionogi. S Hamid reports participating on the advisory board for the Sofosbuvir plus Ravidasvir Trial. M Hellard reports investigator initiated research grants from Gilead Sciences and AbbVie. YC Hsu reports grants and contracts from Taiwan's National Science and Technology Council, Gilead Sciences, E-Da Hospital, Stanford University, and Tomorrow Medical Foundation; honoraria for speaking from Gilead Sciences, Roche, AbbVie, & Bristol Myers Squibb; travel support from AbbVie and Gilead Sciences; and advisory board participation for Gilead Sciences. P Jarcuska reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, support for attending meetings and travel and advisory board participation for AbbVie and Gilead. J Jaroszewicz reports consulting fees, honoraria for speaking, travel support and participation on advisory boards for AbbVie and Gilead. D Jelev reports clinical trial contracts with Hoffmann La Roche and GlaxoSmithKline and travel support for International Liver Congress 2022 and 2023 from Angelini Pharma. A Jeruma reports speaker honoraria from AbbVie and Merck Sharp & Dohme; and travel support from AbbVie, Merck Sharp & Dohme, and Gilead. M Kaberg reports a Gilead Fellowship 2020 that was paid to their institution and speaker honoraria from Nordic Drugs, Gilead, and Merck Sharp & Dohme. L Kondili reports consulting fees from AbbVie; speaking honoraria and support for travel from AbbVie and Gilead Sciences. P Kristian reports honoraria for lectures from AbbVie and Gilead Sciences Slovakia. P Lampertico reports honoraria for speaking from Bristol Myers Squibb, Roche, Gilead Sciences, GlaxoSmithKline, AbbVie, Merck Sharp & Dohme, Arrowhead, Alnylam, Janssen, Sbring Bank, MYR, Eiger, Antios, and Aligos. D Lavanchy reports serving on the Swiss Hepatitis Strategy and Viral Hepatitis Prevention Board. JV Lazarus reports grants from AbbVie, Gilead Sciences and Merck Sharp & Dohme to their institution; consulting fees from AbbVie and Gilead Sciences; honoraria for speaking from AbbVie, Gilead Sciences, Intercept, Janssen, Merck Sharp & Dohme, Novo Nordisk; advisory board participation for AbbVie; and serving the EASL International Liver Foundation as Vice-chair, HIV Outcomes Co-chair, EuroTest Steering Committee member, all unpaid. RT Marinho reports consulting fees, travel support and participation on advisory boards for AbbVie, Gilead, and Bayer. S Merat reports travel support from and stock options with RojanPharma Co. C Moreno reports grants from Gilead; honoraria for lectures from Gilead, Astellas, Intercept and Bayer; and travel support from and advisory board participation with Gilead and AbbVie. L Mortgat reports the ECDC covering the costs of The 7th Hepatitis B and C Network meeting in Stockholm. B Müllhaupt reports grants from Gilead and the Swiss National Science Foundation; consulting fees from Alexion, AbbVie, Gilead, Bristol Myers Squibb, Roche, Intercept, Triogen, & Astra Zeneca; honoraria for lectures from Gilead, Roche, Astra Zeneca, and AbbVie; travel support from Gilead, and serves as the co-president of the Swiss Society of Gastroenterology. F Negro reports consulting fees from Gilead & AbbVie (60% institution and 40% personal); honoraria for lectures from Gilead, Roche, & AbbVie (60% institution and 40% personal); travel support from AbbVie and Gilead; and serving on the advisory board of Genfit with all payments going to their institution. Q Ning reports consulting fees from Giles, Merck Sharp & Dohme, Novartis, Bristol Myers Squibb, Roche & GlaxoSmithKline. C Osiowy reports support from American Association for the Study of the Liver: Invited speaker at the North American Viral Hepatitis Elimination Summit, March 24–25, 2023, Reimbursement payment made to Govt. of Canada; International Plasma and Fractionation Association (IPFA): Invited speaker at the IPFA/Paul Ehrlich Institute 29th International Workshop on Surveillance and Screening of Blood-borne Pathogens, May 10–11, 2023, Reimbursement payment made to Govt. of Canada. CQ Pan reports research grants and honoraria for lectures from Gilead Sciences paid to their institution. G Papatheodorids reports grants or contracts from Gilead; consulting fees from AbbVie, Albireo, Elpen, Genesis, Gilead, GlaxoSmithKline, Janssen, Ipsen, Merck Sharp & Dohme, Novo Nordisk, Roche, Takeda; payment or honoraria from AbbVie, Elpen, Gilead, GlaxoSmithKline, Janssen, Ipsen, Merck Sharp & Dohme, Novo Nordisk, Roche; and support for attending meetings and/or travel from AbbVie, Elpen, Gilead, Janssen and Ipsen. M Peck-Radosavljevic reports consulting fees from AbbVie and Gilead Sciences; honoraria for lectures from AbbVie, Gilead Sciences, and Merck Sharp & Dohme; and travel support from AbbVie and Gilead Sciences. L del Rocio Pincay Rodriguez reports support from the Ministry of Public Health of Ecuador & the National Subsecretariat for Health Surveillance, Prevention and Control; consulting fees from the Pan American Health Organization; and travel support from the Ministry of Public Health Ecuador. A Ramji reports grants from AbbVie, Gilead, Intercept, Merck; consulting fees from AbbVie, Gilead, Intercept; honoraria for lectures from AbbVie, Gilead, Intercept, Amgen, Novo-Nordisc, Novartis; participation in advisory boards for AbbVie, Gilead, Intercept, Janssen, Novo-Nordisc, Novartis; and stock options with AbbVie. LR Roberts reports support from National Cancer Institute, NIH P50 CA 210964 Hepatobiliary Cancer SPORE; research grants to the Mayo Clinic from Bayer, Boston Scientific, Exact Sciences, Fujifilm Medical Systems, Gilead Sciences, Glycotest, Inc, Redhill Biopharma, TARGET PharmaSolutions; participation in advisory boards with all payments made to the Mayo Clinic of Astra Zeneca, Bayer, Eisai, Exact Sciences, Gilead Sciences, QED, TAVEC; and serves pro bono on the Hepatitis B Foundation, Africa Partners Medical, West Africa Institute for Liver and Digestive Disease Foundation. SK Roberts reports honoraria for lectures from Gilead for the Honoraria Steering Committee for Symposium and Eisai for HCC lecture presentation; and participates on the HCC advisory board for AstraZeneca. M Rodriguez reports consulting fees and support for meetings and travel from Gilead, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AbbVie and Gilead. MD Roulot reports travel support from Gilead. O Sagalova reports payment for presentations from Gilead, AbbVie, Merck Sharp & Dohme, Pharmstandart. R Salupere reports honoraria for educational events and travel support from Takeda Pharma, AbbVie, Merck Sharp and Dohme; participation in advisory board for Arena Pharmaceuticals; and serves as a member of the Estonian Society of Gastroenterology. C Sarrazin reports honoraria for lectures for Gilead and Bristol Meyers Squibb; payments for advisory boards from Gilead; and unpaid board member of the German Society of Internal Medicin (DGIM), the German Patient Association Deutsche Leberhilfe, and the German Liver Association Deutsche Leberstiftung. WK Seto reports research grants paid to their institution from Gilead, Pfizer, Alexion Pharmaceutical, Ribo Life Sciences, Boehringer Ingelheim; consulting fees from Gilead & Abbot; and honoraria for lectures from Gilead, AstraZeneca, Abbott. D Shouval reports consulting fees from VBI Vaccines Inc, and advisory board member of the Viral Hepatitis Prevention Board, Belgium. K Simojoki reports payment or honoraria for lectures from AbbVie and Gilead; support for attending meetings and/or travel from AbbVie; and serving on the Hepatitis + HIV expert board 2020–2023 for the National Institute of Health. MJ Sonneveld reports grants from Gilead Sciences and Fujirebio; consulting fees from Gilead Sciences and Albireo; and receipt of materials from Fujirebio. CW Spearman reports honoraria for a presentation from Gilead Sciences and Roche Diagnostics. J Sperl reports grants from Gilead Sciences; consulting fees from Gilead Sciences, AbbVie, and Merck Sharp Dohme; honoraria for lectures from Gilead Sciences, AOP Orphan, AbbVie, Herbacos Recordati, Merck Sharp Dohm; travel support from Gilead Sciences, AbbVie, and AOP Orphan; and participation on advisory boards for AOP Orphan, Swedish Orphan Biovitrum, and Alnylam. RE Strauber reports honoraria for lecture from AbbVie; a travel grant from AbbVie; and being on the advisory boards of Bristol Myers Squibb, Lilly, Roche, Gilead. CS Steadman reports honoraria for a podcast from AbbVie; advisory board for AbbVie; and member of the executive board of the New Zealand Society of Gastroenterology. V Sypsa reports grants and contracts as well as participation on a data safety monitoring board or advisory board from Gilead paid to her affiliated institution. F Tacke reports grants paid to their institution from Allergan, Bristol Myers Squibb, Inventiva, Gilead; consulting fees from Allergan, Bayer, Gilead, Bristol Myers Squibb, Boehringer, Intercept, Ionis, Inventiva, Merz, Pfizer, Alnylam, NGM, CSL Behring, Novo Nordisk, Novartis; honoraria for lectures from Gilead, AbbVie, Falk, Merz, Intercept; payment for expert testimony from Alnylam; travel support from Gilead; and advisory board for Pfizer. N Terrault reports grants from Gilead, Genentech, Roche; consulting fees from EXIGO Mgnt LLC, ENYO, PPD Pharma; and honoraria for speaking from the University of Maryland. P Thompson reports grants from National Institutes of Health NIAID K08AI148607, Doris Duke Foundation Cinical Scientist Development Award #2022057, Merck, and principal investigator for Vielot; travel support for NIAID PRID Review Committee; and regents provided by Abbott laboratories and research support from Gilead Sciences for DRC HBV studies outside of the current work. I Tolmane reports honoraria for speaking from AbbVie, Merck Sharp & Dohme, Roche, Swedish Orphan Biovitrum, Gilead and travel support from AbbVie and Merck Sharp & Dohme. K Tomasiewicz reports grants from AbbVie, Gilead, and Promed; consulting fees from AbbVie, Gilead, Promed, Merck; honoraria for speaking from AbbVie, Gilead, and Promed, Merck, Astra Zeneca, and Alfasigma; travel support from AbbVie and Gilead; advisory boards for AbbVie, Gilead and Alfasigma. T Vanwolleghem reports grants from Gilead Sciences, Janssen Pharmaceuticals, and AbbVie; consulting fees and travel support from AbbVie and Gilead Sciences. A Vince reports honoraria for lectures and online events from AbbVie, Gilead, Merck Sharp & Dohme; and serving on the Drug Committee of Croatian Health Insurance Fund. N Weis reports unrestricted research grants from AbbVie and Gilead; consulting fees from AbbVie; honoraria for lecturing from AbbVie, GlaxoSmithKline, Gilead and Merck Sharp & Dohme; advisory board of AbbVie, Gilead, GlaxoSmithKline, Merck Sharp & Dohme, and Novo Nordisk; travel support from AbbVie, Gilead, GlaxoSmithKline and Merck Sharp & Dohme. GLH Wong reports grants from Gilead Sciences; consulting fees from Gilead Sciences and Janssen, and honoraria for speaking from Abbott, AbbVie, Bristol-Myers Squibb, Echosens, Furui, Gilead Sciences and Roche. VWS Wong reports grants paid to their institution from Gilead Sciences; consulting fees from 3V-BIO, AbbVie, Allergan, Boehringer Ingelheim, Echosens, Gilead Sciences, Inventiva, Merck, Novartis, Novo Nordisk, Pfizer, ProSciento, Sagimet Biosciences, TARGET PharmaSolutions, Terns; travel support to their institution from Gilead Sciences and AbbVie; honoraria for speaking from Abbott, AbbVie, Echosens, Gilead Sciences, Novo Nordisk; serving pro bono as a Member of the Steering Committee on Prevention and Control of Viral Hepatitis, Council Member of the Hong Kong Association for the Study of Liver Diseases; and cofounder of Illuminatio Medical Technology Limited. TCF Yip reports consulting fees, honoraria for speaking and travel support from Gilead Sciences. ML Yu reports grants from Abbott, AbbVie, Bristol Myers Squibb, Gilead, Merck and Roche diagnostics; consulting fees from AbbVie, Abbott, Bristol Myers Squibb, Gilead, Merck, PharmaEssentia, Roche and Roche diagnostics; honoraria for speaking from AbbVie, Abbott, Bristol Myers Squibb, Eisai, Eli Lilly, Gilead, IPSEN, Merck, Ono, Roche and Roche diagnostics; travel support from AbbVie, Abbott, Gilead, and Roche diagnostics; and serving on Taiwan Association for the Study of the Liver. C Yudaydin reports consulting fees paid to their institution from Gilead; honoraria for speaking from Roche Biopharma, Eiger Biopharma, and Gilead; travel support to institution from AbbVie and Gilead; and unpaid advisory board for Eiger Biopharma., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: Hepatitis B is a potentially fatal liver infection caused by the hepatitis B virus (HBV). It is a serious issue for global health. It considerably raises the risk of cirrhosis and liver cancer-related death and can result in chronic infection. The risk of infection is high among health sciences students due to the risk of occupational contact with fluids of infected patients and the risk of needle stick injury. The most effective way of preventing HBV infection is the vaccination of students prior to their posting to healthcare settings. There is no data available about HBV vaccination uptake among Health Sciences students in Somalia. Therefore, this study aimed to determine HBV vaccination uptake and associated factors toward HBV among health science students in Somalia., Methods: A cross-sectional study was undertaken among health sciences students from August to October 2022. Data were gathered using Kobo Toolbox using a standardized questionnaire with questions on characteristics, knowledge attitude, and HBV prevention practices. A total of 569 students were involved in the study. Stata version 15 was utilized for the analysis. Bivariate and multivariate logistic regression analysis, as well as descriptive statistics, were performed. In order to assess the existence and significance of the relationship between the outcome and risk factors, an adjusted odds ratio with a 95% confidence interval (CI) was used. Statistical significance was considered as a p -value ≤0.05., Results: Of the 569 study participants, 33.4% (95%CI: 29.6-37.4) received a full dose of the HBV vaccine in this study. Participants had good HBV prevention knowledge, attitudes, and practices at 69.6, 37.96, and 50.6%, respectively. The lack of access and the high cost of the vaccine were the reasons for not taking the vaccine. Second-year [AOR: 0.22 (0.12-0.43)]. Positive attitude [AOR: 0.54 (0.31-0.93)], and good practice [AOR: 6.99 (3.62-13.5)]., Discussion: The study indicated that 33.4% of health sciences students had received the required HBV vaccination doses, academic year, attitude, and practice were significantly associated with full-dose vaccination status. The unavailability of the vaccine and the high cost of vaccination were the most common reasons for not taking the vaccine. It is recommended that students receive vaccinations before beginning clinical rotations, and give instruction on infection prevention strategies and general precautions, particularly regarding HBV infection., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Hassan, Hassan and Ahmed.)

