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Introduction: In 2023, recombinant zoster vaccine (RZV) replaced zoster vaccine live (ZVL) vaccine in the UK National Immunisation Programme (NIP) for prevention of herpes zoster (HZ). The vaccination age was reduced from 70 to 65 years, with a subsequent planned reduction to 60 years. This modelling study aimed to evaluate the public health impact (PHI) of RZV vaccination in the 70 years of age (YOA) population and in younger individuals 65 and 60 YOA. Methods: PHI was evaluated from a National Health Service perspective, as cases of HZ, post-herpetic neuralgia (PHN), non-PHN complications and deaths, hospitalisations, and general practitioner (GP) visits avoided using a multicohort Markov model. Three scenarios (RZV vs. no vaccination, ZVL vs. no vaccination, and RZV vs. ZVL) were explored for each age group using population estimates from the UK Office for National Statistics, i.e. 70 YOA (n = 649,822), 65 YOA (n = 760,578) and 60 YOA (n = 849,501). Results: Modelled outcomes in 70 YOA individuals estimated that RZV vaccination would avoid 32,894 cases of HZ and 5915 cases of PHN compared with no vaccination and 26,954 HZ and 3218 PHN cases compared with ZVL. Compared with no vaccination, 2264 fewer hospitalisations and 158,549 fewer GP visits were predicted with RZV vaccination. Hospitalisations were predicted to be reduced by 1996 and GP visits by 130,821 for RZV versus ZVL vaccination. In individuals 65 YOA, it was estimated that RZV vaccination would avoid 50,128 HZ cases, 8623 PHN cases, 222,646 GP visits, and 2671 hospitalisations versus no vaccination. In the 60 YOA group, RZV vaccination was predicted to avoid 57,182 HZ cases, 9327 PHN cases, 234,330 GP visits, and 2547 hospitalisations versus no vaccination. Conclusion: The recent introduction of RZV into the NIP could substantially reduce HZ disease burden and healthcare resource use in the UK. A graphical abstract is available with this article. [ABSTRACT FROM AUTHOR]

Introduction The use of novel adjuvants in human vaccines continues to expand as their contribution to preventing disease in challenging populations and caused by complex pathogens is increasingly understood. AS01 is a family of liposome-based vaccine Adjuvant Systems containing two immunostimulants: 3-O-desacyl-4’-monophosphoryl lipid A and the saponin QS-21. AS01-containing vaccines have been approved and administered to millions of individuals worldwide.Areas covered Here, we report advances in our understanding of the mode of action of AS01 that contributed to the development of efficacious vaccines preventing disease due to malaria, herpes zoster, and respiratory syncytial virus. AS01 induces early innate immune activation that induces T cell-mediated and antibody-mediated responses with optimized functional characteristics and induction of immune memory. AS01-containing vaccines appear relatively impervious to baseline immune status translating into high efficacy across populations. Currently licensed AS01-containing vaccines have shown acceptable safety profiles in clinical trials and post-marketing settings.Expert opinion Initial expectations that adjuvantation with AS01 could support effective vaccine responses and contribute to disease control have been realized. Investigation of the utility of AS01 in vaccines to prevent other challenging diseases, such as tuberculosis, is ongoing, together with efforts to fully define its mechanisms of action in different vaccine settings.

Background and Clinical Significance: The recombinant zoster vaccine (Shingrix) helps prevent shingles and its complications in adults 50 and older. While minor side effects are common, severe adverse reactions are thought to be rare, and long-term side effects are not well documented. Case Presentation: A 50-year-old woman with Crohn's disease developed joint pain, effusion, and neurological symptoms such as numbness and tingling shortly after receiving the first dose of the recombinant zoster vaccine. Symptoms waxed and waned but persisted for over a year despite anti-inflammatories and specialist referrals. Diagnostic imaging and labs were unrevealing. Conclusions: This case of prolonged somatic and neurological symptoms associated temporally with Recombinant zoster vaccine administration reinforces the critical need for thorough pharmacovigilance and investigation of possible long-term adverse vaccine reactions. Provider documentation and reporting of individual experiences can help improve the detection of rare vaccine-related risks, elucidate potential risk factors, and refine safety screening. Diligent monitoring and research into longitudinal vaccine outcomes remain paramount, especially following recent emergency authorizations. [ABSTRACT FROM AUTHOR]

The burden of herpes zoster (HZ) is recognized worldwide; however, there is seemingly limited information on incidence and vaccination practices in Southeast Asia (SEA). A scientific workshop was held by the Zoster Experts' Network to exchange and consolidate insights on the burden of HZ and the patient pathway in SEA. The workshop included practicing clinical experts and public health specialists/epidemiologists from Indonesia, Malaysia, the Philippines, Thailand, and Vietnam. It aimed to identify gaps in the literature, outline patient pathways, and evaluate HZ vaccine recommendations among these countries. Consensus was identified on the substantial lack of epidemiological data on HZ in SEA and the need to investigate the impact of age, immunocompromising conditions, and comorbidities on the incidence and severity of HZ in the region. However, available data in SEA did indicate a rising disease and socioeconomic burden of HZ, with concerns that current treatment strategies for HZ are suboptimal. The HZ patient pathways generated by the experts highlighted common themes and differences between the five countries. Furthermore, the experts highlighted the lack of awareness of HZ and its impact on patients' quality of life, among patients and healthcare professionals. Evaluation of the current local HZ vaccine recommendations further showed differences in age and the inclusion of at-risk populations between countries. The workshop outcomes emphasize the need for further HZ surveillance in SEA. Efforts to align and address leakage within the patient pathway and raise awareness on the impact of HZ should be prioritized. Awareness initiatives and alignment on vaccine recommendations are also needed. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to evaluate the safety profile of the recombinant zoster vaccine (RZV) after its marketing in China. Methods: We present a descriptive analysis and safety signal assessment of adverse events following immunization (AEFI) associated with RZV between September 2020 and December 2023. The descriptive data collected includes demographic characteristics and the classification of characteristics of AEFI cases, while vaccine safety signal assessment was evaluated using the reporting odds ratio (ROR). Results: In total, we documented 275 AEFI cases following RZV vaccination, with a reporting rate of 76.22/10,000 doses administered. Notably, only one case was classified as serious, and the reporting rates were significantly higher among females, individuals aged 50–59 years, and those residing in rural areas. Furthermore, the reporting rate for the first dose exceeded that for the second dose. Among the reported AEFI cases, 98.91% were attributed to vaccine product-related reactions, and 97.45% were initially reported by either the vaccine recipient or their guardians. The interval between vaccination and symptom onset was predominant within 3 d after vaccination. The disproportionality analysis identified five positive signals—fever (37.5–38.5 °C), injection site reactions greater than 5 cm, pain, Henoch Schönlein purpura (HSP), and swelling—which suggests a stronger association with the RZV than the expected threshold. Conclusion: In summary, RZV demonstrated a favorable safety profile. However, continued monitoring and research on the long-term safety implications of RZV are needed. [ABSTRACT FROM AUTHOR]

Recombinant zoster vaccine (RZV) is recommended for individuals ≥ 50 years of age for protection against herpes zoster (HZ). This study quantifies RZV coverage and assesses predictors for RZV vaccination using a U.S. claims database. Univariate linear regression provided annual prevalence of RZV vaccination and multivariable logistic regression provided ORs and 95% CIs for associations between predictors and RZV vaccination. A total of 4,124,315 individuals (19,080,914 person-years) were included in this study. Since receiving FDA approval for the prevention of HZ, RZV coverage (of at least one dose) has reached approximately 17% within the eligible U.S. population by January 2021, although significant disparities between demographic groups were noted. Our findings suggest that HZ vaccine coverage may be reduced below goal in the U.S. and highlights the importance of continuing to monitor RZV vaccination. Additionally, as our study found disparities in vaccine coverage, attention towards marginalized and medically underserved populations is needed.

