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The influenza vaccine administrated every year is a recommended infection control procedure for individuals above the age of six months. However, the effectiveness of repeated annual vaccination is still an active research topic. Therefore, we investigated the vaccine immunogenicity in two independent groups: previously vaccinated versus non-vaccinated individuals at three time points; prior vaccination, one week and three months post vaccination. The assessment enabled us to evaluate the elicited immune responses and the durability of the induced protection in both groups. A research study was conducted to assess the immunogenicity of a single dose of Trivalent Inactivated Influenza Vaccine (A/H1N1, A/H3N2, and B) in 278 healthy adults aged between 32 and 66 years. Almost half of the participants, 140 (50·36%), received influenza vaccination at least once precursor to past influenza seasons. One blood sample was taken prior to vaccination for complete blood analysis and baseline immunogenicity assessment. The selected study participants received a single vaccine dose on the first day, and then followed up for three months. Two blood samples were taken after one week and three months post vaccination, respectively, for vaccine immunogenicity assessment. Before vaccination, the seroprotection, defined as a hemagglutination-inhibiting titer of =>1:40, was detected for the three vaccine virus strains in 20 previously vaccinated participants (14·29%) [8·95%, 21·2%]. We compared the overall vaccine response for the three virus strains using a normalized response score calculated from linearly transformed titer measurements; the score before vaccination was 84% higher in the previously vaccinated group and the mean difference between the two groups was statistically significant. Three months post-vaccination, we didn't find a significant difference in vaccine responses; the number of fully seroprotected individuals became 48 (34·29%) [26·48%, 42·77%] in the previously vaccinated group and 59 (42·75%) [34·37%, 51·45%] in the non-vaccinated group. The calculated response score was almost equal in both groups and the mean difference was no longer statistically significant. Our findings suggest that a single dose of influenza vaccine is equally protective after three months for annually vaccinated adults and first-time vaccine receivers. [ABSTRACT FROM AUTHOR]

Neisseria meningitidis serogroup B (NmB) antigens are inherently diverse with variable expression among strains. Prediction of meningococcal B (MenB) vaccine effectiveness therefore requires an assay suitable for use against large panels of epidemiologically representative disease-causing NmB strains. Traditional serum bactericidal antibody assay using exogenous human complement (hSBA) is limited to the quantification of MenB vaccine immunogenicity on a small number of indicator strains. Additional and complementary methods for assessing strain coverage developed previously include the Meningococcal Antigen Typing System (MATS), Meningococcal Antigen Surface Expression (MEASURE) assay, and genotyping approaches, but these do not estimate vaccine effectiveness. We provide a narrative review of these methods, highlighting a more recent approach involving the hSBA assay in conjunction with expanded NmB strain panels: hSBA assay using endogenous complement in each vaccinated person's serum (enc-hSBA) against a 110-strain NmB panel and the traditional hSBA assay against 14 (4 + 10) NmB strains. The enc-hSBA is a highly standardized, robust method that can be used in clinical trials to measure the immunological effectiveness of MenB vaccines under conditions that mimic real-world settings as closely as possible, through the use of endogenous complement and a diverse, epidemiologically representative panel of NmB strains. Meningococcal disease refers to illnesses caused by the bacterium Neisseria meningitidis (meningococcus), including infections of the brain lining and spinal cord (meningitis) and bloodstream (septicemia). It is rare but often severe and can be deadly. Invasive meningococcal disease can be prevented through vaccination. Nearly all cases are caused by six serogroups (types) of meningococci, including meningococcal serogroup B. Vaccines are available against meningococcal serogroup B but, because of the uncommonness of the disease, standard clinical trials could not be performed to prove these vaccines are effective. Instead, an indirect measure, called the 'hSBA assay' (serum bactericidal antibody assay using human complement), is used to measure the ability of vaccines to provide protection against specific N. meningitidis strains that have antigens (substances that cause the immune system to react) sharing characteristics with components of the vaccines. However, meningococcal serogroup B strains are diverse in the genetic composition and expression of vaccine antigens. Hence, a large number of N. meningitidis serogroup B strains would have to be tested to make sure that the vaccine is effective against these strains. This is not feasible using the traditional hSBA assay, which requires a human complement (a protein system, which is part of the immune system) that has not come from the vaccinated person and is difficult and time-consuming to source. Recently, an alternative hSBA assay was developed that uses the complement present in each vaccinated person's blood (endogenous complement) and which overcomes these challenges. By allowing testing against a broad panel of N. meningitidis serogroup B strains, this new assay may enable a more accurate estimation of the effectiveness of vaccines against serogroup B meningococci. [ABSTRACT FROM AUTHOR]

