Pub Date : 2026-04-02Epub Date: 2026-02-14DOI: 10.1016/j.vaccine.2026.128333
Anass Abbad , Brian Lerman , Jordan Ehrenhaus , Diego Sebastian Ojeda , Charles Gleason , Gagandeep Singh , Zain Khalil , Ana Silvia Gonzalez-Reiche , Komal Srivastava , Ana Fernandez-Sesma , Andrea Gamarnik , Viviana Simon , Florian Krammer
{"title":"Corrigendum to “Sustained superior humoral immune responses of mRNA vaccines compared to Sputnik V viral vector COVID-19 vaccines in naïve and convalescent populations” [Vaccine 70 (2026) 128018]","authors":"Anass Abbad , Brian Lerman , Jordan Ehrenhaus , Diego Sebastian Ojeda , Charles Gleason , Gagandeep Singh , Zain Khalil , Ana Silvia Gonzalez-Reiche , Komal Srivastava , Ana Fernandez-Sesma , Andrea Gamarnik , Viviana Simon , Florian Krammer","doi":"10.1016/j.vaccine.2026.128333","DOIUrl":"10.1016/j.vaccine.2026.128333","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"77 ","pages":"Article 128333"},"PeriodicalIF":4.5,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146193068","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}
Pub Date : 2026-03-19Epub Date: 2026-02-10DOI: 10.1016/j.vaccine.2026.128308
Lucas Dufour , Jérôme Drouin , Rosemary Dray-Spira , Stéphane Le Vu
Background
Although HPV vaccination coverage has remained low in France, information on barriers to vaccination is incomplete. This nationwide study aimed to assess HPV vaccination uptake and associated factors alongside the evolving recommendations since its implementation.
Methods
Using data from the French National Health Data System (SNDS), all individuals aged 10–29 years were included. Annual HPV vaccination uptake between 2007 and 2023 was assessed by age group and sex. Associations between individuals' socio-demographic, healthcare use and access and medical characteristics with HPV vaccination were assessed using multivariable logistic regression models.
Findings
Among 27.9 million (M) individuals included, 5.9M received HPV vaccination: 3.4M (2.7M females/0.7M males) aged 10–14, 2.2M (1.9M/0.3M) aged 15–19, and 0.28M (240,000/40,000) aged 20–29. Annual vaccination uptake consistently increased since 2012, reaching up to 17.1% and 15.7% of 10–14-year-old females and males in 2023. Across all age and sex groups, socioeconomic disadvantage was associated with lower odds of vaccination (adjusted odds ratios ranging from 0.45 to 0.84 for complementary health insurance allowance beneficiaries, and from 0.55 to 0.73 for those living in the most deprived quintile of municipalities), and these disparities widened over time among females aged 10–19. While probability of HPV vaccination increased with the number of contacts with the primary healthcare system, Down syndrome, diabetes and mental health disorders were associated with decreased odds of HPV vaccination.
Interpretation
Until 2023, disadvantaged young people, those with limited access to healthcare or suffering from chronic illnesses, benefited less from HPV vaccination than those more privileged.
{"title":"Uptake of HPV vaccination and associated factors in France: a nationwide study from 2007 to 2023","authors":"Lucas Dufour , Jérôme Drouin , Rosemary Dray-Spira , Stéphane Le Vu","doi":"10.1016/j.vaccine.2026.128308","DOIUrl":"10.1016/j.vaccine.2026.128308","url":null,"abstract":"<div><h3>Background</h3><div>Although HPV vaccination coverage has remained low in France, information on barriers to vaccination is incomplete. This nationwide study aimed to assess HPV vaccination uptake and associated factors alongside the evolving recommendations since its implementation.</div></div><div><h3>Methods</h3><div>Using data from the French National Health Data System (SNDS), all individuals aged 10–29 years were included. Annual HPV vaccination uptake between 2007 and 2023 was assessed by age group and sex. Associations between individuals' socio-demographic, healthcare use and access and medical characteristics with HPV vaccination were assessed using multivariable logistic regression models.</div></div><div><h3>Findings</h3><div>Among 27.9 million (M) individuals included, 5.9M received HPV vaccination: 3.4M (2.7M females/0.7M males) aged 10–14, 2.2M (1.9M/0.3M) aged 15–19, and 0.28M (240,000/40,000) aged 20–29. Annual vaccination uptake consistently increased since 2012, reaching up to 17.1% and 15.7% of 10–14-year-old females and males in 2023. Across all age and sex groups, socioeconomic disadvantage was associated with lower odds of vaccination (adjusted odds ratios ranging from 0.45 to 0.84 for complementary health insurance allowance beneficiaries, and from 0.55 to 0.73 for those living in the most deprived quintile of municipalities), and these disparities widened over time among females aged 10–19. While probability of HPV vaccination increased with the number of contacts with the primary healthcare system, Down syndrome, diabetes and mental health disorders were associated with decreased odds of HPV vaccination.</div></div><div><h3>Interpretation</h3><div>Until 2023, disadvantaged young people, those with limited access to healthcare or suffering from chronic illnesses, benefited less from HPV vaccination than those more privileged.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128308"},"PeriodicalIF":4.5,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146168637","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}
Pub Date : 2026-03-19Epub Date: 2026-02-13DOI: 10.1016/j.vaccine.2026.128306
Kajal Radia , Shari Sapuan , Nicholas Grassly , Nick Andrews , Mary Ramsay , Vanessa Saliba , Laura Stephens , Javier Martin , Christine Jones , Elizabeth Miller , Paul T. Heath
A diphtheria-tetanus-acellular pertussis-inactivated polio combination vaccine (dTaP-IPV) was offered as part of the UK antenatal vaccination programme from 2012 to July 2024. Prior research established that infants of mothers who received a dTaP-IPV vaccine in pregnancy have significantly reduced poliovirus-specific neutralising antibodies after their primary immunisation series compared with infants of non-dTaP-IPV vaccinated mothers. We investigated whether sufficient poliovirus-specific neutralising antibody titres are achieved in these children following the pre-school dTaP-IPV booster vaccine. Poliovirus-specific neutralising antibody titres were measured, via a microneutralisation assay, prior to and following receipt of the pre-school booster vaccine in blood samples taken during an observational, cohort, multi-centre, open label phase IV extension study.
