VaccinePub Date : 2025-07-18DOI: 10.1016/j.vaccine.2025.127496
Eunseon Gwak , Seung-Ah Choe , Kyuwon Kim , Erdenetuya Bolormaa , Jonathan Fix , Muruga Vadivale , Matthew D. Rousculp , Young June Choe
{"title":"Real-world effectiveness of NVX-CoV2373 and BNT162b2 mRNA COVID-19 vaccination in South Korea","authors":"Eunseon Gwak , Seung-Ah Choe , Kyuwon Kim , Erdenetuya Bolormaa , Jonathan Fix , Muruga Vadivale , Matthew D. Rousculp , Young June Choe","doi":"10.1016/j.vaccine.2025.127496","DOIUrl":"10.1016/j.vaccine.2025.127496","url":null,"abstract":"<div><h3>Objectives</h3><div>In February 2022, NVX-CoV2373 became available in South Korea; real-world effectiveness of multiple doses compared with mRNA-based vaccines has not been thoroughly evaluated.</div></div><div><h3>Methods</h3><div>This retrospective study identified NVX-CoV2373 and BNT162b2 recipients aged ≥12 years from the K-COV-N database. Vaccine groups were propensity score–matched based on demographic characteristics, Seoul capital area residence, income level, comorbidity/disability, prior SARS-CoV-2 infection, and prior vaccination dose/timing. Outcomes were any and severe (intensive-care-unit admission or death within 8 weeks of infection) laboratory-confirmed SARS-CoV-2 infection assessed from 7 days after the third and fourth dose. Adjusted hazard ratios (aHRs) from matched groups measured vaccine effectiveness up to a 180-day risk window.</div></div><div><h3>Results</h3><div>From February to December 2022, 923,833 NVX-CoV2373 and 1,286,604 BNT162b2 doses were administered. The 180-day risk-window aHRs (95% CI) for NVX-CoV2373 compared with BNT162b2 for any SARS-CoV-2 infection were 0.78 (0.76–0.79) post third dose and 0.86 (0.86–0.87) post fourth dose. The 180-day aHRs (95% CI) for severe infection were 0.73 (0.53–1.00) after the third dose and 1.21 (1.03–1.42) after the fourth dose.</div></div><div><h3>Conclusions</h3><div>NVX-CoV2373 demonstrated favorable and similar effectiveness against any and severe SARS-CoV-2 infection, respectively, compared with BNT162b2, with evidence of enhanced NVX-CoV2373 durability.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127496"},"PeriodicalIF":4.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657242","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}
VaccinePub Date : 2025-07-18DOI: 10.1016/j.vaccine.2025.127507
Karen Cárdenas-Garzon , María Cecilia Agudelo , Olga Lucia Tovar-Aguirre , Caroline Reuter , Nelson Enrique Arias-Ortiz , Sandra Milena Franco , Kelly Paola Valverde , Samuel Agudelo , Isabel C. Garcés-Palacio , María Patricia Arbelaez , Nilton Edu Montoya , Difariney Gonzalez-Gómez , Karly S Louie , Simon Beddows , Gloria I. Sanchez
{"title":"Understanding the decline in HPV vaccination in Colombia: A population-based analysis of girls and parents in early rollout cohorts","authors":"Karen Cárdenas-Garzon , María Cecilia Agudelo , Olga Lucia Tovar-Aguirre , Caroline Reuter , Nelson Enrique Arias-Ortiz , Sandra Milena Franco , Kelly Paola Valverde , Samuel Agudelo , Isabel C. Garcés-Palacio , María Patricia Arbelaez , Nilton Edu Montoya , Difariney Gonzalez-Gómez , Karly S Louie , Simon Beddows , Gloria I. Sanchez","doi":"10.1016/j.vaccine.2025.127507","DOIUrl":"10.1016/j.vaccine.2025.127507","url":null,"abstract":"<div><div>Many countries in the world are facing challenges to reach the WHO proposed target of HPV vaccination of 90 % of girls by the age of 15. A population-based cross-sectional survey was conducted in Manizales, Colombia to identify sociodemographic factors and components of the health belief model related to HPV vaccination in the 2003, 2004, and 2005 birth cohorts of girls and their parents targeted by the national HPV vaccination program in 2012, 2013, and 2014. Complementary log-log generalized linear models were used to obtain adjusted Prevalence Ratios (aPR) and 95 % confidence intervals (CI). A lower prevalence of HPV vaccination was observed in girls of the 2004 (aPR 0.82; 