Vaccines prevent disease and disability; save lives and represent a good assessment of health interventions. Several systematic reviews on the efficacy and effectiveness of COVID-19 vaccines have been published, but the immunogenicity and safety of these vaccines should also be addressed. This systemic investigation sought to explain the efficacy, immunogenicity, and safety of new vaccination technologies against SARS-CoV-2 in people over 18 years old. Original research studying the effectiveness on mRNA, protein subunit vaccines, and viral vector vaccines against SARS-CoV-2 in people over 18 years old was analyzed. Several databases (Web of Science, Scopus, MEDLINE and EMBASE) were searched between 2012 and November 2022 for English-language papers using text and MeSH terms related to SARS-CoV-2, mechanism, protein subunit vaccine, viral vector, and mRNA. The protocol was registered on PROSPERO, CRD42022341952. Study quality was assessed using the NICE methodology. We looked at a total of six original articles. All studies gathered and presented quantitative data. Our results suggest that new vaccinations could have more than 90% efficacy against SARS-CoV-2, regardless of the technology used. Furthermore, adverse reactions go from mild to moderate, and good immunogenicity can be observed for all vaccine types. [ABSTRACT FROM AUTHOR]

The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in significant morbidity and mortality worldwide. As SARS-CoV-2 moves into endemic status, vaccination remains a key element in protecting the health of individuals, societies, and economies worldwide. NVX-CoV2373 (Novavax, Gaithersburg, MD) is a recombinant protein vaccine composed of SARS-CoV-2 spike trimer nanoparticles formulated with saponin-based Matrix-M™ adjuvant (Novavax, Gaithersburg, MD). NVX-CoV2373 is authorized for emergency use in adults and adolescents aged ≥12 years in the United States and numerous other countries. In clinical trials, NVX-CoV2373 showed tolerable reactogenicity and favorable safety profiles characterized by mostly mild-to-moderate adverse events of short duration and by low rates of severe and serious adverse events comparable to those seen with placebo. The two-dose primary vaccination series resulted in robust increases in anti-spike protein immunoglobulin G, neutralizing antibody titers, and cellular immune responses. NVX-CoV2373 vaccination was associated with complete protection against severe disease and a high (90%) rate of protection against symptomatic disease in adults, including symptomatic disease caused by SARS-CoV-2 variants. Additionally, the NVX-CoV2373 adjuvanted recombinant protein platform offers a means to address issues of COVID-19 vaccination hesitancy and global vaccine equity. [ABSTRACT FROM AUTHOR]

Potency is a critical quality attribute for controlling quality consistency and relevant biological properties of vaccines. Owing to the high demand for animals, lengthy operations and high variability of in vivo methods, in vitro alternatives for human vaccine potency assays are extensively developed. Herein, in vivo and in vitro methods for potency assays of previously licensed human vaccines were sorted, followed by a brief description of the background for substituting in vivo methods with in vitro alternatives. Based on the analysis of current research on the substitution of vaccine potency assays, barriers and suggestions for substituting were proposed. Owing to the variability of in vivo methods, the correlation between in vivo and in vitro methods may be low. One or more in vitro method(s) that determine the vaccine antigen content and functions, should be established. Since the substitution involves with the change of critical quality attributes and specifications, the specifications of in vitro methods should be appropriately set to maintain the efficacy of vaccines. For novel vaccines in research and development, in vitro methods for monitoring the consistency and relevant biological properties, should be established based on reflecting the immunogenicity of vaccines. [ABSTRACT FROM AUTHOR]

This study evaluates the immunogenicity and reactogenicity of BNT162b2 and mRNA-1273 booster doses after the primary two-dose BNT162b2 series in Japan and is the first report from Western Pacific region. Healthcare workers receiving the two-dose BNT162b2 series and eligible for booster vaccination were enrolled. Self-reported adverse reactions were recorded for 8 days. Antibody titer was measured at baseline and on day 28. A total of 2,931 and 890 subjects received BNT162b2 (homologous) and mRNA-1273 (heterologous) booster vaccinations, respectively. The anti-SARS-CoV-2 spike protein IgG titer increased by 50.9- and 64.3-fold in the homologous and heterologous groups, respectively. Immunogenicity was greater with increasing age, regardless of sex. Adverse reactions were mild to moderate and decreased with age. The most common adverse reactions were injection-site pain (92.2%), fatigue (71.8%), headache (58.3%), and fever ≥37.5°C (46.5%). Two cases of non-severe myocarditis occurred in the heterologous group and resolved without clinical sequelae. Homologous booster schedules had fewer reported adverse reactions; heterologous boosters elicited greater immunogenicity. Among different age groups, subjects aged 60 or over had the lowest immunogenicity before the booster, and both homologous and heterologous boosters restored vaccine immunogenicity level comparable to those of younger age groups. [ABSTRACT FROM AUTHOR]

Antiretroviral therapy (ART) reduces HIV replication to undetectable levels and prevents AIDS but cannot cure the infection and discontinuing ART results in viral rebound. Therefore, a primary goal of HIV therapeutic vaccine research is to induce potent HIV-specific immunity that could control viremia without ART, a so-called "functional cure" that eliminates the need for lifelong ART. DNA vaccines have several features that make them an attractive modality for an HIV therapeutic vaccine: they are easy to manufacture, induce T-cell and antibody responses without anti-vector immunity, and do not involve ex vivo manipulations of patient cells. This review covers the progress in developing therapeutic HIV DNA vaccines, emphasizing delivery innovations to enhance vaccine immunogenicity. A central theme is a transition from needle injection delivery to the muscle toward using more sophisticated devices to target the skin and/or increasing transfection efficiency. There are multiple barriers to an effective therapeutic HIV DNA vaccine. While variables such as delivery, adjuvants, and immunogen design have been extensively explored, combining DNA vaccines with complementary approaches is underdeveloped. Complementary approaches include co-administration with latency reversal agents, immune checkpoint blockade, and targeting conserved fitness-constrained portions of the virus. [ABSTRACT FROM AUTHOR]