Recombinant zoster vaccine has been recommended by the US Advisory Committee on Immunization Practices (ACIP) for the prevention of herpes zoster (HZ) in immunocompetent adults aged at least 50 years since 2018. In January 2022, this was extended to immunodeficient/immunosuppressed adults aged at least 19 years. Key study objectives were to assess specialists' knowledge of the ACIP HZ vaccination recommendations, their attitudes toward HZ vaccination, and HZ vaccination practices/barriers. This cross-sectional, web-based survey (conducted in March 2022) included US dermatologists, gastroenterologists, infectious disease specialists, oncologists, and rheumatologists who treat patients with psoriasis, inflammatory bowel disease, human immunodeficiency syndrome, solid tumors/hematological malignancies, and rheumatoid arthritis, respectively. Although most of the 613 specialists correctly identified the ACIP HZ vaccination recommendations for adults aged at least 50 years (84%) and immunodeficient/immunosuppressed adults aged at least 19 years (67%), only 29% knew that recombinant zoster vaccine is recommended for individuals who have previously received zoster vaccine live, and only 18% knew all current ACIP recommendations. For patients with the diseases listed, 84% of specialists thought that HZ is a serious risk, 75% that HZ vaccination is extremely/very important, and 69% were extremely/very likely to recommend HZ vaccination. Only 36% administer vaccines themselves, mainly because patients receive vaccinations from others. Barriers to vaccination included more urgent/acute issues, insufficient time, and lack of patient motivation/willingness. Full knowledge of the ACIP HZ vaccination recommendations among the surveyed specialists was low. There may be a need to educate specialists to improve adherence to these recommendations. [ABSTRACT FROM AUTHOR]

The varicella-zoster virus (VZV) is a human neurotropic herpes virus responsible for varicella and herpes zoster (HZ). Following primary infection in childhood, VZV manifests as varicella (chickenpox) and enters a period of latency within the dorsal root ganglion. A compromised cellular immune response due to aging or immunosuppression triggers viral reactivation and the development of HZ (shingles). Patients with autoimmune diseases have a higher risk of developing HZ owing to the immunodeficiency associated with the disease itself and/or the use of immunosuppressive agents. The introduction of new immunosuppressive agents with unique mechanisms has expanded the treatment options for autoimmune diseases but has also increased the risk of HZ. Specifically, Janus kinase (JAK) inhibitors and anifrolumab have raised concerns regarding HZ. Despite treatment advances, a substantial number of patients suffer from complications such as postherpetic neuralgia for prolonged periods. The adjuvanted recombinant zoster vaccine (RZV) is considered safe and effective even in immunocompromised patients. The widespread adoption of RZV may reduce the health and socioeconomic burdens of HZ patients. This review covers the link between VZV and autoimmune diseases, assesses the risk of HZ associated with immunosuppressant use, and discusses the benefits and risks of using RZV in patients with autoimmune diseases. [ABSTRACT FROM AUTHOR]

ABSTRACTWe evaluated the vaccine effectiveness (VE) of two doses of recombinant zoster vaccine (RZV) against herpes zoster (HZ) and postherpetic neuralgia (PHN) in Chinese adults at Kaiser Permanente Southern California (KPSC). Chinese KPSC members were identified based on self-reported ethnicity or self-reported preferred spoken/written language. Those aged ≥50 years who received two doses of RZV 4 weeks to ≤ 6 months apart were matched 1:4 to RZV unvaccinated Chinese members and followed through June 2022; second doses were accrued 6/1/2018–12/31/2020. We estimated incidence and adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs) comparing outcomes (HZ and PHN). Adjusted VE (%) was calculated as (1−aHR)×100. 3978 RZV vaccinated Chinese members were matched to 15,912 RZV unvaccinated Chinese members. The incidence per 1000 person-years (95% CI) of HZ in the vaccinated group was 1.5 (0.9–2.5) and 10.9 (9.8–12.1) in the unvaccinated group; aHR (95% CI) was 0.12 (0.07–0.21). Adjusted VE (95% CI) was 87.6% (78.9–92.7) against HZ. We identified 0 PHN cases in the vaccinated group and 19 in the unvaccinated group. Among Chinese adults aged ≥50 years, two doses of RZV provided substantial protection against HZ and PHN supporting the real-world effectiveness of the vaccine in this population.

The recombinant zoster vaccine (RZV) is included in the Spanish National Immunisation Programme for adults 65 years of age (years), with a potential progressive catch-up program for adults 66–80 years, starting with 80 years. However, the risk of herpes zoster (HZ) increases significantly from 50 years. We estimated the public health impact (PHI) of vaccinating adults ≥50 years in Spain versus no vaccination, using a Markov model adapted to the Spanish setting. The model simulated a hypothetical ≥50 years cohort over a lifetime, with inputs from Spanish publications, databases, or publications from other countries where Spanish data were unavailable. Base case inputs included 67.7% RZV coverage and 61.1% second dose compliance. Outputs included clinical outcomes avoided, healthcare resource use avoided, and number-needed-to-vaccinate (NNV) to prevent one HZ case. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were also conducted. The model estimated that, compared with no vaccination, vaccinating adults ≥50 years in Spain (N = 19,850,213) with RZV could prevent 1,533,353 HZ cases, 261,610 postherpetic neuralgia episodes, 274,159 other complications, and 138 deaths through the cohorts’ remaining lifetime, mostly in the 50–59 years cohort. Furthermore, 3,500,492 primary care visits and 71,156 hospitalizations could be avoided, with NNV = 9 to prevent one HZ case. DSA predicted NNV = 7 to prevent one HZ case when second dose compliance was increased to 100%. PSA demonstrated ≥200,000 and ≥1,400,000 cases could be prevented in 86.9% and 18.4% of simulations, respectively. Starting RZV from 50 years could therefore prevent a substantial number of HZ cases and complications. Increasing RZV coverage and second dose compliance could further alleviate PHI of HZ.

Background Recombinant zoster vaccine [RZV] reduces the short-term risk of herpes zoster [HZ] in patients with inflammatory bowel disease [IBD]. However, there is lack of data regarding the long-term effectiveness in this population. Methods A retrospective cohort study was conducted in adults ≥50 years old using TriNetX database between patients with IBD who received two doses of RZV [IBD-RZV cohort] and patients who did not receive RZV [IBD control cohort]. The primary outcome was risk of incident HZ. One-to-one propensity score matching was performed for demographic parameters, comorbid conditions, and IBD medications. Risk was expressed as adjusted odds ratio [aOR] with 95% confidence intervals [CI]. Results The IBD-RZV cohort [ n  = 5489; mean age 63.2 ± 9.1 years; 57.2% females] was identified with a mean follow-up of 900.9 days. IBD-RZV cohort had a lower risk of HZ [aOR 0.44, 95% CI 0.32-0.62] compared with IBD control cohort. The risk of HZ was lower in patients aged 50–65 years [aOR 0.41, 95% CI 0.25-0.68] and patients >65 years [aOR 0.64, 95% CI 0.42-0.96]. There was a lower risk of HZ in patients with ulcerative colitis [aOR 0.41, 95% CI 0.27-0.63] and Crohn's disease [aOR 0.44, 95% CI 0.26-0.74] in the IBD-RZV cohort compared with IBD control cohort. Conclusion RZV is associated with a lower long-term risk of HZ in patients ≥50 years old with IBD. Given the widespread availability and safety of RZV, more effective vaccination strategies are needed to improve RZV use in this high-risk population. [ABSTRACT FROM AUTHOR]

Background: The adjuvanted recombinant zoster vaccine (RZV), consisting of varicella-zoster virus glycoprotein E (gE) and the AS01B adjuvant system, effectively prevents herpes zoster (HZ). In the absence of a well-defined correlate of protection, it is important to monitor the RZV immune response, as a proxy of clinical effectiveness. Methods: This systematic review examined post-vaccination parameters: humoral and cell-mediated immunity, avidity index, geometric mean concentration of antibody (GMC), and immunity persistence. The meta-analysis used a random-effects model, and subgroup and meta-regression analyses were conducted. Results: Among 37 included articles, after one month from RZV-dose 2, the pooled response rate for anti-gE humoral immunity was 95.2% (95%CI 91.9–97.2), dropping to 77.6% (95%CI 64.7–86.8) during immunosuppression. The anti-gE cell-mediated immunity-specific response reached 84.6% (95%CI 75.2–90.9). Varying factors, such as age, sex, coadministration with other vaccines, prior HZ, or live-attenuated zoster vaccine, did not significantly affect response rates. RZV induced a substantial increase in gE avidity. Immunity persistence was confirmed, with more rapid waning in the very elderly. Conclusions: This systematic review indicates that RZV elicits robust immunogenicity and overcomes immunocompromising conditions. The findings underscore the need for further research, particularly on long-term immunity, and have the potential to support HZ vaccination policies and programs. [ABSTRACT FROM AUTHOR]

