Vaccine最新文献

{"title":"SARS-CoV-2 vaccine failure rates and predictors of immune response in a diverse immunocompromised patient population","authors":"Benjamin M. Greenberg ,&nbsp;John D. Minna ,&nbsp;David E. Gerber ,&nbsp;Roberto S. Hernandez ,&nbsp;Nancy Monson ,&nbsp;Alagarraju Muthukumar ,&nbsp;Kaniel Cassady ,&nbsp;Erica Chio ,&nbsp;Andrea T. Hooper ,&nbsp;Matthew F. Wipperman ,&nbsp;David E. Greenberg","doi":"10.1016/j.vaccine.2025.127473","DOIUrl":"10.1016/j.vaccine.2025.127473","url":null,"abstract":"<div><h3>Background</h3><div>Determining individual responses to vaccination is critical for effective prevention of SARS-CoV-2 infection, particularly in populations at risk of vaccine failure.</div></div><div><h3>Methods</h3><div>In this prospective study, we collected serum specimens prior to the first and post-second and -third vaccinations to examine the quantity, quality, and durability of immune responses to SARS-CoV-2 vaccination in patients receiving various immune-modulating therapies. To determine rates of vaccine failure, we measured SARS-CoV-2 anti-spike protein immunoglobulin G and neutralisation titres.</div></div><div><h3>Findings</h3><div>We analysed post-vaccination serum samples from 293 potentially immunocompromised patients (10·2 % haematologic malignancies, 56·0 % solid tumours, 27·6 % neuroimmunological conditions, and 6·1 % other). Based on IgG titres, 22·4 % and 12·0 % of cases were deemed vaccine failures by serology within 6 months of the second and third COVID-19 vaccinations, respectively; these rates were 32·7 % and 13·9 %, respectively, based on neutralisation. Notably, 12·2 % of samples did not have functional neutralising antibodies despite positive serology (mismatched result) within 6 months of the second COVID-19 vaccine dose. The highest rate of vaccine failure occurred in patients receiving active B-cell depleting therapies (primarily haematological malignancies or neuroimmunological conditions); those receiving cytotoxic chemotherapy or immune checkpoint inhibitors (predominantly patients with solid tumours) were at the lowest risk for vaccine failure.</div></div><div><h3>Interpretation</h3><div>Among patients receiving potentially immunosuppressive therapies, individuals treated with B-cell depletion therapies have high risk for vaccine failure after COVID-19 vaccination, but the rate of failure declines significantly with subsequent doses. In these populations, positive serology tests alone may not signify a protective immune response.</div></div><div><h3>Funding</h3><div>Supported by a grant from Regeneron Pharmaceuticals, Inc., and P54 CA260560.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127473"},"PeriodicalIF":4.5,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144605193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An England-wide survey on attitudes towards antenatal and infant immunisation against respiratory syncytial virus amongst pregnant and post-partum women","authors":"Jonathan Broad,&nbsp;Louise Letley,&nbsp;Georgie Adair,&nbsp;Jemma Walker,&nbsp;Tami Benzaken,&nbsp;Vanessa Saliba,&nbsp;Mary E. Ramsay,&nbsp;Conall H. Watson ,&nbsp;Helen Campbell","doi":"10.1016/j.vaccine.2025.127482","DOIUrl":"10.1016/j.vaccine.2025.127482","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory syncytial virus (RSV) causes significant morbidity. New immunisations to protect infants have been licensed in the UK including a vaccine in pregnancy and a monoclonal antibody injection in infants. The UK Joint Committee on Vaccination and Immunisation has advised that either could be considered suitable for a national programme. We conducted a survey of pregnant women to understand acceptability and barriers to RSV immunisation.</div></div><div><h3>Methods</h3><div>73,734 women were emailed a Health Security Agency survey on decision making around maternal and baby health via a parent support organisation. The survey collected baseline demographics, expressed likelihood of accepting maternal vaccine or immunisation for their infant, and perceptions of potential barriers, using likert scales and free text questions. Eligibility criteria were: pregnant or with a child up to 6 months of age, living in England, 18 years or older. Responses were quantified descriptively; binary logistic regression was used to measure multivariable associations; thematic analysis was conducted on qualitative data.