Recombinant surface protein meningococcal serogroup B (MenB) vaccines are available but with different antigen compositions, leading to differences between vaccines in their immunogenicity and likely breadth of coverage. The serology and breadth of coverage assessment for MenB vaccines are multifaceted areas, and a comprehensive understanding of these complexities is required to appropriately compare licensed vaccines and those under development. In the first of two companion papers that comprehensively review the serology and breadth of coverage assessment for MenB vaccines, the history of early meningococcal vaccines is considered in this narrative review to identify transferable lessons applicable to the currently licensed MenB vaccines and those under development, as well as their serology. Understanding correlates of protection and the breadth of coverage assessment for meningococcal surface protein vaccines is significantly more complex than that for capsular polysaccharide vaccines. Determination and understanding of the breadth of coverage of surface protein vaccines are clinically important and unique to each vaccine formulation. It is essential to estimate the proportion of MenB cases that are preventable by a specific vaccine to assess its overall potential impact and to compare the benefits and limitations of different vaccines in preventing invasive meningococcal disease. [ABSTRACT FROM AUTHOR]

Introduction: Vaxigrip, a trivalent split-virion, inactivated vaccine available since 1968 has been in use longer than any other influenza vaccine. It is the most widely-used influenza vaccine, with more than 1.8 billion doses distributed in more than 120 countries. Areas covered: The significant body of evidence that confirms the efficacy, effectiveness, immunogenicity, and safety of Vaxigrip in healthy individuals of all ages and at-risk populations is summarized. The results from at least 15 randomized efficacy trials and 15 other studies have demonstrated that vaccination with Vaxigrip is efficacious against various clinical endpoints. It was estimated that more than 37 million laboratory-confirmed influenza episodes, 476,000 influenza-related hospitalizations, and 67,000 influenza-related deaths have been avoided by the more than 1.8 billion doses of Vaxigrip that have been distributed, emphasizing its important public health impact. Expert commentary: This strong evidence base in favor of Vaxigrip provides a robust foundation to support the implementation of the quadrivalent formulation. This quadrivalent formulation of Vaxigrip contains two A and two B influenza strains (VaxigripTetra), and has a similar immunogenicity and safety profile to the trivalent formulation while offering broader protection due to the addition of the second influenza B strain.

Introduction: Vaxigrip, a trivalent split-virion, inactivated vaccine available since 1968 has been in use longer than any other influenza vaccine. It is the most widely-used influenza vaccine, with more than 1.8 billion doses distributed in more than 120 countries. Areas covered: The significant body of evidence that confirms the efficacy, effectiveness, immunogenicity, and safety of Vaxigrip in healthy individuals of all ages and at-risk populations is summarized. The results from at least 15 randomized efficacy trials and 15 other studies have demonstrated that vaccination with Vaxigrip is efficacious against various clinical endpoints. It was estimated that more than 37 million laboratory-confirmed influenza episodes, 476,000 influenza-related hospitalizations, and 67,000 influenza-related deaths have been avoided by the more than 1.8 billion doses of Vaxigrip that have been distributed, emphasizing its important public health impact. Expert commentary: This strong evidence base in favor of Vaxigrip provides a robust foundation to support the implementation of the quadrivalent formulation. This quadrivalent formulation of Vaxigrip contains two A and two B influenza strains (VaxigripTetra), and has a similar immunogenicity and safety profile to the trivalent formulation while offering broader protection due to the addition of the second influenza B strain. [ABSTRACT FROM PUBLISHER]

Dengue is caused by four serotype-distinct dengue viruses (DENVs), and developing a multivalent vaccine against dengue has not been straightforward since partial immunity to DENV may predispose to more severe disease upon subsequent DENV infection. The vaccine that is furthest along in development is CYD™, a live attenuated tetravalent vaccine (LATV) produced by Sanofi Pasteur. Although the multi-dose vaccine demonstrated protection against severe dengue, its overall efficacy was limited by DENV serotype, serostatus at vaccination, region and age. The National Institute of Allergy and Infectious Diseases has developed the LATV dengue vaccines TV003/TV005. A single dose of either TV003 or TV005 induced seroconversion to four DENV serotypes in 74–92% (TV003) and 90% (TV005) of flavivirus seronegative adults and elicited near-sterilizing immunity to a second dose of vaccine administered 6–12 months later. The important differences in the structure, infectivity and immune responses to TV003/TV005 are compared with CYD™. [ABSTRACT FROM PUBLISHER]