• Since 2021 Recombinant Zoster Vaccine is offered in Italy to high-risk patients. • Safety profile was acceptable, as most AEFI were local with remission within 7 days. • Post-vaccination flare-ups were rare and more frequent in rheumatologic patients. • Few cases of mild post-vaccination HZ episodes occurred. • RZV use should be encouraged to decrease the burden of HZ in high-risk patients. Since 2021 a recombinant adjuvanted anti-Herpes Zoster vaccine(Recombinant Zoster Vaccine, RZV) is offered in Italy to high-risk patients. Few real-life data about RZV safety are available in target populations. This study investigates Adverse Events Following Immunization(AEFIs), baseline disease flare-ups, and Herpes Zoster (HZ) episodes occurring after RZV administration in a heterogeneous population of fragile patients to design its safety profile. This is a retrospective population-based study. RZV-vaccinated patients at Bari Policlinico General Hospital vaccination clinic from October 1st, 2021, to March 31st, 2023, were enrolled. Subjects were screened for reason of RZV eligibility and baseline chronic pathologies. AEFIs occurred in the first 7-days post-vaccination period were collected, and baseline disease flare-ups and post-vaccination HZ episodes were assessed via a 3-month follow-up. Five-hundred-thirty-eight patients were included and total of 1,031 doses were administered. Most patients were vaccinated due to ongoing immunosuppressive therapy(54.65 %); onco-hematological and cardiovascular conditions were the most common chronic baseline pathologies. Out of 1,031 follow-ups, 441 AEFI cases were reported(42.7/100). The most common symptoms were injection site pain/itching(35.60/100), asthenia/malaise(11.44/100), and fever (10.09/100). Four serious AEFIs occurred(0.38/100). Older age, male sex, and history of cardiovascular diseases(OR:0.71; 95CI:0.52-0.98; p-value <0.05) were found to decrease AEFIs risk, while endocrine-metabolic illnesses(OR:1.61; 95CI:1.15-2.26; p-value <0.05) increased it. Twelve patients(2.23 %) reported a flare-up/worsening of their baseline chronic condition within the first three months after vaccination(mean interval 31.75 days, range 0–68 days). Patients with rheumatological illnesses had a higher risk of relapse(OR:16.56; 95CI:3.58-76.56; p-value <0.001), while male sex behaved as a protective factor. Twelve patients who completed the vaccination cycle(2.43%) had at least one HZ episode by the long-term follow-up. The study demonstrates RZV safety in a significant number of high-risk patients. Hence, RZV should be actively offered as part of tailored vaccination programs to decrease the burden of HZ in fragile populations. [ABSTRACT FROM AUTHOR]

Introduction: Herpes zoster (HZ) can cause substantial patient morbidity and lead to large healthcare costs. However, the disease burden of HZ in Southeast Asia may be underestimated. This study aimed to estimate the public health burden of HZ and the impact of vaccinating adults aged ≥ 50 years old in five Southeast Asian countries (Indonesia, Malaysia, Philippines, Thailand, and Vietnam), with adjuvanted recombinant zoster vaccine (RZV) compared with no vaccination. Methods: For each country, we adapted a static multicohort Markov model developed with a 1-year cycle length and lifetime horizon. Demographics were obtained from the World Health Organization, HZ incidence from a worldwide meta-regression reporting Asian-specific values, proportions of postherpetic neuralgia (PHN) and non-PHN complications from local/regional studies, and vaccine efficacy from a long-term follow-up trial. First-dose coverage and second-dose compliance were assumed to be 30% and 70%, respectively. A one-way deterministic sensitivity analysis (OWSA) and probabilistic sensitivity analysis (PSA) were performed to assess the robustness and uncertainty of inputs for each country. Results: Without RZV, it was estimated that there would be a total of approximately 10 million HZ cases, 2.1 million PHN cases, and 1.4 million non-PHN complications in individuals aged ≥ 50 years included in the model. Introducing RZV under 30% coverage could avoid approximately 2.2 million (22%) HZ cases, almost 500,000 (21%) PHN cases, and around 300,000 (22%) non-PHN complications. OWSA showed that first-dose coverage and initial HZ incidence had the largest impact on the estimated number of HZ cases avoided. The number needed to vaccinate ranged from 15 to 21 to prevent one case of HZ and from 68 to 104 to prevent one case of PHN across each country. Conclusions: This study demonstrated that there is substantial HZ disease burden in older adults for the five selected countries in Southeast Asia, negatively impacting national healthcare systems. Introducing RZV could potentially reduce this burden. A graphical abstract is available with this article. [ABSTRACT FROM AUTHOR]

Abstract Background The burden of herpes zoster (shingles) virus and associated complications, such as post-herpetic neuralgia, is higher in older adults and has a significant impact on quality of life. The incidence of herpes zoster and post-herpetic neuralgia is increased in people living with HIV (PLWH) compared to an age-matched general population, including PLWH on long-term antiretroviral therapy (ART) with no detectable viremia and normal CD4 counts. PLWH – even on effective ART may- exhibit sustained immune dysfunction, as well as defects in cells involved in the response to vaccines. In the context of herpes zoster, it is therefore important to assess the immune response to varicella zoster virus vaccination in older PLWH and to determine whether it significantly differs to that of HIV-uninfected healthy adults or younger PLWH. We aim at bridging these knowledge gaps by conducting a multicentric, international, non-randomised clinical study (SHINGR’HIV) with prospective data collection after vaccination with an adjuvant recombinant zoster vaccine (RZV) in two distinct populations: in PLWH on long-term ART (> 10 years) over 50 years of and age/gender matched controls. Methods We will recruit participants from two large established HIV cohorts in Switzerland and in France in addition to age-/gender-matched HIV-uninfected controls. Participants will receive two doses of RZV two months apart. In depth-evaluation of the humoral, cellular, and innate immune responses and safety profile of the RZV will be performed to address the combined effect of aging and potential immune deficiencies due to chronic HIV infection. The primary study outcome will compare the geometric mean titer (GMT) of gE-specific total IgG measured 1 month after the second dose of RZV between different age groups of PLWH and between PLWH and age-/gender-matched HIV-uninfected controls. Discussion The SHINGR’HIV trial will provide robust data on the immunogenicity and safety profile of RZV in older PLWH to support vaccination guidelines in this population. Trial registration ClinicalTrials.gov NCT05575830. Registered on 12 October 2022. Eu Clinical Trial Register (EUCT number 2023-504482-23-00).

Objectives: This study aimed to evaluate the safety profile of the recombinant zoster vaccine (RZV) after its marketing in China. Methods: We present a descriptive analysis and safety signal assessment of adverse events following immunization (AEFI) associated with RZV between September 2020 and December 2023. The descriptive data collected includes demographic characteristics and the classification of characteristics of AEFI cases, while vaccine safety signal assessment was evaluated using the reporting odds ratio (ROR). Results: In total, we documented 275 AEFI cases following RZV vaccination, with a reporting rate of 76.22/10,000 doses administered. Notably, only one case was classified as serious, and the reporting rates were significantly higher among females, individuals aged 50–59 years, and those residing in rural areas. Furthermore, the reporting rate for the first dose exceeded that for the second dose. Among the reported AEFI cases, 98.91% were attributed to vaccine product-related reactions, and 97.45% were initially reported by either the vaccine recipient or their guardians. The interval between vaccination and symptom onset was predominant within 3 d after vaccination. The disproportionality analysis identified five positive signals—fever (37.5–38.5 °C), injection site reactions greater than 5 cm, pain, Henoch Schönlein purpura (HSP), and swelling—which suggests a stronger association with the RZV than the expected threshold. Conclusion: In summary, RZV demonstrated a favorable safety profile. However, continued monitoring and research on the long-term safety implications of RZV are needed.

The burden of herpes zoster (HZ) is recognized worldwide; however, there is seemingly limited information on incidence and vaccination practices in Southeast Asia (SEA). A scientific workshop was held by the Zoster Experts’ Network to exchange and consolidate insights on the burden of HZ and the patient pathway in SEA. The workshop included practicing clinical experts and public health specialists/epidemiologists from Indonesia, Malaysia, the Philippines, Thailand, and Vietnam. It aimed to identify gaps in the literature, outline patient pathways, and evaluate HZ vaccine recommendations among these countries. Consensus was identified on the substantial lack of epidemiological data on HZ in SEA and the need to investigate the impact of age, immunocompromising conditions, and comorbidities on the incidence and severity of HZ in the region. However, available data in SEA did indicate a rising disease and socioeconomic burden of HZ, with concerns that current treatment strategies for HZ are suboptimal. The HZ patient pathways generated by the experts highlighted common themes and differences between the five countries. Furthermore, the experts highlighted the lack of awareness of HZ and its impact on patients’ quality of life, among patients and healthcare professionals. Evaluation of the current local HZ vaccine recommendations further showed differences in age and the inclusion of at-risk populations between countries. The workshop outcomes emphasize the need for further HZ surveillance in SEA. Efforts to align and address leakage within the patient pathway and raise awareness on the impact of HZ should be prioritized. Awareness initiatives and alignment on vaccine recommendations are also needed.