95 % CI 0.71–0.92) and 2005 (aPR 0.61; 95 % CI 0.52–0.71) cohorts compared to the 2003 cohort. The higher scores of perceived benefits by girls (aPR 1.06; 95 % CI 1.05–1.08) or their parents (aPR 1.05; 95 % CI 1.03–1.06) were associated to a higher prevalence of HPV vaccination of the girls. Conversely, this prevalence decreased with perceived barriers by girls (aPR 0.94; 95 % CI 0.91–0.96) and parents (aPR 0.91; 95 % CI 0.88–0.94). Parent's education lower attainment, lower socioeconomic stratum, and subsidized (public) health insurance were related to decreased likelihood of HPV vaccination. The results suggest that campaigns for HPV vaccination require effective education strategies to improve public perception of the vaccine's safety and benefits. Decision-makers and implementers must address also other social determinants such as disparities in access to education by parents, the SES, and the type of health insurance to improve HPV vaccination coverage.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127507"},"PeriodicalIF":4.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657245","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}
VaccinePub Date : 2025-07-18DOI: 10.1016/j.vaccine.2025.127499
Anne-Sophie Barret , Céline François , Ala-Eddine Deghmane , Rémi Lefrançois , Lilas Mercuriali , Alexandra Thabuis , Cécile Marie , Elise Carraz-Billat , Laura Zanetti , Isabelle Parent du Châtelet , Muhamed-Kheir Taha
{"title":"Increase in invasive Haemophilus influenzae type b disease in young children despite high vaccination coverage, France, 2018–2024","authors":"Anne-Sophie Barret , Céline François , Ala-Eddine Deghmane , Rémi Lefrançois , Lilas Mercuriali , Alexandra Thabuis , Cécile Marie , Elise Carraz-Billat , Laura Zanetti , Isabelle Parent du Châtelet , Muhamed-Kheir Taha","doi":"10.1016/j.vaccine.2025.127499","DOIUrl":"10.1016/j.vaccine.2025.127499","url":null,"abstract":"<div><h3>Background</h3><div>The introduction of <em>Haemophilus influenzae</em> type b (Hib) conjugate vaccines in France led to low invasive Hib disease incidence for two decades. In 2013, the vaccination schedule changed from 3+1 to 2+1 ((2, 4, and 11 months). Hib vaccination has been mandatory for children born since 2018. Despite vaccination coverage exceeding 95%, invasive Hib disease has increased since 2018. This study reports trends and characteristics of cases in mainland France from 2018 to 2024.</div></div><div><h3>Methods</h3><div>Cases were children under five years old with invasive Hib disease confirmed by culture or PCR by the National Reference Center for <em>Haemophilus influenzae</em>. Vaccination status was reported by biologists/clinicians or by regional investigation teams. Cases were described by age and vaccination status (unvaccinated, partially vaccinated, correctly vaccinated). Vaccine failure was defined as invasive Hib disease despite completion of the three-dose series. Vaccine effectiveness (VE) for three doses was estimated using the screening method in children aged 2-4 years.</div></div><div><h3>Results</h3><div>The incidence of invasive Hib disease among children under 5 years old increased during the 2018-2024 period, peaking in 2021 with 46 cases (1.4/100,000 children). From 2018 to 2024, 181 cases of invasive Hib disease were reported. Among those aged 6-11 months (n=60), 76.7% were correctly vaccinated with two doses. In children ≥12 months (n=65), 67.7% were correctly vaccinated with three doses and there were 44 vaccine failures. The estimated VE for three doses was 91.2% [95% confidence interval: 76.3-96.8%].</div></div><div><h3>Discussion - Conclusion</h3><div>Invasive Hib disease increased among children under 5 years old in France during 2018-2024, and most cases were correctly vaccinated. VE estimate do not suggest waning immunity. The reasons that may explain the increase in invasive Hib cases remain uncertain. Our results call for further studies on the VE following the two primary doses and the impact of vaccination on carriage.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127499"},"PeriodicalIF":4.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657246","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}