</div></div><div><h3>Results</h3><div>1061 women completed the survey. Respondents were likely to accept maternal RSV vaccination (89.5 %, 95 % CI 87.5–91.3) or infant immunisation (81.4 %, 95 % CI 79.0–83.7). Multivariable analysis showed higher acceptability was associated with having a partner and possible association with ethnicity. No difference was observed by deprivation, or disability status on multivariable analysis. Participants most trusted midwives for information.</div></div><div><h3>Conclusion</h3><div>Maternal and infant RSV immunisations were both highly acceptable, supporting the roll out of either programme. Ongoing monitoring will support evaluation of programme implementation and equity of access.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127482"},"PeriodicalIF":4.5,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144605218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pertussis antibody responses in infants born to mothers vaccinated at different time points in pregnancy","authors":"Olwenn Daniel ,&nbsp;Sashank Srikanth ,&nbsp;Paul Clarke ,&nbsp;Kirsty Le Doare ,&nbsp;Paul T. Heath ,&nbsp;Christine E. Jones ,&nbsp;Tim Scorrer ,&nbsp;Matthew Snape ,&nbsp;Anna Calvert","doi":"10.1016/j.vaccine.2025.127481","DOIUrl":"10.1016/j.vaccine.2025.127481","url":null,"abstract":"<div><div>The optimal timing of pertussis vaccination in pregnancy is debated, especially to maximise antibody concentrations in infants born preterm. This study investigated immunoglobulin G (IgG) in preterm infants at 5 and 12 months, whose mothers had received a pertussis-containing vaccine at different gestations or were unvaccinated. Results show that vaccination in the early-mid second trimester may result in increased FHA specific IgG concentrations in preterm infants at 5 and 12 months.</div><div>The BEAR PAW study used residual serum samples from the BEAR Men B study (Babies born Early Antibody Response to Men B vaccination (<span><span>NCT03125616</span><svg><path></path></svg></span>)).</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127481"},"PeriodicalIF":4.5,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144605191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sociodemographic and socioeconomic disparities in pediatric influenza vaccination: A cohort study from the pedianet network","authors":"Rigamonti Vera ,&nbsp;Rosato Isabella ,&nbsp;Costanza Di Chiara ,&nbsp;Cantarutti Anna ,&nbsp;Canova Cristina","doi":"10.1016/j.vaccine.2025.127494","DOIUrl":"10.1016/j.vaccine.2025.127494","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate the sociodemographic and socioeconomic factors impacting pediatric influenza vaccination coverage in Italy.</div></div><div><h3>Study design</h3><div>This retrospective observational cohort study included all children aged 6 months to 14 years at the start of the five consecutive seasons (September 1, 2019, to January 31, 2024) who were enrolled in the Pedianet network, a comprehensive database comprising over 200 family pediatricians in Italy. Generalized linear mixed-effects models were used to analyze the association between children's sex, age group (6 months-6 years, 7–11 years, 12–14 years), sibling status, area of birth, Area Deprivation Index (ADI), presence of comorbidities, and vaccination coverage across seasons.</div></div><div><h3>Results</h3><div>Influenza vaccination coverage remained suboptimal across all seasons considered, with a minimum of 7 % in 2019/2020 and a peak of 12 % during the 2020/2021 season. The likelihood of vaccination decreased with increasing age, while children with at least one sibling and those residing in Central or Southern Italy and the Islands were more likely to be vaccinated. Beginning with the 2020/2021 season, our results demonstrate a significantly lower likelihood of vaccination among children from more deprived areas. No significant differences were observed between males and females.</div></div><div><h3>Conclusion</h3><div>Our findings enhance the understanding of the sociodemographic factors influencing influenza vaccination coverage among Italian children. Considering the role and complexity of these determinants is essential for developing tailored vaccination strategies to improve coverage in the future.