Background: The burden of herpes zoster (shingles) virus and associated complications, such as post-herpetic neuralgia, is higher in older adults and has a significant impact on quality of life. The incidence of herpes zoster and post-herpetic neuralgia is increased in people living with HIV (PLWH) compared to an age-matched general population, including PLWH on long-term antiretroviral therapy (ART) with no detectable viremia and normal CD4 counts. PLWH – even on effective ART may- exhibit sustained immune dysfunction, as well as defects in cells involved in the response to vaccines. In the context of herpes zoster, it is therefore important to assess the immune response to varicella zoster virus vaccination in older PLWH and to determine whether it significantly differs to that of HIV-uninfected healthy adults or younger PLWH. We aim at bridging these knowledge gaps by conducting a multicentric, international, non-randomised clinical study (SHINGR'HIV) with prospective data collection after vaccination with an adjuvant recombinant zoster vaccine (RZV) in two distinct populations: in PLWH on long-term ART (> 10 years) over 50 years of and age/gender matched controls. Methods: We will recruit participants from two large established HIV cohorts in Switzerland and in France in addition to age-/gender-matched HIV-uninfected controls. Participants will receive two doses of RZV two months apart. In depth-evaluation of the humoral, cellular, and innate immune responses and safety profile of the RZV will be performed to address the combined effect of aging and potential immune deficiencies due to chronic HIV infection. The primary study outcome will compare the geometric mean titer (GMT) of gE-specific total IgG measured 1 month after the second dose of RZV between different age groups of PLWH and between PLWH and age-/gender-matched HIV-uninfected controls. Discussion: The SHINGR'HIV trial will provide robust data on the immunogenicity and safety profile of RZV in older PLWH to support vaccination guidelines in this population. Trial registration: ClinicalTrials.gov NCT05575830. Registered on 12 October 2022. Eu Clinical Trial Register (EUCT number 2023-504482-23-00). [ABSTRACT FROM AUTHOR]

Background and Objectives: Cardiac patients are particularly at risk of herpes zoster (HZ), which is associated with a higher risk of major cardiovascular events. This research aimed to analyze the knowledge, attitudes and practices towards recombinant zoster vaccine (RZV) among cardiac healthcare professionals (HPs). Materials and Methods: A cross-sectional survey was conducted in a cardiological hospital in Italy. Multivariate regression models were built to identify factors associated with the outcomes of interest. Results: The response rate was 78.2% (154/197). Overall, age > 50 years and immunosuppression were recognized as risk factors for HZ by 38.3% and 75.3% of respondents, respectively. Regarding RZV, 29.1% of the HPs correctly responded about its schedule and 57.6% about the possibility of administration in immunocompromised individuals. This knowledge was significantly higher in HPs with a higher educational level (odds ratio (OR) = 4.42; 95%CI 1.70–11.47), in those who knew that HZ could cause postherpetic neuralgia (OR = 2.56; 95%CI 1.05–6.25) or major cardiovascular events (OR = 4.23; 95%CI 1.50–11.91), in those who had participated in professional updates on vaccinations (OR = 3.86; 95%CI 1.51–9.87) and in those who stated the need for further information about the RZV (OR = 6.43; 95%CI 1.42–29.98). Younger HPs (coefficient (β) = −0.02; 95%CI −0.04–−0.01), those with a positive attitude toward RZV safety (β = 2.92; 95%CI 2.49–3.36) and those who had previously cared for patients with HZ (β = 0.45; 95%CI 0.03–0.88) reported a more positive attitude toward RZV effectiveness. The practice of recommending vaccination was more prevalent in younger HPs (OR = 0.94; 95%CI 0.89–0.99), in those who had a master's degree or higher education (OR = 7.21; 95%CI 1.44–36.08), in those with more positive attitudes toward RZV effectiveness (OR = 7.17; 95%CI 1.71–30.03) and in HPs who had already recommended the vaccine to patients in the past (OR = 4.03; 95%CI 1.08–14.96). Conclusions: Despite being a single-center study, our research brings attention to factors that currently impact cardiac HPs' approaches to RZV. The findings indicate potential measures to enhance HPs' awareness and practices, ultimately aiming to improve vaccination adherence and reduce the burden associated with HZ. [ABSTRACT FROM AUTHOR]

Introduction: The use of novel adjuvants in human vaccines continues to expand as their contribution to preventing disease in challenging populations and caused by complex pathogens is increasingly understood. AS01 is a family of liposome-based vaccine Adjuvant Systems containing two immunostimulants: 3-O-desacyl-4'-monophosphoryl lipid A and the saponin QS-21. AS01-containing vaccines have been approved and administered to millions of individuals worldwide. Areas covered: Here, we report advances in our understanding of the mode of action of AS01 that contributed to the development of efficacious vaccines preventing disease due to malaria, herpes zoster, and respiratory syncytial virus. AS01 induces early innate immune activation that induces T cell-mediated and antibody-mediated responses with optimized functional characteristics and induction of immune memory. AS01-containing vaccines appear relatively impervious to baseline immune status translating into high efficacy across populations. Currently licensed AS01-containing vaccines have shown acceptable safety profiles in clinical trials and post-marketing settings. Expert opinion: Initial expectations that adjuvantation with AS01 could support effective vaccine responses and contribute to disease control have been realized. Investigation of the utility of AS01 in vaccines to prevent other challenging diseases, such as tuberculosis, is ongoing, together with efforts to fully define its mechanisms of action in different vaccine settings. Plain Language Summary: Adjuvants are added to vaccines to increase the immune response produced after vaccination. Adjuvant Systems contain two or more molecules that stimulate the immune system. AS01 is an Adjuvant System that contains two components, MPL and QS-21, that stimulate the immune system. AS01 is included in three approved vaccines: a malaria vaccine for children, a herpes zoster vaccine for older adults, and a respiratory syncytial virus vaccine also for older adults. Vaccines containing AS01 have been extensively evaluated in clinical trials and administered to millions of individuals during market use. These vaccines are effective in preventing disease and have acceptable safety in different age groups. Experiments have been done to investigate how AS01 works in vaccines to produce an efficient immune response that helps to protect against the disease being targeted. A key effect of AS01 is to encourage specific immune cells to produce chemicals that stimulate the immune system. We now know that this effect is due to co-operation between MPL and QS-21. Experiments have shown that AS01 induces a sophisticated immune 'gene signature' in blood within 24 h after vaccination, and people who developed this 'gene signature' had a stronger response to vaccination. AS01 seems to be able to stimulate the immune system of most people – even if they are older or have a weakened immune system. This means that AS01 could be included in other vaccines against other challenging diseases, such as tuberculosis, or could be used in the treatment of some disease, such as chronic hepatitis B. [ABSTRACT FROM AUTHOR]

PurposeTo examine the effectiveness of the recombinant zoster vaccine (RZV) for preventing herpes zoster ophthalmicus (HZO) in the general United States population.DesignRetrospective, observational cohort study.ParticipantsIndividuals enrolled in the OptumLabs Data Warehouse (OLDW; OptumLabs, Cambridge, MA) who were age eligible for herpes zoster (HZ) vaccination (≥50 years of age) from 2018 through 2019. The OLDW is a longitudinal, de-identified administrative claims and electronic health record database of patients in the United States with commercial insurance, Medicare Part D, or Medicare Advantage METHODS: Patients were required to have 365 days or more of continuous enrollment to be eligible. Those with a diagnosis code of HZ or an immunocompromising condition within 1 year before study inclusion were excluded. Vaccination with the RZV was ascertained by Current Procedural Terminology codes, and HZO was ascertained by International Classification of Diseases, Tenth Revision, codes. Cox proportional hazards regression models were used to estimate the hazard ratio of HZO associated with RZV, and inverse-probability weighting was used to control for confounding. Vaccine effectiveness was calculated from hazard ratios.Main outcome measuresIncidence of HZO in vaccinated versus unvaccinated person-times and vaccine effectiveness were assessed.ResultsFrom January 1, 2018, through December 31, 2019, a total of 4 842 579 individuals were included in this study. One hundred seventy-seven thousand two hundred eighty-nine (3.7%) received 2 valid doses of RZV. The incidence rate of HZO was 25.5 cases (95% confidence interval [CI], 17.4-35.8 cases) per 100 000 person-years in the vaccinated group compared with 76.7 cases (95% CI, 74.7-78.7 cases) in the unvaccinated group. The overall adjusted effectiveness of RZV against HZO was 89.1% (95% CI, 82.9%-93.0%).ConclusionsThe effectiveness of RZV against HZO in individuals 50 years of age and older is high in a clinical setting. However, the low vaccination rate in this study highlights the public health need to increase HZV use. Ophthalmologists can play an important role in recommending vaccination to eligible patients.