Background: Hepatitis B vaccination is recommended for all children at birth within 24 hours or during childhood., Objective: This study was aimed to evaluate protective efficacy of hepatitis B vaccine and estimate the sero-prevalence of hepatitis B virus infection among vaccinated children., Materials and Methods: A community-based cross-sectional study was conducted from March, 2021 to October, 2021 in Debre Markos town. A simple random sampling technique was used to select 165 fully vaccinated children aged 5-12 years old. A serum sample was used to determine hepatitis B surface antigen (HBsAg), anti-hepatitis B core antibody (anti-HBc), anti-hepatitis B surface antibody titer (anti-HBs) using ELISA., Results: The seroprevalence of HBsAg and anti-HBc anti-body was found to be 4.2% and 4.8% respectively. Of 165 fully vaccinated children, 129 (78.2%) had anti-HBs titer ≥ 10 mIU/ml. Among 129 sero-protected children, 76 (58.9%) were hypo-responders whereas the rest 53 (41.1%) were good responders. Those children within the age group of 5-7 years were 2.9 times (AOR: 2.873, 95% CI: 1.156, 7.141) (P<0.023) more likely to respond to HBV vaccine. Multivariate logistic regression revealed that children who were born from HBV positive mothers (AOR 3.917, 95% CI: 1.456, 5.365, P<0.027) and those who had history of injectable medications (AOR 9.232, 95% CI: 1.503, 11.697, P<0.016) were more likely to be HBsAg positive. Children who had history of hospital admission (AOR 6.973, 95% CI: 1.495, 8.530, P<0.013) were more likely to be anti-HBcAb positive., Conclusions: There was an intermediate prevalence of childhood HBV infection despite being vaccinated suggesting low protective efficacy of hepatitis B vaccine in the study area., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Adugna et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: In 2020, WHO recommended the addition of peripartum antiviral prophylaxis (PAP) to hepatitis B birth dose vaccination (HepB-BD) and hepatitis B infant vaccination (HepB3) to reduce mother-to-child transmission of hepatitis B virus (HBV) infection in pregnant women who have a marker of high infectivity (ie, HBV DNA ≥200 000 international units per mL or HBeAg-positive). We aimed to evaluate the impact and cost-effectiveness of this recommendation and of a theoretical simplified strategy whereby PAP is given to all pregnant women who are HBsAg-positive without risk stratification., Methods: This modelling study used a dynamic simulation model of the HBV epidemic in 110 countries in all WHO regions, structured by age, sex, and country. We assessed three strategies of scaling up PAP for pregnant women: PAP for those with high viral load (PAP-VL); PAP for those who are HBeAg-positive (PAP-HBeAg); and PAP for all pregnant women who are HBsAg-positive (PAP-universal), in comparison with neonatal vaccination alone (HepB-BD). We investigated how different diagnostic and antiviral drug costs affected the cost-effectiveness of the strategies evaluated. Using a health-care provider perspective, we calculated incremental cost-effectiveness ratios in cost (US$) per disability-adjusted life-year (DALY) averted in each country's population and compared these with country-specific cost-effectiveness thresholds. We also calculated new neonatal infections averted for each of the strategies., Findings: Adding PAP-VL to HepB-BD could avert around 1·1 million (95% uncertainty interval 1·0 million-1·2 million) new neonatal infections by 2030 and around 3·2 million (95% uncertainty interval 3·0 million-3·4 million) new neonatal infections and approximately 8·8 million (7·8 million-9·7 million) DALYs by 2100 across all the countries modelled. This strategy would probably be cost-effective up to 2100 in 28 (26%) of 106 countries analysed (which included some of the countries that have the greatest HBV burden) if costs are as currently expected to be, and in 74 (70%) countries if diagnostic and monitoring costs were lowered (by about 60-75%). The relative cost-effectiveness of PAP-VL and PAP-HBeAg was finely balanced and depended on the respective diagnostic and monitoring costs. The PAP-universal strategy could be more cost-effective than either of these strategies in most countries, but the use of antiviral treatment could be five times as high than with PAP-VL., Interpretation: PAP can provide substantial health benefits, and, although the current approach might already be cost-effective in some high-burden settings, decreased diagnostic costs would probably be needed for PAP to be cost-effective in most countries. Therefore, careful consideration needs to be given about how such a strategy is implemented, and securing reduced costs for diagnostics should be a priority. The theoretical strategy of offering PAP to all women who are HBsAg-positive (eg, if diagnostic tests to identify mothers at risk of transmission are not available) could be a cost-effective alternative, depending on prevailing costs of diagnostics and antiviral therapy., Funding: UK Medical Research Council, UK National Institute for Health and Care Research, and the Vaccine Impact Modelling Consortium., Competing Interests: Declaration of interests SN reports grants to their institution not connected to this work from Gavi, the Vaccine Alliance. YS reports grants to their institution not connected to this work from Gilead Sciences, and equipment to their other projects from Abbott Laboratories and Fujirebio. ML reports grants to their institution not connected to this work from the UK Medical Research Council (MRC), the French National Agency for Research on AIDS, Cepheid UK, and Gilead Sciences USA; consultancy fees from Gilead Sciences USA; and equipment to their other projects from Abbott USA. TBH reports grants to their institution not connected to this work from Gavi. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background and Rationale: Chronic HCV infection induces lasting effects on the immune system despite viral clearance. It is unclear whether certain immune alterations are associated with vaccine responses in cured HCV patients., Approach: Thirteen cured HCV patients received the standard 3-dose hepatitis B vaccine and were followed up at the 0, 1st, 6th, and 7th months (M0, M1, M6, and M7) after the first dose of vaccination. Thirty-three-color and 26-color spectral flow cytometry panels were used for high-dimensional immunophenotyping of the T-cell and B-cell subsets, respectively., Results: Compared to the healthy controls (HC), 17 of 43 (39.5%) immune cell subsets showed abnormal frequencies in cured HCV patients. Patients with cured HCV were further divided into high responders (HR, n = 6) and nonresponders (NR1, n = 7) based on the levels of hepatitis B surface antibodies at M1. Alterations in cell populations were more significant in NR1. Moreover, we found that high levels of self-reactive immune signatures, including Tregs, TD/CD8, IgD-only memory B, and autoantibodies, were associated with suboptimal hepatitis B vaccine responses., Conclusions: Our data suggest that cured HCV patients exhibit persistent perturbations in the adaptive immune system, among which highly self-reactive immune signatures may contribute to a suboptimal hepatitis B vaccine response., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Association for the Study of Liver Diseases.)