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127494"},"PeriodicalIF":4.5,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144605194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Changes in pneumococcal vaccination disparities by area-level social vulnerability during the COVID-19 pandemic among Medicare and Medicaid enrollees","authors":"Salini Mohanty ,&nbsp;Jelena Zurovac ,&nbsp;Michael Barna ,&nbsp;Nicole Cossrow ,&nbsp;Peter C. Fiduccia ,&nbsp;Kelsie Cassell ,&nbsp;Esther Smith-Howell ,&nbsp;Valina C. McGuinn ,&nbsp;Saumya Chatrath ,&nbsp;Priya Shanmugam ,&nbsp;Aparna Keshaviah ,&nbsp;Dmitriy Poznyak ,&nbsp;Alyssa Evans ,&nbsp;Kristen A. Feemster","doi":"10.1016/j.vaccine.2025.127452","DOIUrl":"10.1016/j.vaccine.2025.127452","url":null,"abstract":"<div><h3>Background</h3><div>The COVID-19 pandemic amplified long-standing health disparities in the United States and spurred new research into factors associated with vaccine uptake. While much of the focus has been on COVID-19 vaccines, few studies have examined disparities in pneumococcal vaccination.</div></div><div><h3>Methods</h3><div>Using a retrospective cohort design, we assessed how disparities in county-level pneumococcal vaccination rates by social vulnerability level changed across two periods: before COVID-19 (Medicare: 2016–2019; Medicaid: 2017–2019) and during COVID-19 (2020−2022). Vaccination data were derived from the claims of adult Medicare enrollees (aged ≥65 years) and Medicaid enrollees (aged 19–64), whereas social vulnerability was measured using the Minority Health Social Vulnerability Index. We analyzed changes in vaccine uptake disparities using a difference-in-differences regression model adjusted for demographics and clinical factors.</div></div><div><h3>Findings</h3><div>Both before and during COVID-19, vaccination rates were lower among enrollees residing in high-vulnerability counties. During the pandemic, disparities in pneumococcal vaccination rates decreased among the 37.5 million Medicare enrollees analyzed but increased among the 8.1 million Medicaid enrollees. These patterns remained even after adjusting for enrollee demographic and clinical characteristics.</div></div><div><h3>Interpretation</h3><div>During COVID-19, Medicare enrollees exhibited reduced disparities in pneumococcal vaccination, possibly due to heightened risk perception, whereas Medicaid enrollees experienced widening gaps, likely driven by socioeconomic barriers. These findings highlight the complex interplay of individual demographic and clinical characteristics, and area-level social vulnerability in shaping vaccine uptake. To improve public health, initiatives should consider these multifaceted factors to effectively address disparities.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127452"},"PeriodicalIF":4.5,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144613388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a live-attenuated vaccine challenge model of Yersinia pestis in humans: Expert consultation on clinical trial considerations, January 2025","authors":"Anna Rydlova ,&nbsp;Emma Smith ,&nbsp;Arabella Stuart ,&nbsp;Robin Shattock ,&nbsp;Tim Brooks ,&nbsp;Thomas C. Darton ,&nbsp;Maria Piggin ,&nbsp;Ryan O'Hare ,&nbsp;Al McCartney ,&nbsp;Megan E. Carey ,&nbsp;Malick M. Gibani","doi":"10.1016/j.vaccine.2025.127492","DOIUrl":"10.1016/j.vaccine.2025.127492","url":null,"abstract":"<div><div><em>Yersinia pestis</em> is the causative agent of plague – the archetypal bacterial pandemic disease. Plague remains endemic in several countries in Africa, South America, and Asia, posing high risks of zoonotic spill-over and epidemic spread or threat of deliberate release. Plague vaccine development remains a priority for pandemic preparedness initiatives but generating sufficient field data for vaccine licensure is challenging.