VaccinePub Date : 2025-07-18DOI: 10.1016/j.vaccine.2025.127513
Flor M. Munoz , Beate Kampmann , Andy Stergachis , Manu Chaudhary , Clare L. Cutland , Asma Khalil , Angela Gentile , Christine E. Jones , Helen Marshall , Esperanca Sevene , Delese Mimi Darko , Geeta Swamy , Terri B. Hyde , Gerald Voss , Ajoke Sobanjo-Ter Muelen
{"title":"A template tool for the evaluation of vaccines for emerging pathogens to be used for pregnant and breast-feeding women","authors":"Flor M. Munoz , Beate Kampmann , Andy Stergachis , Manu Chaudhary , Clare L. Cutland , Asma Khalil , Angela Gentile , Christine E. Jones , Helen Marshall , Esperanca Sevene , Delese Mimi Darko , Geeta Swamy , Terri B. Hyde , Gerald Voss , Ajoke Sobanjo-Ter Muelen","doi":"10.1016/j.vaccine.2025.127513","DOIUrl":"10.1016/j.vaccine.2025.127513","url":null,"abstract":"<div><div>Vaccination during pregnancy provides effective protection against pathogens that increase the risk of maternal and infant morbidity and mortality for mothers and their infants. The SARS-CoV-2 pandemic demonstrated the need for the inclusion of pregnant and breast-feeding women in research and development of vaccines for emerging pathogens, such as Ebola, Zika, Lassa fever, Chikungunya, and influenza virus of pandemic potential. The COVID-19 Vaccines Global Access (COVAX) Maternal Immunization Working Group (MIWG), in collaboration with the Coalition for Epidemic Preparedness Innovation and the Safety Platform for Emergency Vaccines (CEPI-SPEAC) developed a standardized template with key considerations to guide the assessment of vaccines against emerging pathogens in pregnant and breast-feeding women. The aim of this tool is to enable key stakeholders to perform an early structured assessment of the overall potential benefit and risk for maternal immunization against an emerging pathogen. It can also be used to support risk management and pharmacovigilance planning, communication strategies, policy development, and acceptance of vaccination during pregnancy in future pandemics.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127513"},"PeriodicalIF":4.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144655027","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}
VaccinePub Date : 2025-07-17DOI: 10.1016/j.vaccine.2025.127495
Taylor D. Bostic , Sarah A. Hook , Grace E. Marx
{"title":"Lyme disease vaccine acceptability among healthcare providers ― United States, 2018 and 2022","authors":"Taylor D. Bostic , Sarah A. Hook , Grace E. Marx","doi":"10.1016/j.vaccine.2025.127495","DOIUrl":"10.1016/j.vaccine.2025.127495","url":null,"abstract":"<div><h3>Background</h3><div>A Lyme disease (LD) vaccine is expected to become available soon. We aimed to understand recent trends in healthcare provider (HCP) willingness to recommend LD vaccination.</div></div><div><h3>Methods</h3><div>Cross-sectional surveys among HCPs were conducted in 2018 and 2022. We compared willingness to recommend LD vaccination by survey year and provider characteristics.</div></div><div><h3>Results</h3><div>Among 3005 HCPs, 70.5 % reported willingness to recommend LD vaccination. This proportion was lower in 2022 than in 2018 (68 % vs 73 %; <em>p</em> < 0.01) and did not differ significantly by provider medical specialty. More HCPs in states with high LD incidence were willing to recommend the vaccine compared to HCPs in neighboring or low-incidence states (<em>p</em> < 0.01). Vaccine safety was the most frequently reported consideration for recommending LD vaccination (73 %).</div></div><div><h3>Conclusions</h3><div>HCP willingness to recommend LD vaccination decreased from 2018 to 2022. Vaccination education tailored to HCPs that address vaccine safety will be critical for a successful LD vaccination program.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127495"},"PeriodicalIF":4.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144655026","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}