BackgroundThe recombinant zoster vaccine had over 90% efficacy in preventing herpes zoster in clinical trials. However, its effectiveness outside of a clinical trial setting has not been investigated. This study aimed to assess the effectiveness of the recombinant zoster vaccine in general practice.MethodsA de-identified administrative claims database, the OptumLabs Data Warehouse, was used to conduct this retrospective cohort study to assess the effectiveness of the recombinant zoster vaccine against herpes zoster in nonimmunocompromised, vaccine age-eligible individuals enrolled in the database for ≥365 days.ResultsA total of 4 769 819 adults were included in this study, with 173 745 (3.6%) adults receiving 2 valid doses of the recombinant zoster vaccine. The incidence rate of herpes zoster was 258.8 (95% confidence interval [CI], 230.0-289.4) cases per 100 000 person-years in vaccinated persons compared with 893.1 (95% CI, 886.2-900.0) in unvaccinated persons. Recombinant zoster vaccine effectiveness was 85.5% (95% CI, 83.5-87.3%) overall, with an effectiveness of 86.8% (95% CI, 84.6-88.7%) in individuals 50 to 79 years old compared with 80.3% (95% CI, 75.1-84.3%) in individuals aged 80 and older. In patients with a history of live zoster vaccine within 5 years of study inclusion, vaccine effectiveness was 84.8% (95% CI, 75.3-90.7%).ConclusionsRecombinant zoster vaccine effectiveness against herpes zoster was high in a real-world setting. Given the low vaccine coverage and high effectiveness, a major public health effort is needed to identify and address barriers to vaccination and increase immunization rates.

ObjectiveTo construct a prediction model for the intention of accepting recombinant zoster vaccine(RZV) vaccination among community residents based on reasoned action approach for promoting RZV vaccination in the population. MethodsTotally 1 480 attendees of four community health service centers were recruited with accidental sampling in three districts of Shanghai city for an online survey conducted during October – November 2022. The vaccination intention scale developed by Vissor et al was translated into Chinese and modified to collect participants′ information relevant to accept RZV vaccination. Of the 1 471 individual data from eligible respondents, 981 and 490 were randomly assigned into a training set and a test set. Lasso regression analysis on the data of training set was performed to explore the determinants of RZV vaccination intention. A nomogram prediction model for RZV vaccination intention was constructed using multivariate logistic regression analysis on the data of training set and the performance of the established model was evaluated with the receiver operating characteristic curve (ROC). ResultsThe intention to have RZV vaccination within 6 months was reported by 8.36% (123) of the eligible respondents. The results of Lasso regression analysis screened out nine predictive factors of RZV vaccination intention, including perception ability (β = 0.149), perceived infection risk (β = 0.074), moral norm (β = 0.061), decisional uncertainty (β = – 0.060), general vaccination beliefs (β = – 0.007), never having herpes zoster infection (β = 0.812), perceived cost-benefit (β = – 0.014), social norm (β = 0.019), and attitude (β = 0.003) and the nine factors were used to construct the prediction model. Based on the nomogram of the established prediction model, the possibility to have RZV vaccination within next 6 months is 9.00% for the respondents never having herpes zoster infection and with following scale items′ scores: 7 for perception ability, 7 for perceived infection risk, 7 for moral norm, 7 for decisional uncertainty, 42 for general vaccination beliefs, 28 for perceived cost-benefit, 49 for social norm, and 42 for the attitude towards RZV vaccination. The results of internal and external validation analysis showed that the established model is of good differentiation and calibration（the area under the curve [AUC]training set = 0.717, AUCtest set = 0.689; χ2training set = 9.061, degree of freedom [df]training set = 8, p training set = 0.337, χ2test set = 12.024, dftest set = 8, ptest set = 0.150）. ConclusionPerception ability, perceived infection risk, moral norm, decisional uncertainty, general vaccination beliefs, whether or not having herpes zoster infection, perceived cost-benefit, social norm, and attitude towards RZV vaccination are main predictive factors for RZV vaccination intention among community residents of Shanghai city.

BackgroundThe incidence of herpes zoster (HZ) has been on the rise for decades in the United States. Clinical trials for the recombinant zoster vaccine (RZV) demonstrated vaccine efficacy of over 90% in preventing herpes zoster. However, there is limited information on its effectiveness outside of a clinical trial setting, as well as its effectiveness against herpes zoster ophthalmicus (HZO).MethodsA de-identified electronic health records database from Kaiser Permanente Hawaii (KPH) was used to conduct this retrospective cohort study to assess the effectiveness of the recombinant zoster vaccine against HZ and HZO in immunocompetent, vaccine age-eligible individuals without a prior history of HZ, who were continuously enrolled in KPH for ≥365 days prior to becoming age-eligible for RZV between January 1, 2018, through December 31, 2019.ResultsA total of 78 356 adults were included in this study, with 11 864 (15.1%) adults receiving two valid doses of the recombinant zoster vaccine. The incidence rate of HZ was 325.6 (95% CI: 217.7 to 464.4) cases per 100 000 person-years in vaccinated persons compared to 1063.3 cases per 100 000 person-years (95% CI: 1006.0 to 1122.8) in the unvaccinated group. The incidence rate of HZO was 11.9 (95% CI: 0.7 to 52.3) cases per 100 000 person-years in the vaccinated group compared to 72.1 (95% CI: 58.0 to 88.3) in the unvaccinated group. RZV was 83.5% (95% CI: 74.9% to 89.2%) effective against HZ and 93.3% (95% CI: 48.7% to 99.1%) effective against HZO.ConclusionsRZV has demonstrated high effectiveness against both HZ and HZO outside of a clinical trial setting in the United States. Vaccine coverage is low, emphasizing the need for public health efforts to increase vaccination to reduce morbidity from HZ and HZO.

Purpose: Immunizations have long been pivotal in preventing diseases like HZ (herpes zoster), caused by VZV (varicella zoster virus). This study aims to evaluate the efficacy and safety of the RZV (recombinant zoster vaccine) compared to the ZVL (zoster vaccine live) and to report rare adverse events following RZV administration. Observation: Herein, we report an unusual case of a 59-year-old man who developed a V1-limited rash with a positive HZ PCR (polymerase chain reaction) test following administration of RZV in the United States. Conclusion: The development of RZV has significantly improved the prevention of HZ compared to ZVL. Nevertheless, rare adverse events, such as dermatomal reactions, underscore the importance of ongoing monitoring and research into the immunomodulatory effects of RZV. Physicians should continue to administer the RZV to patients but be cognizant that reactivation may rarely subsequently occur. Case Presentation: The patient with a history of benign prostatic hyperplasia was treated at an outside hospital two days after receiving the RZV complaining of paresthesia and a rash on his nasolacrimal area and forehead. The patient presented to the ED (emergency department), 9 days post-vaccination due to persistence of his symptoms despite use of amoxicillin, valacyclovir, and an unidentified eye drop. The dose of valacyclovir was increased, and he completed 1 g TID (three times a day) PO (per orally) for 10 days with subsequent resolution of symptoms. A positive PCR test confirmed the diagnosis of HZ. Topical mupirocin ointment was initiated and the patient was referred for ophthalmologic evaluation.

Background There is growing consensus that coronavirus disease 2019 booster vaccines may be coadministered with other age-appropriate vaccines. Adding to the limited available data supporting coadministration, especially with adjuvanted vaccines, could enhance vaccine coverage in adults. Methods In this phase 3, randomized, open-label study, eligible adults aged ≥50 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and a first dose of recombinant zoster vaccine (RZV1) 2 weeks apart (Seq group) or concomitantly (Coad group). The second RZV dose (RZV2) was administered 2 months post-RZV1 in both groups. Primary objectives were noninferiority of anti–glycoprotein E (gE) and anti–spike protein antibody responses in the Coad group compared to the Seq group. Safety and further immunogenicity assessments were secondary objectives. Results In total, 273 participants were randomized to the Seq group and 272 to the Coad group. Protocol-specified noninferiority criteria were met. The adjusted geometric mean concentration ratio (Seq/Coad) was 1.01 (95% confidence interval [CI],.89–1.13) for anti-gE antibodies 1 month post-RZV2, and 1.09 (95% CI,.90–1.32) for anti–spike antibodies 1 month post–mRNA-1273 booster. No clinically relevant differences were observed in overall frequency, intensity, or duration of adverse events between the 2 study groups. Most solicited adverse events were mild/moderate in intensity, each with median duration ≤2.5 days. Administration site pain and myalgia were the most frequently reported in both groups. Conclusions Coadministration of mRNA-1273 booster vaccine with RZV in adults aged ≥50 years was immunologically noninferior to sequential administration and had a safety and reactogenicity profile consistent with both vaccines administered sequentially. Clinical Trials Registration.  NCT05047770. [ABSTRACT FROM AUTHOR]

