Vaccine最新文献

{"title":"Designing sero-epidemiological studies to explore immune markers associated with a reduced risk of invasive Klebsiella pneumoniae disease.","authors":"Ziyaad Dangor, Ruchita Balasubramanian, Alane Izu, Courtney Olwagen, Kirsty Le Doare, James A Berkley, David Goldblatt, Nicole Benson, Padmini Srikantiah, Shabir A Madhi","doi":"10.1016/j.vaccine.2026.129260","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.129260","url":null,"abstract":"<p><p>Klebsiella pneumoniae (Kpn) is a leading cause of neonatal invasive bacterial disease especially in low- and middle-income countries (LMICs), with 20-30% of culture-confirmed neonatal sepsis caused by Kpn. This, coupled with the rapid emergence of multidrug-resistant strains, calls for additional therapeutic options. Maternal vaccination represents a promising strategy to confer protection to neonates through transplacental transfer of antibodies, with modelling suggesting a vaccine of moderate efficacy (~70%) could avert over 80,000 neonatal deaths annually. Advancing Kpn vaccine development requires identification and validation of serological thresholds of risk reduction (SToRR), or immune markers associated with a reduced risk of invasive Kpn disease (IKpnD). However, no standardized framework currently exists for this purpose. Drawing on lessons from other pathogens, this review outlines key methodological considerations for designing rigorous sero-epidemiological studies to establish such markers. We address three critical domains: (i) study design and population selection, including the rationale for nested case-control designs within birth cohorts enriched for high-risk neonates; (ii) statistical approaches for threshold estimation, including covariate-adjusted logistic regression and Bayesian frameworks; and (iii) laboratory standardization and assay validation, encompassing binding and functional antibody assays. Addressing these considerations systematically will accelerate the development and deployment of a Kpn vaccine capable of reducing neonatal mortality globally.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"94 ","pages":"129260"},"PeriodicalIF":3.5,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149225709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AEX-1: A Vero cell variant with enhanced permissiveness for influenza virus replication.","authors":"Artem Krokhin, Julia Romanova, Regina Grillari, Matthias Hackl, Pavel Korabliov, Jozef Mandík, Andrej Egorov","doi":"10.1016/j.vaccine.2026.129237","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.129237","url":null,"abstract":"<p><strong>Background: </strong>Continuous cell substrates with improved permissiveness for influenza virus replication are of considerable interest for vaccine development and manufacturing. Vero cells have an excellent regulatory track record; however, their relatively low influenza virus productivity limits their broader application.</p><p><strong>Methods: </strong>We developed the AEX-1 cell line by co-cultivating Vero cells with chicken embryo amniotic membrane fragments. Cellular morphology, intracellular acidification, influenza virus replication, transcriptomic profile, genetic stability, and tumorigenicity were evaluated.</p><p><strong>Results: </strong>AEX-1 cells displayed distinct morphology and enhanced endosomal/lysosomal acidification compared with parental Vero cells. At 72 h post-infection, a commonly used harvest time for influenza vaccine virus production, AEX-1 cells produced higher infectious titres of WHO-recommended egg-derived A/Sydney/5/2021 (H1N1)pdm09-like and B/Austria/1359417/2021 vaccine viruses, with titres approaching those obtained in embryonated chicken eggs and exceeding Vero cell yields by 0.9-1.7 log₁₀ EID₅₀/ml. No replication advantage was observed for the egg-derived A/Croatia/10136RV/2023 (H3N2) vaccine virus, carrying the egg-adaptive HA G53D substitution, or for the egg-derived A/duck/Vietnam/NCVD-1584/2012 (H5N1) vaccine strain. However, the A/Darwin/9/2021-like Vero-derived primary isolate A/Austria/1516645/2022 (H3N2), lacking G53D, reached infectious titres up to 3.0 log₁₀ TCID₅₀/ml higher than in Vero and 2.3 log₁₀ TCID₅₀/ml higher than in MDCK cells. H1N1 UniFluVec-based influenza virus vectors also replicated efficiently in AEX-1 cells. Transcriptomic analysis revealed changes in genes involved in proton transport, vesicular acidification, and intracellular pH regulation. AEX-1 remained genetically stable after prolonged passaging and showed no evidence of increased tumorigenicity in vitro or in vivo.