Objective: Elimination programs and interventions for patients with viral hepatitis B (HBV) have been disrupted during the COVID-19 pandemic. This study aimed to evaluate the effects of the COVID-19 pandemic on patients with HBV infection in terms of COVID-19 vaccine preferences, follow-up visits, and antiviral treatment compliance., Patients and Methods: In this retrospective single-center cross-sectional study, 129 patients with viral hepatitis B infection were evaluated. The patients were surveyed at the time of admission. A special form was created for patients with viral hepatitis B infection, and the form contained information about the patients at admission to collect the study data., Results: A total of 129 participants were included in the study. Of the participants, 49.6% were males and the median age was 50 years. In total, 73 (56.6%) patients had their follow-up visits disrupted because of the COVID-19 pandemic. No newly diagnosed case of HBV infection was detected. Among the 129 patients, 46 had inactive hepatitis B, and 83 had chronic hepatitis B infection and were receiving antiviral treatment. None of the patients had trouble reaching antiviral treatments during the COVID-19 pandemic. A liver biopsy was recommended for 8 patients. Half of these 8 patients did not have follow-up visits during the COVID-19 pandemic. Most of the patients (123/129, 95.3%) received the COVID-19 vaccine and the most frequent vaccine that was used was the Pfizer-BioNTech (n: 92, 71.3%) vaccine. Serious side effects of the COVID-19 vaccines were not detected. Mild side effects were found in 41.9% (13/31) of the patients. The COVID antibody level was found to be statistically and significantly higher in the patients who received the Pfizer-BioNTech vaccine than in those that received the CoronoVac vaccine., Conclusions: It was reported that elimination programs and interventions for HBV infection decreased or stopped because of the COVID-19 pandemic. In the present study, no newly diagnosed case of HBV infection was detected. Most of the patients had their follow-up visits disrupted. There were no patients who could not receive antiviral treatment, the vaccination rate of the patients was high, and the vaccines were well tolerated.