• Recombinant zoster vaccine (RZV) is recommended by ACIP for US adults aged ≥50 years. • Vaccination rates are suboptimal for adults 50–59 years versus ≥50 years overall. • Our study modeled increasing RZV coverage from 7.3 % to 14.6 % in adults 50–59 years. • The model projected avoidance of 504,468 HZ and 42,077 PHN additional cases. • The model projected cost savings of $143,059,299 from a societal perspective. Recombinant zoster vaccine (RZV) is recommended in the US for prevention of herpes zoster (HZ) in adults aged ≥50 years. Vaccination rates remain suboptimal for adults 50–59 years compared with adults ≥50 years overall. The objective of this study was to model changes in outcomes associated with improved RZV vaccination coverage in US adults 50–59 years. A multicohort Markov model compared a scenario using real-world vaccination coverage for US adults 50–59 years in 2020 versus scenarios assuming higher coverage. Outcomes, based on a lifetime horizon, included HZ cases and complications avoided, quality-adjusted life-years (QALY), and costs. Model inputs included HZ epidemiology, RZV vaccine efficacy, coverage, adverse events, and costs, based on published literature and US sources. Some inputs were updated from previous models, including real-world estimates of RZV coverage, series completion, and reflecting longer-term data on waning of vaccine efficacy. The model utilized a cohort size of 42,756,488 individuals based on the 2020 US population census. The model projected that increasing RZV coverage in adults 50–59 years from 7.3 % to 14.6 % (to coverage for adults 60–64 years in 2020) would avoid an additional 504,468 HZ cases, 42,077 postherpetic neuralgia cases, and 56,247 cases of other HZ-associated complications. The increase in vaccine coverage would result in higher vaccination-related costs of $1,172,411,566, but the avoided HZ cases and complications would be expected to result in direct cost savings of $721,973,386 and indirect cost savings of $593,497,480 from avoided productivity loss. Overall, a gain of 5,230 discounted QALYs and cost savings of $143,059,299 from a societal perspective would be realized. Modestly higher RZV coverage in US adults 50–59 years could reduce the clinical burden associated with HZ and may result in societal cost savings. These findings demonstrate the potential value of increasing RZV vaccination in this population. [ABSTRACT FROM AUTHOR]

Background: The adjuvanted recombinant zoster vaccine (RZV), consisting of varicella-zoster virus glycoprotein E (gE) and the AS01B adjuvant system, effectively prevents herpes zoster (HZ). In the absence of a well-defined correlate of protection, it is important to monitor the RZV immune response, as a proxy of clinical effectiveness. Methods: This systematic review examined post-vaccination parameters: humoral and cell-mediated immunity, avidity index, geometric mean concentration of antibody (GMC), and immunity persistence. The meta-analysis used a random-effects model, and subgroup and meta-regression analyses were conducted. Results: Among 37 included articles, after one month from RZV-dose 2, the pooled response rate for anti-gE humoral immunity was 95.2% (95%CI 91.9–97.2), dropping to 77.6% (95%CI 64.7–86.8) during immunosuppression. The anti-gE cell-mediated immunity-specific response reached 84.6% (95%CI 75.2–90.9). Varying factors, such as age, sex, coadministration with other vaccines, prior HZ, or live-attenuated zoster vaccine, did not significantly affect response rates. RZV induced a substantial increase in gE avidity. Immunity persistence was confirmed, with more rapid waning in the very elderly. Conclusions: This systematic review indicates that RZV elicits robust immunogenicity and overcomes immunocompromising conditions. The findings underscore the need for further research, particularly on long-term immunity, and have the potential to support HZ vaccination policies and programs.

Herpes zoster (HZ) is a debilitating viral infection causing a dermatomal vesicular rash. Many known risk factors exist in India and adults >50 years of age may be especially susceptible to HZ. However, HZ is not a notifiable disease in India and data on incidence and disease burden is lacking. An Expert Consensus Group meeting was conducted with experts from relevant specialties to discuss HZ disease, its local epidemiology, and suggestions for implementing HZ vaccination in the Indian healthcare system. Currently, there is lack of patient awareness, poor reporting practices and general negligence in the treatment of the disease. HZ patients generally approach their general physicians or specialists for diagnosis, which is usually based on patient history and clinical symptoms. Recombinant zoster vaccine (RZV) has >90% efficacy and is recommended in adults ≥50 years of age to prevent HZ in the United States. Despite RZV being approved for use, it is not yet available in India. India has a growing elderly population with known risk factors for HZ like immunosuppression, and co-morbidities like diabetes and cardiovascular disease. This indicates the need for a targeted immunization program in India. Meeting also emphasized adult vaccine availability and accessibility in the country.

Although 1 in 3 people globally are expected to develop herpes zoster (HZ; i.e. shingles), HZ vaccination is not currently part of the Philippine National Immunization Program and HZ is not considered as one of the main vaccine-preventable diseases highlighted by the Department of Health. We report the findings from two advisory boards held with healthcare professionals (HCPs) to understand the current landscape of HZ management and prevention in the Philippines. The first advisory board focused on the management and prevention of HZ in patients aged ≥50 years, the second in immunocompromised patients aged ≥18 years. HCPs reported seeing HZ cases across specialties, with the most common complication being postherpetic neuralgia. HZ was reported to impose a substantial burden on patients, due to both the cost of treatment and distress caused due to pain. HZ could also complicate the treatment of ongoing conditions. HCPs agreed that the introduction of the recombinant zoster vaccine, which was recently approved by the Philippines Food and Drug Administration, could help in the prevention of HZ, addressing the needs of both HCPs and patients. Suggested steps to establish HZ vaccination in the Philippines included improved HCP and patient education, and establishing local HZ vaccine recommendations.

Background and Objectives: Cardiac patients are particularly at risk of herpes zoster (HZ), which is associated with a higher risk of major cardiovascular events. This research aimed to analyze the knowledge, attitudes and practices towards recombinant zoster vaccine (RZV) among cardiac healthcare professionals (HPs). Materials and Methods: A cross-sectional survey was conducted in a cardiological hospital in Italy. Multivariate regression models were built to identify factors associated with the outcomes of interest. Results: The response rate was 78.2% (154/197). Overall, age > 50 years and immunosuppression were recognized as risk factors for HZ by 38.3% and 75.3% of respondents, respectively. Regarding RZV, 29.1% of the HPs correctly responded about its schedule and 57.6% about the possibility of administration in immunocompromised individuals. This knowledge was significantly higher in HPs with a higher educational level (odds ratio (OR) = 4.42; 95%CI 1.70–11.47), in those who knew that HZ could cause postherpetic neuralgia (OR = 2.56; 95%CI 1.05–6.25) or major cardiovascular events (OR = 4.23; 95%CI 1.50–11.91), in those who had participated in professional updates on vaccinations (OR = 3.86; 95%CI 1.51–9.87) and in those who stated the need for further information about the RZV (OR = 6.43; 95%CI 1.42–29.98). Younger HPs (coefficient (β) = −0.02; 95%CI −0.04–−0.01), those with a positive attitude toward RZV safety (β = 2.92; 95%CI 2.49–3.36) and those who had previously cared for patients with HZ (β = 0.45; 95%CI 0.03–0.88) reported a more positive attitude toward RZV effectiveness. The practice of recommending vaccination was more prevalent in younger HPs (OR = 0.94; 95%CI 0.89–0.99), in those who had a master’s degree or higher education (OR = 7.21; 95%CI 1.44–36.08), in those with more positive attitudes toward RZV effectiveness (OR = 7.17; 95%CI 1.71–30.03) and in HPs who had already recommended the vaccine to patients in the past (OR = 4.03; 95%CI 1.08–14.96). Conclusions: Despite being a single-center study, our research brings attention to factors that currently impact cardiac HPs’ approaches to RZV. The findings indicate potential measures to enhance HPs’ awareness and practices, ultimately aiming to improve vaccination adherence and reduce the burden associated with HZ.