</div><div>Controlled human infection studies have been deployed to test candidate vaccines against diseases with low and sporadic incidences of outbreaks where field trials are difficult. Typically, such studies use live attenuated or vaccine-type strains to measure clinical or microbiological end points of interest. To assess the feasibility of conducting a human vaccine-challenge study for <em>Y. pestis</em>, we hosted a one-day expert consultation workshop in January 2025. The aim was to discuss the practical, regulatory landscape and future use-case of such a model. We invited attendees from academia, industry, regulatory bodies, funders, and other stakeholders with expertise in <em>Y. pestis</em> biology and infection. The workshop combined presentations with breakout discussions and was divided into five sessions: i) Introduction to live attenuated <em>Y. pestis</em> vaccines; ii) Update of the contemporary plague vaccine landscape; iii) Assessment of biosafety and bio-security considerations; iv) Clinical and ethical considerations and v) public perceptions. Several challenges were identified, and potential strategies to address them were discussed.</div><div>This perspective builds on this workshop and lays the foundation for a collaborative consortium to develop a <em>Y. pestis</em> vaccine challenge model. Next steps include early-stage public engagement, strain characterization, and regulatory discussions to define how data from these studies could be used for assessing vaccine efficacy. Our vision is to establish a global network dedicated to advancing new vaccine technologies for an ancient disease.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127492"},"PeriodicalIF":4.5,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144605249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “Correlates of COVID-19 vaccine coverage in Arkansas: Results from a weighted random sample survey” [Vaccine 41(41) (2023) 6120–6126]","authors":"Don E. Willis ,&nbsp;Ramey Moore ,&nbsp;Jennifer A. Andersen ,&nbsp;Ji Li ,&nbsp;James P. Selig ,&nbsp;Joshua C. McKinnon ,&nbsp;Morgan Gurel-Headley ,&nbsp;Sharon Reece ,&nbsp;Pearl A. McElfish","doi":"10.1016/j.vaccine.2025.127485","DOIUrl":"10.1016/j.vaccine.2025.127485","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127485"},"PeriodicalIF":4.5,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144605220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Change in herpes zoster vaccination uptake before and during the COVID-19 pandemic in the United States older adults","authors":"Jialing Lin ,&nbsp;Zhaoli Dai ,&nbsp;Chenxi Li ,&nbsp;Wen-Qiang He","doi":"10.1016/j.vaccine.2025.127503","DOIUrl":"10.1016/j.vaccine.2025.127503","url":null,"abstract":"<div><h3>Objectives</h3><div>To examine changes in herpes zoster (HZ) vaccination uptake among older adults in the United States before and during the COVID-19 pandemic and related factors.</div></div><div><h3>Methods</h3><div>We estimated HZ vaccination uptake before (2018–2019) and during (2020−2022) the COVID-19 pandemic among adults aged ≥50 years using the National Health Interview Survey data. We used log-binomial regression to examine uptake changes with adjustment for and stratification by sociodemographic and health characteristics.</div></div><div><h3>Results</h3><div>Among 79,786 adults (mean age: 66.4 years; male: 55.6 %), the uptake prevalence increased from 25.1 % before the pandemic to 30.1 % during the pandemic, with a 1.36-fold increase in prevalence (adjusted prevalence ratio: 1.36 [95 % CI: 1.30–1.41]). Such increase was observed across all subgroups, with more prominent increases among adults aged 50–64 years, men, non-Hispanic Black and other ethnicity, those with low household income, from West regions, living with partners, current smokers, received prior flu vaccinations, and those without comorbidities. Despite these increases, the uptake during the pandemic remained significantly lower in these subgroups compared to others.</div></div><div><h3>Conclusions</h3><div>Although HZ vaccination uptake among older adults increased during the COVID-19 pandemic compared to before the pandemic, and this increase was more prominent among ethnic minorities, low-income, and obese and smoker groups, uptake remains suboptimal. With the ageing population, ongoing monitoring and better strategies are required to ensure uptake continues to increase.