Immunoprophylaxis has not completely eliminated hepatitis B virus (HBV) infection due to hyporesponsiveness to hepatitis B vaccine (HepB). We explored the impact of folic acid supplementation (FAS) in pregnant women with positive hepatitis B surface antigen (HBsAg) on their infant hepatitis B surface antibody (anti-HBs) and the mediation effect of infant interleukin-4 (IL-4). We recruited HBsAg-positive mothers and their neonates at baseline. Maternal FAS was obtained via a questionnaire, and neonatal anti-HBs and IL-4 were detected. Follow-up was performed at 11-13 months of age of infants, when anti-HBs and IL-4 were measured. We applied univariate and multivariate analyses. A mediation effect model was performed to explore the mediating role of IL-4. A total of 399 mother-neonate pairs were enrolled and 195 mother-infant pairs were eligible for this analysis. The infant anti-HBs geometric mean concentrations in the maternal FAS group were significnatly higher than those in the no-FAS group (383·8 mIU/ml, 95 % CI: 294·2 mIU/ml to 500·7 mIU/ml v . 217·0 mIU/ml, 95 % CI: 147·0 mIU/ml to 320·4 mIU/ml, z = -3·2, P = 0·001). Infants born to women who took folic acid (FA) within the first trimester were more likely to have high anti-HBs titres (adjusted β -value = 194·1, P = 0·003). The fold change in IL-4 from neonates to infants partially mediated the beneficial influence of maternal FAS on infant anti-HBs (24·7 % mediation effect) after adjusting for confounding factors. FAS during the first trimester to HBsAg-positive mothers could facilitate higher anti-HBs levels in infants aged 11-13 months partly by upregulating IL-4 in infants.

Background: Hepatitis B is a viral infection that has a high prevalence in Indonesia. The Ministry of Health of Indonesia has conducted a national vaccination program for hepatitis B. In order to evaluate the success of the hepatitis B vaccination in Indonesia, a community study based on basic health research (Riskesdas) was performed nationwide since 2007 for five year period in 2007, 2013, and 2018., Methods: Further statistical analysis was performed specifically for the children under 59 months old (toddlers) immunized in both urban and rural areas in 2007, 2013, and 2018 based on certain characteristics by examining antibodies against HBsAg (anti-HBs), IgG antibodies against the core antigen (HBcAb), surface antigen (HBsAg) of hepatitis B virus (HBV). The data obtained from the data management laboratory of Ministry of Health, Indonesia, was analyzed with Bivariate analysis with continuity correction chi-square or Pearson chi-square using Stata software version 16., Results: This study showed an increase in hepatitis B coverage of complete immunization (30% in 2007, 60.3% in 2013, and 57% in 2018), which was also influenced by mothers' level of education (Pearson chi-square , p ¡ 0.05 ) and access to health service points within 30 minutes (OR = 1.3-2.8, p ¡ 0.05 ). The trend of the percentage of immune status (anti-HBs) was increased (41.8% in 2007; 56.1% in 2013; and 79.1% in 2018). The higher anti-HBs was found in complete hepatitis B immunization status (OR = 1.5-2, p ¡ 0.05 ) and in good nutritional status ( p ¡ 0.05 ). However, the anti-HBs was found decreased with increasing age ( p ¡ 0.05 ). The trend of positive HBcAb (exposure to HBV infection) showed a decrease gradually of almost ten times from 2007 (8.6%-13.5%) compared to 2013 (2.6%-11.1%) and 2018 (1.1%-2%). Urban areas were at higher risk of hepatitis B exposure (OR = 1.4-2.2) than rural areas (OR = 0.37-0.80). The HBsAg data were only available in 2013 and 2018. Riskesdas data analysis showed the prevalence of hepatitis B (HBsAg) was lower in complete immunization status than that in incomplete one ( p ¡ 0.05 ), but with an increase from 3.9% (2013) to 9.3% (2018), possibly due to inappropriate implementation of birth dose immunization or a vaccine-escape mutant from the HBV variants., Conclusions: The effectiveness of hepatitis B vaccine obtained from the three Riskesdas periods in Indonesia showed an improvement, with an increase in immune status, reduced exposure to HBV and a lower prevalence of hepatitis B in children with complete vaccination. However, there is still an increase in hepatitis B infection, especially in urban areas. Therefore, a long-term evaluation of immunization coverage especially ensuring that the initial dose of immunization was given within the first 24 h of birth, HBsAg and HBcAb, nutritional status, genomic surveillance of HBV, and other aspects of program quality evaluation are needed to ensure that elimination efforts have been implemented properly., Competing Interests: The authors declare there are no competing interests., (©2023 Lestari et al.)

Background: Various vaccine adjuvants have been developed to eliminate HBV from patients with chronic HBV infection. In addition, spermidine (SPD), a type of polyamine, has been reported to enhance the activity of immune cells. In the present study, we investigated whether the combination of SPD and vaccine adjuvant enhances the HBV antigen-specific immune response to HBV vaccination. Methods: Wild-type and HBV-transgenic (HBV-Tg) mice were vaccinated 2 or 3 times. SPD was orally administered in drinking water. Cyclic guanosine monophosphate-AMP (cGAMP) and nanoparticulate CpG-ODN (K3-SPG) were used as the HBV vaccine adjuvants. The HBV antigen-specific immune response was evaluated by measuring the HBsAb titer in blood collected over time and the number of interferon-γ producing cells by enzyme-linked immunospot assay. Results: The administration of HBsAg + cGAMP + SPD or HBsAg + K3-SPG + SPD significantly enhanced HBsAg-specific interferon-γ production by CD8 T cells from wild-type and HBV-Tg mice. The administration of HBsAg, cGAMP, and SPD increased serum HBsAb levels in wild-type and HBV-Tg mice. In HBV-Tg mice, the administration of SPD + cGAMP or SPD + K3-SPG with HBV vaccination significantly reduced HBsAg levels in the liver and serum., Conclusions: These results indicate that the combination of HBV vaccine adjuvant and SPD induces a stronger humoral and cellular immune response through T-cell activation. These treatments may support the development of a strategy to completely eliminate HBV., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Association for the Study of Liver Diseases.)