VaccinePub Date : 2025-07-17DOI: 10.1016/j.vaccine.2025.127519
Tingsu Tao , Yajuan Ni , Naiyang Shi , Xuying Yang , Hui Jin
{"title":"Human papillomavirus vaccination coverage and willingness among women in mainland China: A meta-analysis based on the COM-B model","authors":"Tingsu Tao , Yajuan Ni , Naiyang Shi , Xuying Yang , Hui Jin","doi":"10.1016/j.vaccine.2025.127519","DOIUrl":"10.1016/j.vaccine.2025.127519","url":null,"abstract":"<div><h3>Objectives</h3><div>To estimate human papillomavirus (HPV) vaccination coverage and vaccination willingness among women in mainland China and identify the influencing factors using the Capability, Opportunity, and Motivation model of Behavior (COM<img>B).</div></div><div><h3>Methods</h3><div>PubMed, Web of Science, Cochrane Library, Embase, and Chinese databases including CNKI, Wanfang Data, VIP, and CBM were searched. Pooled HPV vaccination coverage and willingness were calculated using a random-effects model with 95 % confidence intervals (CIs). Subgroup analyses and meta-regression were performed to explore heterogeneity. The COM-B model and the Theoretical Domains Framework (TDF) were employed to identify factors associated with vaccination coverage and willingness. Dichotomous outcomes were presented as odds ratios (OR) with the corresponding 95 % CIs.</div></div><div><h3>Results</h3><div>A total of 155 articles, including 10,965,863 mainland Chinese women, were included. The pooled vaccination coverage in 80 included studies was 9.5 % (95 % CI: 7.6 %–11.6 %). Subgroup analysis indicated a higher vaccination rate among women undergoing HPV or cervical cancer screening (16.9 %, 95 % CI: 10.5 %–24.4 %) and among healthcare workers (13.4 %, 95 % CI: 5.6 %–23.8 %). Vaccination willingness, based on 126 studies, was 70.6 % (95 % CI: 66.8 %–74.3 %). Furthermore, the three dimensions of the COM-B model were found to significantly influence both vaccination coverage and willingness (<em>P</em> < 0.05), with capability showed the strongest correlation with HPV vaccination coverage (OR = 2.96, 95 % CI: 2.20–3.99).</div></div><div><h3>Conclusions</h3><div>There was a significant gap between vaccination willingness and actual coverage among mainland Chinese women. HPV vaccination status of family members or friends and knowledge of HPV and its vaccines were associated with higher vaccination rates.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127519"},"PeriodicalIF":4.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657185","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}
VaccinePub Date : 2025-07-17DOI: 10.1016/j.vaccine.2025.127486
Yukihiro Shibuya
{"title":"Culture filtrate proteins from Bacillus Calmette–Guérin","authors":"Yukihiro Shibuya","doi":"10.1016/j.vaccine.2025.127486","DOIUrl":"10.1016/j.vaccine.2025.127486","url":null,"abstract":"<div><div><em>Mycobacterium bovis</em> Bacillus Calmette–Guérin (BCG) has long been used as a vaccine against tuberculosis and bladder cancer. BCG is also an effective adjuvant; it has long been known that its cell wall acts as an adjuvant. Recent research has revealed that various lipids and glycolipids are involved in the induction of innate immunity as ligands for C-type lectin receptors. However, the effects of the components of BCG used as adjuvants are not comparable to those of live BCG. On the other hand, since live bacteria are essential for the protective effect of BCG, a hypothesis has been proposed that proteins actively secreted by living bacteria are responsible for important immune responses, and various secreted proteins have been characterized. However, this hypothesis has not yet been verified. In this review, we discuss the purification, identification, and characterization of BCG-secreted proteins, namely culture filtrate proteins (CFP), and mention new possibilities for CFP.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127486"},"PeriodicalIF":4.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657243","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}