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127503"},"PeriodicalIF":4.5,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144605219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Engaging trusted messengers in public health response: Key strategies to building community trust among CDC'S prevention research center's vaccine confidence network","authors":"Emily Stiehl ,&nbsp;Amy Borg ,&nbsp;John P. Cullen ,&nbsp;AnaÏs Mendiola ,&nbsp;Olivia Dominguez ,&nbsp;Danielle Pester ,&nbsp;Shan Qiao ,&nbsp;Pooja Gandhi ,&nbsp;Nicole Kuiper ,&nbsp;Princilla Minkah ,&nbsp;Shekwonya Samuel ,&nbsp;Stephen Flores ,&nbsp;Richard Quartarone ,&nbsp;Grace W. Ryan ,&nbsp;Paula Cuccaro ,&nbsp;Maria E. Fernández ,&nbsp;Sage Kim","doi":"10.1016/j.vaccine.2025.127474","DOIUrl":"10.1016/j.vaccine.2025.127474","url":null,"abstract":"<div><div>As part of Centers for Disease Control and Prevention's (CDC) Prevention Research Center (PRC) Vaccine Confidence Network (PRC VCN), 26 academic institutions were funded to increase COVID-19 vaccine confidence and uptake in their communities. Six sites (in communities located in Alabama, Illinois, Massachusetts, New York, South Carolina, and Texas) formed a workgroup to identify emergent themes, and share challenges and opportunities across projects. This essay describes their efforts to engage trusted messengers in vaccine activities, and discusses strategies to develop and sustain these types of partnerships in the future. All sites recruited trusted messengers with strong community relationships to engage in multiple activities to promote COVID-19 vaccine confidence and uptake. CDC and the PRCs provided data-driven, evidence-based training and support to enable trusted messengers to fully participate in the projects. We posit that trusted messengers are essential partners for informing public health campaigns, developing effective messages, and building trust with local communities. Flexible federal funding and local coordination are essential for creating and sustaining trusted messenger approaches that combine community needs and data-informed evidence to promote timely public health responses.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127474"},"PeriodicalIF":4.5,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144653635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Purification and characterization of recombinant neuraminidase as a potentially broadly protective influenza virus vaccine candidate","authors":"Fernando De Mathia ,&nbsp;Tobias Kargl ,&nbsp;Matthias Müller ,&nbsp;Irfan Erdem ,&nbsp;Brooks Hayes ,&nbsp;Eduard Puente-Massaguer ,&nbsp;Florian Krammer ,&nbsp;Nico Lingg","doi":"10.1016/j.vaccine.2025.127471","DOIUrl":"10.1016/j.vaccine.2025.127471","url":null,"abstract":"<div><div>Influenza viruses pose a significant public health threat, causing seasonal epidemics and occasional pandemics with substantial morbidity and mortality worldwide. The development of effective vaccines remains crucial for mitigating the impact of influenza virus infections. The influenza virus possesses two glycoproteins on its surface: hemagglutinin, which is immunodominant, and neuraminidase, which is immunosubdominant. Traditional influenza vaccines primarily target the viral surface glycoprotein hemagglutinin to induce protective immunity. However, the high mutation rate of this protein, particularly in response to selective pressure from immune responses, limits the durability and efficacy of current vaccines. Efficient production of influenza vaccines relies on scalable purification processes to ensure safe and efficacious antigens. Neuraminidase (NA), the second glycoprotein of influenza virus, has recently emerged as target for broadly protective protein subunit vaccine formulations, necessitating development of robust manufacturing and characterization methods for this antigen. Here we present a scalable approach for purifying recombinant NA, expressed in insect cells utilizing the baculovirus expression system. Lean purification processes, based on chromatography and tangential flow filtration, achieve high yield and purity while maintaining the target's structural integrity and biological activity. The purified product is characterized through a variety of techniques, which confirm its structural and functional properties, and the consistency of those throughout the experiments performed. Scalability from laboratory to manufacturing scale under good manufacturing practice (GMP) ensures reproducibility, thus advancing the development of recombinant NA-based vaccines for comprehensive influenza control.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127471"},"PeriodicalIF":4.5,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144597081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}