This study aimed to estimate the cost-effectiveness of the use of recombinant zoster vaccine (RZV) (Shingrix), which protects against herpes zoster (HZ), among immunocompromised adults aged 19 to 49 years, as a contribution to deliberations of the Advisory Committee on Immunization Practices. Hematopoietic cell transplant (HCT) recipients experience a high incidence of HZ, and the efficacy of RZV in preventing HZ has been studied in clinical trials. The cost-effectiveness model calculated incremental cost-effectiveness ratios that compared vaccination with RZV with a no vaccination strategy among adults aged 19 to 49 years. Costs and outcomes were calculated until age 50 years using the healthcare sector perspective and summarized as cost per quality-adjusted life-year (QALY) gained. The base case represents HCT recipients, with scenario analyses representing persons with other immunocompromising conditions, including hematologic malignancies, human immunodeficiency virus, and autoimmune and inflammatory conditions. Uncertainty was investigated using univariate, multivariate, and probabilistic sensitivity analyses. Base-case results indicated vaccination with RZV would avert approximately 35% of HZ episodes and complications, while saving approximately 11% of net costs. Compared with no vaccination, vaccination of HCT recipients with RZV generated cost-savings (ie, lower costs and improved health) in the base case and in 81% of simulations in the probabilistic analysis. In scenario analyses, vaccination cost US dollar ($) 9500/QALY among patients with hematologic malignancies, $79 000/QALY among persons living with human immunodeficiency virus, and $208 000/QALY among persons with selected autoimmune and inflammatory conditions. Generally favorable economic estimates supported recommendations for vaccination of immunocompromised adults with RZV to prevent episodes of HZ and related complications. • In a cost-effectiveness analysis, the use of recombinant zoster vaccine (RZV) among adults aged 19 to 49 years who received a hematopoietic cell transplant was found to be cost-saving in the base-case scenario and in most sensitivity analyses. Scenario analyses investigating persons with other selected immunocompromising conditions resulted in a wide range of economic values. • Generally favorable economic estimates further support that vaccination of immunocompromised adults with RZV should be a clinical priority to prevent episodes of herpes zoster and related complications. • In October 2021, RZV (Shingrix) was recommended for use among immunocompromised adults aged ≥ 19 years. [ABSTRACT FROM AUTHOR]

• We found relatively low rates of recombinant zoster vaccine (RZV) series initiation. • There were lower rates of RZV initiation among men, those living in rural areas and in the Northeast and the South, and those of younger age. • Initiation rates differed by immune function (higher among immunocompromised). • Among initiators, overall RZV series completion was high. • This information can be used for targeting efforts to increase vaccine uptake. The Centers for Disease Control and Prevention (CDC) recommends recombinant zoster vaccination (RZV) for adults ≥ 50 years to prevent herpes zoster (HZ) and its sequelae. Initially, no distinct recommendation was made for immunocompromised adults, who experience higher HZ rates and more severe outcomes. We characterized receipt of first RZV dose (initiation) and both doses (completion) over time, and the impact of immune function on RZV uptake among adults aged 50–64 years in the United States. We identified RZV claims from the IBM MarketScan database between 1/1/2018 and 12/31/2019. We characterized immunocompromised enrollees as having malignancy, HIV, solid organ transplant, primary immunosuppression, or medication-induced immunosuppression using inpatient, outpatient, and prescription claims in the 6 months prior to study start. We evaluated patterns of vaccine uptake by demographic and healthcare access characteristics and immune status. The cumulative incidence of RZV initiation during the study period was 10.0%. Incidence increased with age and number of medical office visits, and was higher among women, urban residents, high-deductible insurance beneficiaries, and those who were immunocompromised compared to immunocompetent. Among immunocompromised adults, RZV initiation was highest among those with HIV and primary immunodeficiencies. Of those who initiated RZV, 89.5% received both doses. RZV completion was highest among those who received the first dose at a pharmacy. Most enrollees (88.6%) who completed RZV vaccination did so within the recommended dosing schedule. RZV uptake was low in the two years since the CDC recommendation, and differed by demographic, healthcare access, and clinical characteristics. Initiation rates were higher among immunocompromised adults compared to immunocompetent adults, despite no CDC recommendation for vaccination in these groups during the study period. The CDC has since recommended RZV for immunocompromised individuals, and our findings may inform efforts to increase RZV uptake in individuals at higher risk of severe disease. [ABSTRACT FROM AUTHOR]

Herpes zoster (HZ) is caused by the reactivation of the varicella zoster virus and presents with painful vesicular lesions in a dermatomal distribution. Disseminated HZ occurs when skin lesions erupt in numerous dermatomes. Upadacitinib is the first oral medication approved to treat moderate-severe Crohn's disease and has been associated with nonsevere cases of HZ. We present a case of a 60-year-old woman with refractory Crohn's disease who failed multiple immunosuppressive therapies, completed the recombinant zoster vaccines, and developed disseminated HZ on high-dose upadacitinib. She was treated with intravenous acyclovir, upadacitinib was discontinued, and was discharged on suppressive valacyclovir., (© 2025 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

The objective of this study was to critically review the cost-effectiveness (CE) of the recombinant zoster vaccine (RZV) against herpes zoster (HZ). A literature review was conducted in PubMed, Embase, and Cochrane between January 1, 2017, and February 28, 2022, and on select public healthcare agency websites to identify and collect data from CE studies comparing RZV to zoster vaccine live (ZVL) or to no vaccination. Study characteristics, inputs, and outputs were collected. The overall CE of RZV was assessed. RZV vaccination against HZ is cost-effective in 15 out of 18 studies included in the present review. Varying incremental cost-effectiveness ratios (ICERs) observed may be associated with different assumptions on the duration of protection of RZV, as well as different combinations of structural and disease-related study (model) inputs driving the estimation of ICERs.

The growing burden of herpes zoster (HZ) in Hong Kong, due to an aging population with increasing life expectancy, may be reduced by vaccination. This study aimed to estimate public health impact of HZ vaccination in Hong Kong. The ZOster ecoNomic Analysis (ZONA) model was adapted with Hong Kong-specific key model inputs/assumptions, where available. Base case analysis involved adults ≥50 years of age (YOA), exploring three vaccination strategies (no vaccination/recombinant zoster vaccine [RZV]/zoster vaccine live [ZVL]) under private market (5% coverage) and mass vaccination (40% coverage) settings. Scenario and sensitivity analyses were performed. In the base case population (3.13 million), without vaccination, 891,024 HZ (28.4%), 156,097 post-herpetic neuralgia (PHN) (5.0%), and 38,755 (1.2%) HZ ophthalmicus (HZO) were projected over their remaining lifetime. Mass RZV vaccination reduced HZ, PHN, and HZO cases by 204,875 (−23.0%), 31,949 (−20.5%), and 8,471 (−21.9%), respectively, which was 4–5 times that reduced with ZVL. RZV was more efficient than ZVL, with lower number needed to vaccinate to prevent one HZ/PHN/HZO case (RZV: 7/40/148; ZVL: 27/163/709). Among all age cohorts, the greatest reduction in cases was projected for RZV (versus no vaccination/ZVL) in the youngest cohort, 50–59 YOA. Results were robust under scenario and sensitivity analyses. HZ burden in Hong Kong is substantial. Mass RZV vaccination is expected to considerably reduce public health burden of HZ among individuals ≥50 YOA, compared with no vaccination/ZVL. Results may support value assessment and decision-making regarding vaccination strategies for HZ prevention in Hong Kong.

A candidate AS01-adjuvanted vaccine containing four surface proteins from non-typable Haemophilus influenzae and Moraxella catarrhalis (NTHi-Mcat) has been developed to help prevent exacerbations of chronic obstructive pulmonary disease (COPD). Sequential administration of different vaccines containing the same AS01-adjuvant system could lead to immune interference. We compared administration of NTHi-Mcat following AS01-adjuvanted recombinant zoster vaccine (RZV) versus NTHi-Mcat alone. This phase 2a, open-label trial (NCT03894969) randomized healthy current or former smokers (50–80 years) without COPD to administration of NTHi-Mcat at 1, 3 or 6 months after RZV or to NTHi-Mcat alone (2-dose for both vaccines). Primary outcome was non-inferiority of the humoral immune response to NTHi-Mcat administered 1 month after RZV versus NTHi-Mcat alone, evaluated by specific antibody geometric mean concentration (GMC) ratio with 95% confidence intervals (CIs). The per-protocol set included 411 participants. Primary objective was met; lower limit of the 95%CI for the GMC ratio above 0.667 for all four vaccine antigens, 1 month after the second NTHi-Mcat dose. NTHi-Mcat induced similar immune response regardless of whether administered alone or 1, 3 or 6 months following RZV. Safety and reactogenicity profiles were acceptable; adverse event frequency was similar among study groups. Injection site pain was the most common symptom. No new safety concerns were identified. The study demonstrated non-inferiority of the immune response elicited by NTHi-Mcat administered sequentially to RZV versus NTHi-Mcat alone, indicating no immune interference. Starting from 1 month, no specific interval is required between RZV and NTHi-Mcat containing the same AS01-adjuvant system components in different quantities.