</p><p><strong>Conclusions: </strong>Enhanced intracellular acidification may contribute to improved influenza virus replication in AEX-1 cells, suggesting that modulation of endosomal acidification may provide a rational strategy for developing improved cell substrates for influenza vaccine production.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"94 ","pages":"129237"},"PeriodicalIF":3.5,"publicationDate":"2026-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149221280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to \"The case for model-informed vaccine development\" [Vaccine 92 (2026) 128780].","authors":"Jane P F Bai, Fatemeh Beigmohammadi, Morgan Craig, Mackenzie Dalton, Rajat Desikan, Terry Easlick, Sonia Gazeau, Jane Heffernan, Anna Kirpichnikova, Pranesh Padmanabhan, Jeffrey R Sachs, Anna Sher, David Skibinski, Amber M Smith","doi":"10.1016/j.vaccine.2026.129245","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.129245","url":null,"abstract":"","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":" ","pages":"129245"},"PeriodicalIF":3.5,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149198679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"rVSV-ΔG-EBOV-GP-Nipah-G (also designated PHV02) replication-competent, recombinant vesicular stomatitis virus vaccine for prevention of Nipah virus disease: Standardized template with key considerations for a risk/benefit assessment.","authors":"Thomas P Monath, Joan Fusco, Emily Erbelding, Tracy Kemp, D Gray Heppner, Michele DeVries, Richard Nichols, Joseph D Crowell, Kelly Scappaticci, Thaddeus G Pullano, Heinz Feldmann, Friederike Feldmann, Emily R Wellman, Eileen C Farnon, Robert T Chen, Shelly Karuna","doi":"10.1016/j.vaccine.2026.129113","DOIUrl":"https://doi.org/10.1016/j.vaccine.2026.129113","url":null,"abstract":"<p><p>A recombinant vesicular stomatitis virus (rVSV) expressing the glycoprotein (GP) of Ebola virus (rVSV-EBOV GP) has been approved for preventive immunization against Ebola (Ervebo®, Merck & Co.). The rVSV-EBOV vector was modified to express an additional glycoprotein (G) of Nipah virus (NiV), a bat-borne henipavirus endemic/epidemic in South and Southeast Asia that causes fatal encephalitis and pneumonia. The rVSV-EBOV-GP-NiV G vaccine candidate (\"PHV02\") is a unique chimeric virus with tropism and immunological properties derived from the wild-type (wt) vesicular stomatitis virus (VSV) parent, the rVSV-EBOV-GP vector and the NiV G transgene donor. The EBOV GP enables fusion with the cell membrane and virus entry, whereas the NiV G protein mediates attachment to cells and serves as the antigen for stimulating NiV-specific immunity. This review focuses on the characteristics of the vector and vaccine candidate relevant to clinical and environmental safety, immunogenicity and efficacy. The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) standardized template is used to update the key characteristics and risks of the rVSV-EBOV vector (previously published [1]) and the novel PHV02 NiV vaccine candidate which is now in clinical trials. The template provides a rich source of information and guide to the supporting literature. While analogies of the PHV02 NiV vaccine to the backbone rVSV-EBOV vector are useful given the more extensive data available on the vector, the template emphasizes that PHV02 is a novel construct from a regulatory perspective and targets a different disease with unique characteristics and pathogenesis. Where similarities and parallels are drawn between nonclinical and clinical outcomes of rVSV-EBOV (vector) and PHV02 (vaccine), the reader should be cognizant of the limitations of these conclusions. The intended use of the standardized template is to provide a cohesive reference allowing vaccine developers and regulatory reviewers to understand characteristics, benefits and risks of a new vaccine candidate against NiV relevant to its future use in human populations, and to compare and contrast these characteristics to an approved vaccine constructed from the same (rVSV) vector system against a different indication (ebolavirus). The systematized template structure should facilitate utility of the paper.