VaccinePub Date : 2025-07-17DOI: 10.1016/j.vaccine.2025.127508
A. Abhiram , Rahul Krishnan , A.K. Ahalya , Shelina Shaji , Devika Pillai , Rameez Roshan , M.P. Safeena
{"title":"Development of oral vaccine using calcium phosphate nanoparticles conjugated with outer membrane protein of Aeromonas hydrophila in Oreochromis niloticus (Tilapia)","authors":"A. Abhiram , Rahul Krishnan , A.K. Ahalya , Shelina Shaji , Devika Pillai , Rameez Roshan , M.P. Safeena","doi":"10.1016/j.vaccine.2025.127508","DOIUrl":"10.1016/j.vaccine.2025.127508","url":null,"abstract":"<div><div>The development of an effective vaccine for <em>Oreochromis niloticus</em> (Tilapia) against <em>Aeromonas hydrophila</em>, a major pathogen in aquaculture, is crucial for enhancing disease resistance and sustainability in fish farming. This study investigates the use of calcium phosphate (CaP) nanoparticles conjugated with the outer membrane protein (OMP) of <em>A. hydrophila</em> as a novel vaccine delivery system, referred to as CaP-OMP. Specific IgM response and Opsonophagocytic killing activity (OPKA) demonstrated improved <em>Aeromonas</em> clearance in vaccinated fish. Furthermore, immune gene expression analysis was performed using quantitative PCR (qPCR) to monitor the expression levels of key immune genes. The results showed a significant upregulation of these immune markers in the CaP-OMP vaccinated groups compared to that of OMP vaccinated groups, suggesting enhanced activation of both the innate and adaptive immune responses. The protective efficacy of the vaccine was demonstrated by a relative percentage survival (RPS) of 85.7 %, indicating significantly lower mortality in the CaP-OMP vaccinated group compared to controls following a challenge study with virulent <em>A. hydrophila</em>. Overall, This oral vaccine approach offers a non-invasive alternative for fish immunization and underscores the potential of calcium phosphate nanoparticles conjugated with outer membrane proteins as a promising vaccine platform for aquaculture. The enhanced immune response, combined with targeted antigen delivery, positions this strategy as a viable tool for controlling <em>A. hydrophila</em> infections in Tilapia, contributing to improved disease management in aquaculture.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127508"},"PeriodicalIF":4.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657244","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}
VaccinePub Date : 2025-07-17DOI: 10.1016/j.vaccine.2025.127516
Kazunari Kamachi, Tsuyoshi Kenri
{"title":"A novel 96-well in vitro assay for assessing pertussis toxin activity in the final products of acellular pertussis combination vaccines","authors":"Kazunari Kamachi, Tsuyoshi Kenri","doi":"10.1016/j.vaccine.2025.127516","DOIUrl":"10.1016/j.vaccine.2025.127516","url":null,"abstract":"<div><div><em>Bordetella pertussis</em> produces pertussis toxin (PT) as a major virulence factor; detoxified PT is an essential antigen for acellular pertussis vaccines. The toxicity of PT (residual toxicity and reversion to toxicity) in pertussis vaccines has long been assessed using the mouse histamine sensitization test (HIST). In this study, as an alternative to animal safety testing-based HIST, a 96-well <em>in vitro</em> assay (fetuin-ADP-ribosylation assay), which assesses both the ADP-ribosyltransferase of the S1 subunit and the carbohydrate-binding activities of the B-oligomer in PT, was developed and evaluated for its applicability to the final products of acellular pertussis combination vaccines, DPT, DPT-IPV, and DPT-IPV-Hib. The fetuin-ADPR assay is based on a two-step process: (i) recovery of PT antigen with retained carbohydrate-binding activity from