Background: This study aimed to evaluate loss of protective anti-hepatitis B (HBs) titers and seroconversion to hepatitis B vaccine (HBV) during chemotherapy in children with acute lymphoblastic leukemia (ALL)., Methods: Anti-HBs titers were done at diagnosis. Patients were divided into two groups. Group I (protective titers >10 mIU/ml) received single double dose of HBV as booster. Titers were repeated at three time points: end of phase 1b, beginning of re-induction, and start of maintenance chemotherapy. Group II (nonprotective titers <10 mIU/L) received hepatitis B immunoglobulin (HBIG), prior to start of chemotherapy, followed by three double doses of HBV as booster. Titers were repeated at two time points: prior to first dose, and 4 weeks after third dose of vaccine., Results: Total 125 patients were included: 88 in group I; 37 in group II. Among group I patients, 98.7%, 90%, and 84% retained protective titers at the three points, respectively. Subgroup analysis showed that those with initial titers greater than 100 mIU/L retained protective titers better than those with titers between 11 and 100 mIU/L (p = .0001). Among group II patients, 62% and 64% attained protective titers at the two points, respectively., Conclusions: HBV boosters helped maintain protective titers during intensive ALL chemotherapy in immunized children having titers more than 10 mIU/L, and more so if titer was more than 100 mIU/L. Therefore, we propose that cut off for protective anti-HBs titers be changed to greater than or equal to 100 mIU/L. Titers between 11 and 100 mIU/L may require combined active and passive immunization. Around one-third of group II patients who fail to attain protective titers may need frequent doses of HBIG., (© 2022 Wiley Periodicals LLC.)

Context: The aim of neonatal pain management is to reduce pain and help the baby cope with pain., Objective: This study aimed to determine the effect of Helfer skin tap technique (HSTT) on hepatitis B vaccine intramuscular (IM) injection pain in neonetes., Design: Randomized controlled study SETTING: This study was conducted with neonatal infants born vaginally in the delivery room of a state hospital in Turkey., Participants: This study was conducted total 60 neonates including 30 in the HSTT group and 30 in the Routine Technique (RT) group., Interventions: Participants were randomized into the HSTT group and the Routine Technique (RT) group., Main Outcome Measures: Data were collected using a questionnaire form and the Neonatal Infant Pain Scale (NIPS)., Results: While the means of the total pain scores in the HSTT group were found to be 1.73 ± 2.04 during injection and 1.73 ± 0.98 after injection, in the RT group, the mean scores were 5.56 ± 0.92 during injection and 4.90 ± 1.25 after injection. The difference between the groups arising in the comparison of means of the total pain scores obtained during and after injection in HSTT and RT groups was determined to be statistically significant (p <0.05)., Conclusion: In conclusion, HSTT was proven to be effective in reducing hepatitis B vaccine intramuscular (IM) injection pain in neonates. This study demonstrates that HSTT is associated with reduced pain in newborns during hepatitis B vaccine IM injections., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Vaccination against hepatitis B virus (HBV) is recommended for dialysis patients. Two reports comparing seroprotection (SP) rates following HepB and HepB-CpG in vaccine-naïve patients with chronic kidney disease enrolled few dialysis patients (n = 122 combined). SP rates in a subset of dialysis patients were not reported or not powered to detect statistically significant differences. SP rates in those requiring additional vaccine series or booster doses are not known., Methods: A retrospective cohort analysis including dialysis patients completing HepB or HepB-CpG vaccination between January 2019 and December 2020. Vaccine-naïve patients received a series of HepB or HepB-CpG (Series 1). A repeat series was given to nonresponders (Series 2). A booster regimen consists of one dose of either vaccine. Primary outcome was achieving SP (anti-HBs >10 mIU/mL) at least 60 days after the last HBV vaccine dose for Series 1 and Series 2, and achieving SP at least 3 weeks post-booster., Results: For Series 1 (n = 3509), SP after HepB vaccination was significantly higher (62.9% versus 50.1% for HepB-CpG; P < 0.0001). Series 2 (n = 1040) and booster (n = 2028) SP rates were similar between vaccines. Patients that received up to four HepB-CpG doses had higher SP rates compared with four doses of HepB (82.0% versus 62.9%, respectively; P < 0.0001)., Conclusions: SP rates in hepatitis B vaccine-naïve dialysis patients administered a recommended four doses of HepB were higher than those recommended two doses of HepB-CpG. SP rates were higher and achieved sooner if HepB-CpG was utilized initially and, if needed, for Series 2. Optimal HepB-CpG dosing deserves further study., (© The Author(s) 2022. Published by Oxford University Press on behalf of the ERA.)

There is currently no known cure for hepatitis B virus (HBV) infection, and HBV remains a major public health burden in the United States. The US Department of Health and Human Services has established a Viral Hepatitis National Strategic Plan with the goal of eliminating HBV infection in the United States by the year 2030. This goal will be achieved by reducing the incidence of new HBV infections by 90% and mortality by 65%, with a main focus on prevention of HBV infection through vaccination. Currently, 4 HBV vaccines (excluding bivalent vaccines) are available in the United States for use in adults, including Heplisav-B, which was approved by the FDA in November 2017 for use in adults 18 years and older. All 4 HBV vaccines are equally recommended as options for the prevention of HBV infection by the Advisory Committee on Immunization Practices. This article provides an overview of emerging considerations based on CDC recommendations and new clinical data around HBV vaccines, as well as the potential of Heplisav-B in fulfilling unmet needs that currently exist in the HBV prevention landscape.

Background: Strategies recommended to decrease the risk of infection associated with the use of multiple sclerosis disease-modifying treatments include screening and immunization against common viral infections such as varicella-zoster (VZV) and hepatitis B (HBV). However, the data concerning the durability of those vaccine responses and the need for re-test is scarce., Objectives: We aimed to evaluate HBV and VZV seroprotection loss in MS patients under DMT., Methods: We conducted a cohort study including patients with basal seroprotective titers against HBV/VZV viruses and a subsequent serology performed at least 3 months apart. We evaluated predictors of seroprotection loss through a binary regression., Results: HBV seroprotection loss occurred in one-fifth of patients in a median interval of 21.3 months. Anti-CD20 treatment (OR 8.559 95%CI 3.467- 21.130, p < 000.1), age at last serology higher or equal to 55 years (OR 7.506, 95% CI 2.473-22.786, p < 0.001) and basal HBsAb titer (OR 0.992, 95%CI 0.987 -0.996, p=0.001) increase the risk of seroprotection loss. VZV seroprotection loss occurred rarely in a median interval of 21.3 months. We could not identify any factor associated with an increased risk of VZV seroprotection loss., Conclusions: Anti-CD20 drugs are associated with a loss of seroprotection against HBV in a short-interval follow-up., Competing Interests: Declaration of Competing Interest The authors report no conflicts of interest., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Introduction: A hepatitis B vaccination (HepB) series with an initial dose of hepatitis B immune globulin (HBIG) is the recommended prophylaxis for infants born to mothers with chronic hepatitis B virus (HBV) infection and for HBV-exposed persons without known protection. The HepB and HBIG are administered at different sites (limbs). Instances of HepB and HBIG administered at the same site are documented but the impact on immune responses to HepB remains unanswered., Methods: Newborn and adult BALB/c mice received one dose of HepB at time zero alone or with HBIG in the same or different sites, followed by 2 additional doses of HepB at 3 and 10 weeks (newborn mice) or 4 and 16 weeks (adult mice). To study memory responses mice were given a 4th, booster, dose of HepB at 26 weeks and B cells analyzed., Results: Administration of HepB with HBIG resulted in reduced responses to HepB following the first 2 doses, regardless of site, compared to mice that received HepB only. Lower levels of antibody to HBV surface antigen (anti-HBs) were observed at the end of the 3-dose series (p < 0.0001) in all groups of newborn mice that received HepB and HBIG. In adult mice, this difference was only seen when HepB and HBIG were delivered at the same site. However, following a HepB booster at 26 weeks, HBsAg-specific B-cell expansion and memory phenotype were not impacted by initial HBIG administration CONCLUSION: Administration of HBIG with HepB can delay and reduce responses to HepB in mice. Our findings suggest that the initial circulating levels of HBIG could prevent infection despite an impaired response to vaccine and support the current recommendation of assessing seroprotection after series completion for infants born to HBV carrier mothers, including in cases where vaccine and HBIG are administered incorrectly at the same site., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)