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":" ","pages":"129113"},"PeriodicalIF":3.5,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149186353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum to \"Partner awareness and support for maternal RSV vaccination: a paired survey of pregnant women and co-residing partners in Japan\" [Vaccine 88 (2026) 128946].","authors":"Aya Saitoh, Mayumi Takaku","doi":"10.1016/j.vaccine.2026.128966","DOIUrl":"10.1016/j.vaccine.2026.128966","url":null,"abstract":"","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":" ","pages":"128966"},"PeriodicalIF":3.5,"publicationDate":"2026-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148611627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-effectiveness of free influenza vaccination policy for Chinese older adults: a modeling analysis using real-world data.","authors":"Xiaoqing Wu, Yumin Tao, Yexiang Sun, Jieping Chen, Mengqian Lv, Tianchi Yang, Lixia Ye","doi":"10.1016/j.vaccine.2026.128782","DOIUrl":"10.1016/j.vaccine.2026.128782","url":null,"abstract":"<p><strong>Objective: </strong>Vaccination serves as the most efficacious intervention to prevent influenza-related illness. The aim of this study was to compare the lifetime cost-effectiveness of a fully-funded trivalent inactivated influenza vaccine (TIV) strategy for people aged 60 years and over.</p><p><strong>Methods: </strong>A static decision-tree Markov model was employed to conduct a lifetime economic evaluation from a societal perspective. Model parameters such as probabilities, costs and utility values, were derived from regional health information platform, published literature, and investigation. The number of cases and deaths averted, quality-adjusted life years (QALYs) gained, and the incremental cost-effectiveness ratio (ICER) were predicted. Sensitivity analyses were performed to evaluate the uncertainty of results.</p><p><strong>Results: </strong>Compared with self-paid vaccination, the implementation of the free influenza vaccination program is projected to cumulatively reduce 261,374 non-medically attended influenza cases,370,155 outpatient influenza cases, 13,678 hospitalized influenza cases, and 1987 influenza-associated deaths. It is estimated that this programme will generate cumulative cost savings of $2,184,312 and an additional 14,324 QALYs, rendering it a dominant strategy. At a willingness-to-pay (WTP) threshold of one times of the per capita gross domestic product (GDP) of Ningbo, the probability of the programme being cost-effective is 99.88%. The threshold analysis revealed that the threshold price of TIV is $11.18 under the most conservative WTP threshold.</p><p><strong>Conclusions: </strong>It has been demonstrated that the free influenza vaccination policy are cost-effective for the elderly individuals. The government and health authorities are supposed to implement and promote a universal free influenza vaccination programme for the elderly, with particular emphasis on the oldest age groups.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"88 ","pages":"128782"},"PeriodicalIF":3.5,"publicationDate":"2026-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148177521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retraction notice to \"Effectiveness of prescription-based influenza vaccination services among older adults in Binzhou, China: A cluster-randomized controlled trial\" [Vaccine 82 (2026) 128588].","authors":"Lin Zhang, Tao Lin, Mengjie Wang, Xiaohui Ma, Huijuan Dong, Jintong Song, Yang Li","doi":"10.1016/j.vaccine.2026.128885","DOIUrl":"10.1016/j.vaccine.2026.128885","url":null,"abstract":"","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":" ","pages":"128885"},"PeriodicalIF":3.5,"publicationDate":"2026-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148400211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acute intraocular inflammation: Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data.","authors":"Steven Yeh, Wanjiku Mathenge, Jean-Claude Mwanza, Supriya Shetty, Alice Taylor, Timothy Kaftan, Hammad Ali, Barbara Law","doi":"10.1016/j.vaccine.2026.128919","DOIUrl":"10.1016/j.vaccine.2026.128919","url":null,"abstract":"<p><p>This is a new Brighton Collaboration (BC) case definition of acute intraocular inflammation (aIOI) which includes one or more of: anterior uveitis, intermediate uveitis, posterior uveitis, panuveitis, retinal vasculitis, and neuroretinitis. It is intended for use in vaccine safety studies including clinical trials throughout the vaccine life cycle, background incidence studies, causality assessment