vaccine samples using fetuin-coated magnetic beads, and (ii) measurement of ADP-ribosyltransferase activity of the recovered PT antigen using a 96-well microplate immobilized with the target molecule, Gα<sub>i3</sub>C20 peptide. In the assay system, the standard curve of the PT reference NIBSC 90/518 exhibited a linear response up to 320 ng/mL (R<sup>2</sup> ≥ 0.98). The fetuin-ADPR assay showed that the activatable PT content in most final vaccine products stored at 4 °C was <20 ng/mL (below the detection limit), whereas that in vaccines stored at 37 °C for 28 days ranged from <20 to 159.7 ng/mL. The assay successfully detected the reversion to toxicity of detoxified PT. Validation of the fetuin-ADPR assay showed a day-to-day reproducibility of 27.5 % coefficient of variation and 44–50 % accuracy as assessed by spike recovery. The fetuin-ADPR assay has the advantage of being performed in a 96-well plate with standard laboratory equipment, and is a promising alternative to <em>in vivo</em> HIST for assessing PT toxicity in the final products of acellular pertussis combination vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127516"},"PeriodicalIF":4.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657314","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}
VaccinePub Date : 2025-07-17DOI: 10.1016/j.vaccine.2025.127506
Harry Pickering , Eduardo Valli , Michael A. Carlock , Monica Cappelletti , David W. Gjertson , Ted M. Ross , Elaine F. Reed
{"title":"Influenza strain-specific T cell responses longitudinally post-vaccination with FluZone","authors":"Harry Pickering , Eduardo Valli , Michael A. Carlock , Monica Cappelletti , David W. Gjertson , Ted M. Ross , Elaine F. Reed","doi":"10.1016/j.vaccine.2025.127506","DOIUrl":"10.1016/j.vaccine.2025.127506","url":null,"abstract":"<div><div>Despite seasonal vaccination strategies, influenza viruses still cause significant morbidity and mortality. While vaccine efficacy is generally high, effectiveness varies from year-to-year and can be impacted by numerous host factors, including age, sex, obesity, and immune history. Therefore, understanding host immune factors that promote robust vaccine responses and protection from influenza infection and disease, is important for improving vaccine design and evaluation. This study focuses on influenza-specific T cells, an understudied component of influenza vaccination responses and long-term protection from infection.</div><div>This study measured influenza strain-specific T cell responses in 40 participants longitudinally following immunization with the inactivated, quadrivalent FluZone vaccine. Influenza-specific T cells were restimulated using live virus representing the four strains included in the FluZone construct. Strain-specific T cell responses were correlated with plasma chemokine and cytokine levels, and humoral immunity, quantified by hemagglutination inhibition assay.</div><div>Activated and degranulating T cells were frequently detected against all strains longitudinally post-vaccination and positively correlated with serological responses. Cytokine-producing T cells were less frequently detected, and they peaked early post-vaccination, concurrent with elevated plasma IFNγ and CCL4. Changes in strain-specific T cells post-vaccination and correlation with serological responses was stronger for influenza A subtypes than B subtypes.</div><div>Dynamics of cytokine-producing T cells early post-influenza vaccination may reflect ongoing immune responses, but activated and degranulating T cells better represent longitudinal changes in serological responses. Differences between T cells specific to influenza A and B subtypes warrant further investigation to understand why they diverge and the relevance to vaccine design and evaluation.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127506"},"PeriodicalIF":4.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657315","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}