Although the current hepatitis B (HB) vaccine comprising yeast-derived small hepatitis B surface antigen (HBsAg) is potent and safe and used worldwide, specific concerns should not be ignored, such as the attenuated prophylaxis against hepatitis B virus (HBV) infection with specific amino acid polymorphisms, called vaccine-escape mutations (VEMs). We investigated a novel HB vaccine consisting of large-HBsAg that covers the shortcomings of the current HB vaccine in a nonhuman primate model. The yeast-derived large-HBsAg was mixed with the adjuvant and used to immunize rhesus macaques, and the induction of antibodies to HBsAg was compared with that of the current HB vaccine. The current HB vaccine predominantly induced antibodies to small-HBsAg, whereas immunization with the large-HBsAg vaccine mainly induced antibodies to the preS1 region. Although the antibodies induced by the current HB vaccine could not prevent infection of HBV with VEMs, the large-HBsAg vaccine-induced antibodies neutralized infection of HBV with VEMs at levels similar to those of the wild type. The HBV genotypes that exhibited attenuated neutralization by induced antibodies differed between these vaccines. In conclusion, the novel HB vaccine consisting of large-HBsAg was revealed to be useful to compensate for shortcomings of the current HB vaccine. The combined use of these HB vaccines may be able to induce antibodies that can neutralize HBV strains with VEMs or multiple HBV genotypes.

Hepatitis B virus (HBV) infection is a main challenge of the health system worldwide. Health policymakers in most countries attempt to help HBV patients by implementing support programs in addition to controlling HBV in their community so that the economic burden caused by HBV do not deprive the patients of accessing health services and reducing their quality of life. There are several health interventions for the prevention and control of HBV. Providing the first dose of the HBV vaccine within 24 hours after the infant is born is the most cost-effective way to prevent and control HBV. The purpose of this study is to review the nature of HBV, its epidemiology in Iran and worldwide, and to review the various policies and programs in Iran regarding the prevention and control of HBV, especially the use of vaccination. One of the goals of Sustainable Development Goals (SDGs) is to consider hepatitis as a threat to human health. In this regard, one of the top priorities of WHO is the prevention and control of HBV. In connection with the prevention of HBV, it is claimed that vaccination is the most effective and best intervention. Thus, vaccination in the safe's program of countries is highly recommended. According to the Ministry of Health and Medical Education (MOHME) reports, Iran has the lowest prevalence of HBV among the countries in Eastern Mediterranean Region Organization (EMRO). There is a hepatitis unit in MOHME whose responsibility is to coordinate and implement the hepatitis prevention and control programs. The HBV vaccine has been officially included in the vaccination program for children in Iran since 1993, and three doses of the vaccine are given to all infants. In 2007, during a large-scale program in Iran, 17-year-olds received the HBV vaccine, followed by adolescents born in 1990 and 1991. In recent years, the health system in Iran has made significant progress in preventing and controlling HBV. Over 95% coverage of the HBV vaccination is one of the achievements that have had a great impact on reducing the trend of HBV infection. In order to achieve the 2030 goals, the Iranian government, in addition to paying more attention to HBV elimination programs, should encourage other organizations to cooperate more effectively with MOHME., (©2022 Pacini Editore SRL, Pisa, Italy.)

Objectives: Eliminating mother-to-child transmission (MTCT) of hepatitis B virus (HBV) is central to WHO's target of reducing hepatitis B infection in children to &lt;0.1% by 2030. While Nigeria accounts for 8.3% of the global burden, interventional studies on prevention of MTCT of HBV are hardly available. This study aimed to assess the impact of prevention of MTCT interventions on vertical transmission of HBV among pregnant women in Nigeria., Design: A prospective cohort study., Setting: A University Teaching Hospitals Complex in Nigeria between 2015 and 2021., Participants: 10 866 pregnant women and their pre-existing children., Interventions: Eligible pregnant women were screened for HBsAg using chromatographic immunoassay (Micropoint, USA). HbsAg-positive women had HBV serological assay done and their pre-existing children were screened. Women with HBV DNA ≥2 00 000 IU/mL and those positive for hepatitis B e-antigen (HBeAg) had 300 mg/day of Tenofovir Disoproxil Fumarate (TDF) in the third trimester. The newborns had hepatitis B vaccines and HB immunoglobulin (HBIG) administered, followed by testing for HBsAg at 9 months postnatally., Primary Outcome Measures: Prevalence of chronic hepatitis B infection in pregnancy, and the incidence of MTCT of HBV., Results: Overall, 395 women had chronic HBV infection, giving a prevalence of 3.64%. Their mean age was 31.51±5.71 years, with a median parity of 1.2. Thirteen women (5.2%) were positive for HBeAg, seven (3.1%) of the 225 pre-existing hepatitis B-exposed children were HbsAg positive and 17 women had prenatal TDF. Overall, 376 women completed the study, with mean birth weight of 3.21±1.86 kg and perinatal mortality rate of 29.2/1000 births. Hepatitis Bvaccine-HBIG combination was administered to 260 newborns, while the others had hepatitis B vaccine alone. All the children tested negative to the HbsAg at 9 months., Conclusion: Eliminating MTCT of HBV infection through validated protocols in low and middle income countries with the highest burden of chronic HBV infections is feasible. National scale-up of such protocols is recommended., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: To evaluate the protective efficacy of a hepatitis B (HB) vaccination program in Taiwan among high-risk children., Methods: Children born to HBeAg-positive mothers from 2001 to 2010 were invited back. Blood samples for hepatitis B virus (HBV) seromarkers were taken and the children underwent hepatobiliary ultrasonography. Perinatal factors including delivery mode and vaccination history were collected from their medical records. According to the results of HBV serological markers, the children were initially classified into five groups: HBV naïve, HB vaccine responder, HBsAg carrier, recovered from HBV infection, and anti-HBc-positive alone. Children in the HBV naïve and anti-HBc-positive alone groups who presented with an anamnestic response after a booster HB vaccine were re-assigned to the vaccine responder and recovered from infection groups, respectively., Results: All of the 196 enrolled children received postnatal hepatitis B immunoglobulin (HBIG) and HB vaccinations, of whom one was HBV naïve (0.5%), 109 were vaccine responders (55.6%), 21 were carriers (10.7%), and 65 recovered from infection (33.2%). Among the 21 carriers, 14 (66.7%) presented in the immunotolerant phase. Cesarean section was the only significant perinatal factor between the carriers (5.3%) and those who recovered from infection (37.7%) (p = 0.007)., Conclusion: In this study, there was a 43.9% HBV infection rate and 10.7% HBsAg carrier rate in high-risk Taiwanese children even after receiving HBIG and HB vaccinations. C-section may protect newborns from becoming HBsAg carriers, while HBV genotype and time of HBIG injection did not contribute to the HBV carrier rate., Competing Interests: Conflicts of interest All authors have no conflicts of interest that could be perceived to bias their work, making known all financial support and any other personal connections., (Copyright © 2021 Chang Gung University. Published by Elsevier B.V. All rights reserved.)