A recurrent question is whether transient reactions to vaccines translate into better immune responses. Using clinical data from 2 large phase 3 studies of the recombinant zoster vaccine, we observed a small but statistically significant association between the intensity of a frequent side effect (pain) after vaccination and immune responses to vaccination. However, despite the statistical correlation, the impact on the immune response is so small, and the immune response in individuals without pain already sufficient, that pain cannot be a surrogate marker for an appropriate immune response. Reactogenicity cannot be used to predict immunity after vaccination. [ABSTRACT FROM AUTHOR]

Infection with varicella zoster virus typically occurs in children and it can cause primary varicella infection or "chickenpox", or it can reactivate later in life and cause herpes zoster or "shingles". Herpes zoster mainly occurs in older adults, causing a reduction in activities of daily living, impacting quality of life, and may lead to serious complications, including chronic pain. Two vaccines are marketed to prevent herpes zoster: the live zoster vaccine and the non-live, recombinant zoster vaccine. The pre-licensure clinical trials show the efficacy of the live zoster vaccine to be between 50 and 70% and for the recombinant vaccine to be higher at 90 to 97%. Real-world effectiveness studies, with a follow-up of approximately 10 years, were reviewed in this article. These data corroborated the efficacy studies, with vaccine effectiveness being 46% and 85% for the live and recombinant vaccines, respectively. Safety data from the effectiveness studies show similar results to the clinical trials with mostly local injection-site reactions and mild systemic reactions seen with both vaccines, although in larger proportions with the recombinant vaccine. Rare adverse events, occurring less than 1% of the time, have been seen with both vaccine types and include disseminated herpes zoster with the live zoster vaccine and Guillain–Barré syndrome with the recombinant vaccine. The wider use of preventative measures with vaccines will reduce the herpes zoster burden of illness seen in older adults. [ABSTRACT FROM AUTHOR]

In 2018, CDC recommended a highly efficacious adjuvanted recombinant zoster vaccine (RZV) as a 2-dose series for prevention of herpes zoster (HZ) for immunocompetent persons age ≥ 50 years, with the 2nd dose recommended 2–6 months after the 1st dose. We estimated second-dose RZV series completion in the U.S. among 50–64-year-olds using two administrative databases. Second-dose RZV series completion was ∼70% within 6-months and 80% within 12-months of first dose. Among those who received only 1 RZV dose with at least 12 months of follow-up time, 96% had a missed opportunity for a second-dose vaccination, defined as a provider or pharmacy visit, among whom 36% had a visit for influenza or pneumococcal vaccination within 2–12 months of their first-dose of RZV. We found that RZV series completion rates in 50–64-year-olds was high. Availability of RZV at pharmacies has potentially helped increase series completion, but missed opportunities remain. [ABSTRACT FROM AUTHOR]

Epidemiologic data regarding the risk of Guillain-Barré syndrome (GBS) following herpes zoster (HZ) are limited. We conducted a self-controlled case series analysis using two large national data sources to evaluate the risk of GBS following HZ among U.S. adults. We analyzed medical claims from the IBM® MarketScan® Commercial Claims and Encounters (persons 18–64 years during 2010–2018) and Centers for Medicare and Medicaid Services Medicare (persons ≥65 years during 2014–2018) databases. HZ cases were defined as persons with an outpatient claim with a primary or secondary ICD-9 or ICD-10 diagnostic code for HZ. GBS cases were defined as persons with an inpatient claim with a principle diagnostic code for GBS and an associated procedural code. We compared the rates of GBS following HZ in the 1–42-day risk window versus primary (100–365-day) or secondary (43–99-day) control windows. We identified 489,516 persons 18–64 years of age and 650,229 persons ≥65 years of age with HZ, among whom 11 and 41, respectively, developed GBS 1–365 days following HZ. The risk of GBS following HZ was increased during the risk window as compared to the primary control window for both groups, with a rate ratio of 6.3 (95% CI, 1.8–21.9) for those 18–64 years and 4.1 (95% CI, 1.9–8.7) for those ≥65 years. This study provides new and methodologically rigorous epidemiologic support for an association between HZ and GBS, and useful context regarding the benefits versus potential risks of zoster vaccination.

The Advisory Committee on Immunization Practices (ACIP) recommends recombinant zoster vaccine (RZV) to prevent against herpes zoster (HZ) and related complications in immunocompetent adults ≥50 y and immunocompromised adults ≥19 y. In 2019, a statistical safety signal for Guillain-Barré syndrome (GBS) following RZV was identified using data from the Vaccine Safety Datalink (VSD). Subsequently, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and collaborators undertook additional analyses using Centers for Medicare & Medicaid Services (CMS) Medicare data to further investigate the potential risk of GBS following RZV. Concurrently, epidemiologic data suggested a potentially elevated risk of GBS following HZ in U.S. adults. Using data from these sources and a published simulation model, this study evaluated the health benefits and risks associated with vaccinating immunocompetent adults ≥50 y with RZV compared to no vaccination. In the base case analysis, RZV vaccination averted 43,000–63,000 cases of HZ, including GBS complications, per million vaccinated per 10-y age cohort compared to 3–6 additional cases of GBS projected following RZV per million vaccinated in the same population. This analysis highlights the projected health benefits of RZV vaccination compared to the relatively low potential risk of GBS following RZV.

Shingrix (Recombinant zoster vaccine, RZV) was approved in October 2017 in the United States (US) for the prevention of herpes zoster in adults aged 50 years and older. The vaccine is administered in two doses, with the second dose administration recommended between two and six months after the first dose. Examination of uptake and series completion is important to ensure appropriate use, especially at the time of vaccine introduction. This report provides demographic characteristics of patients receiving RZV between October 2017 and September 2019, first- and second-dose uptake, and a cumulative estimation of second-dose completion by month for US adults aged 50 years and older. Monthly uptake increased rapidly since October 2017; overall, 7,097,441 first doses of RZV were administered along with 4,277,636 second doses during the observed timeframe. Among people with an observed first-dose administration, 70% and 80% completed the two-dose series within six and 12 months post initial dose, respectively. This evidence suggests that RZV has rapidly been adopted by a large population in the US and most are following manufacturer or policy recommendations regarding series completion. Further analyses are needed to explore potential patient, provider, and policy-relevant characteristics associated with second-dose completion that could serve as targets for further improvement.

Objective: To investigate the efficacy, effectiveness and safety of recombinant zoster vaccine (RZV) and zoster vaccine live (ZVL) in immunocompetent and immunocompromised subjects. Methods: Data sources: PubMed, EMBASE, Cochrane Library, and Web of Science databases (up to Jan 2022) were searched to identify English articles. Search terms included randomized controlled trials (RCTs), observational studies, herpes zoster, RZV, ZVL. Study Selection: Only randomized controlled trials (RCTs) evaluating vaccine efficacy and safety and observational studies assessing vaccine effectiveness (after a vaccine was approved for marketing) were included. Data Extraction: Two researchers independently screened the literature, extracted the data, and checked the each other results. Results: Seventeen RCTs and 19 cohort studies were included. Among immunocompetent subjects, RZV was superior to ZVL at wide intervals (relative vaccine efficacy: 84%, 95% CI: 53%-95%; relative vaccine effectiveness: 49%, 95% CI: 21%-67%), across genders and subjects aged = 60 years. Among immunocompromised subjects, RZV was superior to placebo in terms of vaccine efficacy (60%, 95% CI: 49%-69%). There was no difference between ZVL and placebo in those with selected immunosuppressive conditions. RZV was 45% (95% CI: 30%-59%) superior to ZVL in real-world practice. Compared with placebo, adverse events related to RZV were primarily related to injection-site and systemic, and RZV did not increase the risk of serious adverse events (SAEs) or death. There was no difference in the incidence of adverse events between groups with and without immunosuppression. Conclusions: Both RZV and ZVL can reduce the risk of herpes zoster in both immunocompetent and immunocompromised subjects. RZV was well-tolerated in the study population and demonstrated stronger protection than ZVL. [ABSTRACT FROM AUTHOR]

Increasing numbers of patients with zoster were reported recently, and recombinant zoster vaccine (Shingrix®) was licensed using the AS01B adjuvant system. Although it induces highly effective protection, a high incidence of local adverse events (regional pain, erythema, and swelling) has been reported with systemic reactions of fever, fatigue, and headache. To investigate the mechanism of local adverse events, cytokine profiles were investigated in mice injected with 0.1 mL of Shingrix®. Muscle tissue and serum samples were obtained on days 0, 1, 3, 5, and 7, and at 2 and 4 weeks after the first dose. The second dose was given 4 weeks after the first dose and samples were obtained on days 1, 3, 5, 7, and 14. IL-6 and G-CSF were detected in muscle tissues on day 1 of the first injection, decreased on day 3 and afterward, and enhanced production was demonstrated on day 1 of the second dose. In sera, the elevated levels of IL-6 were detected on day 1 of the first dose, and IL-10 was detected on day 1 with increased levels on day 3 of the first dose. IL-4 was detected in muscle tissue on day 1 of the second dose and IL-5 on day 1 of both the first and second doses. IFN-γ production was not enhanced in muscle tissue but increased in serum samples on day 1 of the first dose. These results in the mouse model indicate that the induction of inflammatory cytokines is related to the cause of adverse events in humans. [ABSTRACT FROM AUTHOR]