hypothesis testing studies and post-licensure pharmacovigilance activities to facilitate safety data comparability across multiple settings. It is not intended to guide clinical management. The case definition was developed by a group of subject matter and BC process experts as part of the Coalition for Epidemic Preparedness Innovations (CEPI) funded Safety Platform for Evaluation of vACcines (SPEAC). The BC case definition includes a scoping review of literature and expert consensus used to define levels of diagnostic certainty for aIOI and provide specific guidelines for related data collection and analysis. The document underwent peer review by vaccine safety stakeholders to ensure case definition usability and applicability as well as aIOI experts for scientific integrity.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":" ","pages":"128919"},"PeriodicalIF":3.5,"publicationDate":"2026-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148551938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-time in-season monitoring of adult influenza vaccination coverage rates in Germany: results from a repeated cross-sectional online survey.","authors":"Andreas Bietz, Petra Sandow, Christina Hartmann, Leonie Steffan, Benedict Katzenberger, Oliver Damm, Marie Dietzsch, Christine Hagemann","doi":"10.1016/j.vaccine.2026.128765","DOIUrl":"10.1016/j.vaccine.2026.128765","url":null,"abstract":"<p><strong>Objective: </strong>Proof of concept to provide early estimates of influenza vaccination coverage rates (VCR) for adults in Germany during the 2024/25 season, explore variation across recommended risk groups, and identify reasons for/against vaccination.</p><p><strong>Methods: </strong>A web-based, repeated cross-sectional survey (Vakzimeter FLU) was conducted in five waves between October-2024 and February-2025 in Germany. Disproportionate sampling ensured adequate representation of adults aged ≥60 years; general population estimates were obtained after calibrated weighting to align the sample with national demographics. Respondents reported past and current influenza vaccination status, intention to get vaccinated, socio-demographics, chronic conditions, occupational and household risk factors, and reasons for/against getting vaccinated against influenza.</p><p><strong>Results: </strong>Among 5001 respondents (18-59 years, n = 1505; ≥60 years, n = 3496), VCR during survey wave 5 (February-2025) was 26% for adults aged 18-59 years overall, 32% for at-risk adults aged 18-59 years, and 51% for adults aged ≥60 years. Weighted estimate VCR of general population was 36%. All values were below the WHO target of 75% for risk groups. Although each survey wave included a separate set of participants, vaccination status patterns may hint towards older adults being more likely to follow through with intended vaccination, while younger adults may be more likely not to. Key reasons against vaccination included low perceived risk, belief that influenza is not severe, and concerns over vaccine effectiveness/safety. In the 18-59 age group, 46% indicated no vaccination in the current season and had not received an influenza vaccination for ≥5 consecutive seasons, reflecting persistent hesitancy.</p><p><strong>Conclusion: </strong>This real-time monitoring approach provided timely, population-representative influenza VCR estimates during the influenza season, enabling in-season gap identification. Findings confirm persistent shortfalls in VCRs, particularly among younger adults, and reinforce the need for tailored, trust-building strategies to both convert stated intent into actual vaccination and boost initial willingness, especially in at-risk groups.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"88 ","pages":"128765"},"PeriodicalIF":3.5,"publicationDate":"2026-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148177515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment on \"Effect of pneumococcal conjugate vaccine booster dose on prevention of invasive pneumococcal disease in British Columbia, 2003-2018\".","authors":"Bhumesh Tyagi, Leelabati Toppo, Aishwarya Biradar","doi":"10.1016/j.vaccine.2026.128925","DOIUrl":"10.1016/j.vaccine.2026.128925","url":null,"abstract":"","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"88 ","pages":"128925"},"PeriodicalIF":3.5,"publicationDate":"2026-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148439873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}