Background: Hepatitis B is the leading cause of cirrhosis and liver cancer in sub-Saharan Africa. To reduce mortality, antiviral treatment programs are needed. We estimated prevalence, vaccine impact, and need for antiviral treatment in Blantyre, Malawi., Methods: We conducted a household study in 2016-2018. We selected individuals from a census using random sampling and estimated age-sex-standardized hepatitis B surface antigen (HBsAg) seroprevalence. Impact of infant hepatitis B vaccination was estimated by binomial log-linear regression comparing individuals born before and after vaccine implementation. In HBsAg-positive adults, eligibility for antiviral therapy was assessed., Results: Of 97386 censused individuals, 6073 (median age 18 years; 56.7% female) were sampled. HBsAg seroprevalence was 5.1% (95% confidence interval [CI], 4.3%-6.1%) among adults and 0.3% (95% CI, .1%-.6%) among children born after vaccine introduction. Estimated vaccine impact was 95.8% (95% CI, 70.3%-99.4%). Of HBsAg-positive adults, 26% were HIV-positive. Among HIV-negative individuals, 3%, 6%, and 9% were eligible for hepatitis B treatment by WHO, European, and American hepatology association criteria, respectively., Conclusions: Infant HBV vaccination has been highly effective in reducing HBsAg prevalence in urban Malawi. Up to 9% of HBsAg-positive HIV-negative adults are eligible, but have an unmet need, for antiviral therapy., Competing Interests: Potential conflicts of interest. N. B.-Z. reports grants from Merck-Sharp-Dohme, Johnson & Johnson, and Serum Institute of India, outside the submitted work. A. M. G. reports grants and personal fees from Roche Pharma Research and Early Development, ViiV Healthcare, and Gilead; personal fees from Janssen; and consulting fees from GSK, outside the submitted work. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.)

Although the current hepatitis B (HB) vaccine comprising small-HBs antigen (Ag) is potent and safe, attenuated prophylaxis against hepatitis B virus (HBV) with vaccine-escape mutations (VEMs) has been reported. We investigate an HB vaccine consisting of large-HBsAg that overcomes the shortcomings of the current HB vaccine. Yeast-derived large-HBsAg is immunized into rhesus macaques, and the neutralizing activities of the induced antibodies are compared with those of the current HB vaccine. Although the antibodies induced by the current HB vaccine cannot prevent HBV infection with VEMs, the large-HBsAg vaccine-induced antibodies neutralize those infections. The HBV genotypes that exhibited attenuated neutralization via these vaccines are different. Here, we show that the HB vaccine consisting of large-HBsAg is useful to compensate for the shortcomings of the current HB vaccine. The combined use of these HB vaccines may induce antibodies that can neutralize HBV strains with VEMs or multiple HBV genotypes., (© 2022. The Author(s).)

Despite being vaccine-preventable, hepatitis B virus (HBV) infection remains the seventh leading cause of mortality in the world. In South Africa (SA), over 1.9 million people are chronically infected with HBV, and 70% of all Black chronic carriers are infected with HBV subgenotype A1. The virus remains a significant burden on public health in SA despite the introduction of an infant immunization program implemented in 1995 and the availability of effective treatment for chronic HBV infection. In addition, the high prevalence of HIV infection amplifies HBV replication, predisposes patients to chronicity, and complicates management of the infection. HBV research has made significant progress leading to better understanding of HBV epidemiology and management challenges in the SA context. This has led to recent revision of the national HBV infection management guidelines. Research on developing new vaccines and therapies is underway and progress has been made with designing potentially curative gene therapies against HBV. This review summarizes research carried out in SA on HBV molecular biology, epidemiology, treatment, and vaccination strategies.

Background: Health costs have increased significantly around the world, and cost assessments have become important. This study aimed to collect cost of the resources used in the national hepatitis B immunization program in Southern Iran., Methods: Costs were calculated by investigating the available documents as well as consulting with knowledgeable personnel. These costs were collected using the data from Shiraz University of Medical Sciences. According to the health payer's perspective, the indirect costs of the people were not taken into account. All current and capital costs in year 2017 were calculated and converted to US dollars (USDs)., Results: In 2017, 33 204 children received hepatitis B vaccine. The total cost of the national hepatitis B vaccination program in Shiraz and the cost of vaccination per child were 473 506 and 14.26 USD, respectively. However, the cost of inoculation of hepatitis B vaccine per dose was estimated at 3.20 USD. Personnel costs constituted the highest proportion (53.84%) of total costs., Conclusions: The cost of hepatitis B vaccination in Iran was lower than other countries. Considering that personnel costs had the largest proportion, it is recommended that proper measures be taken to monitor and modify these costs if necessary., (© The Author(s) 2021. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Aim: To identify the key risk factors of intrauterine hepatitis B virus transmission (HBV) and its effect on the placenta and fetus. Methods: 425 infants born to hepatitis B surface antigen (HBsAg)-positive pregnant women who received combined immunization with hepatitis B immunoglobulin and hepatitis B vaccine between 2009 to 2015 were prospectively enrolled in this study. The intrauterine transmission situation was assessed by dynamic monitoring of infants HBV DNA load and quantitative HBsAg. Univariate and multivariate regression analysis was used to determine the high risk factors for intrauterine transmission. Stratified analysis was used to determine the relationship between maternal HBV DNA load and fetal distress. Transmission electron microscopy was used to observe HBV Effects on placental tissue. Results: HBV intrauterine infection rate was 2.6% (11/425). Multivariate analysis result showed that the maternal HBV DNA load was an independent risk factor for intrauterine infection among infants ( P =0.011). Intrauterine infection and distress rate was significantly higher in infants with with maternal HBV DNA>10 6 IU/ml than those with HBV DNA <10 6 IU/ml (12.2% vs . 1.8%; χ 2 =11.275, P =0.006), and (24.4% vs . 16.0%, χ 2 =3.993, P =0.046). Transmission electron microscopy showed that mitochondrial edema, endoplasmic reticulum expansion and thicker basement membrane were apparent when the maternal HBV DNA>10 6 IU/ml than that of maternal HBV DNA<10 6 IU/ml (960 nm vs . 214 nm, Z =-2.782, P =0.005) in the placental tissue. Conclusion: Maternal HBV DNA>10 6 IU/ml is associated not only with intrauterine infection, but also with increased incidence of intrauterine distress and placental sub-microstructural changes, providing strong clinical and histological evidence for pregnancy avoidance and treatment in this population.

Background: Chronic hepatitis B (CHB) infection remains a significant public health issue for Indigenous Australians, in particular for remote communities., Aim: To evaluate the spectrum of hepatitis B virus (HBV) care provided to a remote Aboriginal community. Measures studied included screening, seroprevalence, vaccination rates and efficacy, and HCC risk and surveillance adherence., Methods: A retrospective audit of HBV care received by all permanent residents currently attending a remote Aboriginal Health service. This study was endorsed by both the local Aboriginal Health service and the Aboriginal Health Council of South Australia., Results: A total of 208 patients attended the clinic, of whom 52% (109) were screened for HBV. Of these, 12% (13) had CHB and 20% (22) had evidence of past infection. Similarly, of the 208 attending patients, complete vaccination was documented in 48% (99). Of the 33 patients with post-vaccination serology, 24% (8) had subtherapeutic (<10 IU/mL) levels of HBsAb. Subtherapeutic HBsAb was independently associated with higher Charlson Comorbidity scores (odds ratio = 17.1; 95% confidence interval 1.2-243.3; P = 0.036). Definitive breakthrough infection was identified in 6% (2) patients. One HBsAg positive patient was identified as needing HCC surveillance, but had not undertaken HCC surveillance., Conclusion: Opportunities to improve the quality of CHB care through increased HBV vaccination, screening and adherence to HCC surveillance were identified. High rates of subtherapeutic vaccine responses and documented breakthrough infection raises concerns about the effectiveness of current CHB vaccines in this population., (© 2021 Royal Australasian College of Physicians.)

Background: There is a four-fold risk for hepatitis B infection among healthcare workers compared to the general population. Due to limited access to diagnosis and treatment of hepatitis B in many resource-constrained settings, there is a real risk that only few healthcare workers with viral hepatitis may get screened or diagnosed and treated. Studies on hepatitis B vaccination among healthcare workers in developing countries are sparse and this bodes ill for intervention and support. The aim of the study was to estimate the prevalence and explored the associated factors that predicted the uptake of the required, full dosage of hepatitis B vaccination among healthcare workers (HCWs) in five developing countries using nationally representative data., Methods: We used recent datasets from the Demographic and Health Surveys Program's Service Provision Assessment Survey. Descriptive summary statistics and logistic regressions were used to produce the results. Statistical significance was pegged at p < 0.05., Results: The proportion of HCWs who received the required doses of hepatitis B vaccine in Afghanistan, Haiti, Malawi, Nepal, and Senegal were 69.1%, 11.3%, 15.4%, 46.5%, and 17.6%, respectively. Gender, occupational qualification, and years of education were significant correlates of receiving the required doses of hepatitis B among HCWs., Conclusions: Given the increased risk of hepatitis B infection among healthcare workers, policymakers in developing countries should intensify education campaigns among HCWs and, perhaps, must take it a step further by making hepatitis B vaccination compulsory and a key requirement for employment, especially among those workers who regularly encounter bodily fluids of patients., (© 2022. The Author(s).)

Introduction: Hepatitis B is a potentially deadly infection that can be acquired by exposure to infectious human blood or body fluids. While service members and others at occupational risk are routinely vaccinated to prevent hepatitis B, non-responders to this vaccine are at continued risk. Heplisav-B is a newer vaccine that may offer additional protection to those at risk., Materials and Methods: Cases of hepatitis B vaccine non-responders who were given Heplisav-B after receiving six or more doses of standard hepatitis B vaccine were collected from existing health records within the military health system after Uniformed Services University of the Health Sciences Institutional Review Board review., Results: Twelve of thirteen (92%) prior non-responders who were tested at least 1 month after completing the recombinant Heplisav-B vaccine series demonstrated seroprotection against hepatitis B., Conclusions: Ideally, all service members and other at-risk workers should be protected from hepatitis B. This case series suggests that prior non-responders are likely to gain protection from hepatitis B with Heplisav-B vaccination. A prospective trial is warranted for further evaluation of this potential indication., (© The Association of Military Surgeons of the United States 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The hepatitis B virus (HBV) is highly infectious, with over 292 million chronically infected people worldwide and up to 2.4 million in the United States. Following infection, clinically silent liver damage can ensue, but symptoms or signs of advanced disease, including cirrhosis and hepatocellular carcinoma, can take decades to emerge. HBV has the heaviest public health burden of all hepatitis viruses and has now surpassed other major communicable diseases (eg, HIV, diarrheal disease, malaria, tuberculosis) as a leading cause of death globally. Preventing transmission is essential, and efforts are in place to reinforce screening, vaccination, and routine follow-up. Three safe and effective vaccines are available in the United States and other countries for HBV prevention, and the benefits of vaccination in preventing infection and its sequelae have been substantiated. For the first time in over 25 years, a new Food and Drug Administration-approved vaccine is available that offers a high degree of immunogenicity after 2, rather than 3, injections. Persistent challenges include the underutilization of vaccination, choice of vaccine, incomplete vaccinations, varying needs in different populations, management of nonresponders or those with undocumented or incompletely documented vaccination courses, and questions about whether and when booster injections may be needed. A panel of US academic hepatologists with expertise and experience in preventing and managing HBV infection have collaborated to write this practical clinical paper intended to guide clinicians in vaccinating for HBV and address questions that regularly arise in the clinic., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Despite comprising less than 6% of the US population, Asian individuals make up more than half of the approximately 1.6 million chronic hepatitis B virus (HBV) infections in the United States. The purpose of this investigation was to identify characteristics associated with HBV knowledge in this disproportionately affected population., Methods: A cross-sectional, multilingual survey study using convenience sampling was conducted in a Midwestern urban city to collect information on respondents' demographics, health care access, and HBV knowledge. Hepatitis B virus knowledge was categorized into epidemiology, natural history, transmission, and vaccination. Data were analyzed using Kruskal-Wallis and Spearman correlation tests., Results: Of the 174 individuals who completed surveys, 139 (79.9%) were Asian. Characteristics of univariate analyses associated with higher knowledge scores included younger age (18-49 years), proficiency in reading English, college education, current employment status, physician using preferred language, last physician's visit in 2018 or prior, perceived lack of time to see a physician, use of emergency department, prior HBV vaccination, prior HBV testing, higher level of self-reported knowledge about HBV, and acquiring health information from the Internet, messaging applications, friends, and family (P < .05). In the multivariable analysis, shorter residency in the United States (0-10 years), current employment status, having heard of HBV, and confidence in their HBV knowledge were associated with higher knowledge scores., Conclusion: Knowledge deficits existed in our study population regarding HBV transmission, vaccination, and epidemiology, while knowledge was higher regarding HBV natural history. Education efforts should be designed to improve knowledge deficits about HBV for individuals with risk factors using culturally sensitive Internet and social media platforms., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

The aim of our study was to compare the efficacy of two dosages of hepatitis B immunoglobulin (HBIG) combined with HBV vaccine (HBVac) to prevent mother-to-child transmission (MTCT) of hepatitis B in HBsAg- and HBeAg-positive mother. We enrolled 331 mother-infant pairs with HBsAg- and HBeAg-positive maternal state from the Women's Hospital School of Medicine of Zhejiang University. Newborns were randomly distributed into two groups according to the dosages of HBIG injection: 100 IU and 200 IU. Newborns from both groups were injected with HBVac in the same doses. We compared the immune outcomes between the two groups and explore the influencing factors of immune outcomes through regression analysis. There was no statistically significant relationship between HBsAg serological transmission of newborns and dosages of HBIG in HBsAg- and HBeAg-positive mother ( p >  .05). The Logistic regression showed that high DNA load is a risk factor for passive-active immunoprophylaxis failure for both 100 IU and 200 IU group, but higher-dosage HBIG is not necessary for higher-viral-load pregnant women with HBsAg- and HBeAg-positive. In conclusion, combined application of HBVac and a single dose of 100 IU HBIG can achieve the ideal MTCT interruption results for HBsAg- and HBeAg-positive pregnant women.IMPACT STATEMENT What is already known on this subject? Passive-active immunoprophylaxis is proved to be effective in preventing mother-to-child transmission of hepatitis B. Hepatitis B vaccine combined with 100 IU or 200 IU immunoglobulin is mostly recommended in China. What do the results of this study add? At present, there is still a lack scientific basis for improving existing strategies and measures to prevent mother-to-child transmission of hepatitis B in China. What are the implications of these findings for clinical practice and/or further research? 100 IU and 200 IU immunoglobulin show equivalent blocking effect, and combined use of hepatitis B vaccine and 100 IU immunoglobulin is more cost-effective.