Prior to the pre-school boost, children of mothers who received dTaP-IPV vaccines in pregnancy had lower geometric mean titres (GMT) of antibodies than children of unvaccinated mothers (4.3 vs 54.7, p = 0.0001). However, following administration of the pre-school booster all children, regardless of maternal vaccination status achieved protective antibody titres (≥ 8), although children of vaccinated mothers still had lower GMTs (988 vs 2964, p = 0.009).
Administration of the preschool booster overcomes the polio virus immunity gap that develops following the primary vaccination series in children whose mothers received an antenatal dTaP-IPV vaccine versus unvaccinated mothers. Residual differences in post-booster titres warrant continued surveillance to assess their clinical relevance. Clinical trials registry:NCT03578120
作为2012年至2024年7月英国产前疫苗接种计划的一部分,提供了白喉-破伤风-无细胞百日咳-灭活脊髓灰质炎联合疫苗(dTaP-IPV)。先前的研究证实,与未接种dTaP-IPV疫苗的母亲的婴儿相比,在怀孕期间接种dTaP-IPV疫苗的母亲的婴儿在初次免疫系列后显著减少了脊髓灰质炎病毒特异性中和抗体。我们调查了这些儿童在学龄前接种dTaP-IPV加强疫苗后是否获得了足够的脊髓灰质炎病毒特异性中和抗体滴度。在一项观察性、队列、多中心、开放标签的第四期扩展研究中,在接受学前加强疫苗之前和之后,通过微量中和试验测量了脊髓灰质炎病毒特异性中和抗体滴度。在学龄前接种疫苗之前,母亲在怀孕期间接种dTaP-IPV疫苗的儿童的抗体几何平均滴度(GMT)低于未接种疫苗的母亲的儿童(4.3 vs 54.7, p = 0.0001)。然而,在接种学前增强疫苗后,所有儿童,无论母亲是否接种疫苗,都获得了保护性抗体滴度(≥8),尽管接种疫苗的母亲的孩子的GMTs仍然较低(988比2964,p = 0.009)。在母亲产前接种了dTaP-IPV疫苗的儿童与未接种疫苗的母亲之间,接种学前增强疫苗克服了在初次接种系列疫苗后产生的脊髓灰质炎病毒免疫差距。加强后滴度的剩余差异需要继续监测以评估其临床相关性。临床试验注册:NCT03578120
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Pub Date : 2026-03-19Epub Date: 2026-02-05DOI: 10.1016/j.vaccine.2026.128312
Emily A. Smith , Melissa Malhame , Stefano Malvolti , Gerald Voss , Saket Thaker , Angela K. Ulrich , Julia T. Ostrowsky , Derek F. Fleming , Nadia Cohen , Michael T. Osterholm , Eve M. Lackritz
Following the emergence of SARS-CoV-2, a global consensus arose on the need for a vaccine capable of protecting the human population from both known and unknown coronavirus threats. In April 2024, the Coalition for Epidemic Preparedness Innovations (CEPI) and the Center for Infectious Disease Research and Policy (CIDRAP) hosted a workshop to establish use cases for broadly protective coronavirus vaccines, using a pan-sarbecovirus vaccine candidate for prevention of SARS-CoV-X as an example. Workshop participants discussed implementation strategies and ideal product characteristics of pan-sarbecovirus vaccines that could be readily deployed within 100 days of SARS-CoV-X emergence. Here, we summarize the outputs from the workshop, which include the established use cases, as well as key considerations for research and development of pan-sarbecovirus vaccine candidates with characteristics to meet global needs. These use cases will be used to guide future investments and advance pandemic preparedness in line with CEPI’s mission to develop safe, effective, globally accessible vaccines in as little as 100 days.
{"title":"Use cases for pan-sarbecovirus vaccines: a workshop report","authors":"Emily A. Smith , Melissa Malhame , Stefano Malvolti , Gerald Voss , Saket Thaker , Angela K. Ulrich , Julia T. Ostrowsky , Derek F. Fleming , Nadia Cohen , Michael T. Osterholm , Eve M. Lackritz","doi":"10.1016/j.vaccine.2026.128312","DOIUrl":"10.1016/j.vaccine.2026.128312","url":null,"abstract":"<div><div>Following the emergence of SARS-CoV-2, a global consensus arose on the need for a vaccine capable of protecting the human population from both known and unknown coronavirus threats. In April 2024, the Coalition for Epidemic Preparedness Innovations (CEPI) and the Center for Infectious Disease Research and Policy (CIDRAP) hosted a workshop to establish use cases for broadly protective coronavirus vaccines, using a pan-sarbecovirus vaccine candidate for prevention of SARS-CoV-X as an example. Workshop participants discussed implementation strategies and ideal product characteristics of pan-sarbecovirus vaccines that could be readily deployed within 100 days of SARS-CoV-X emergence. Here, we summarize the outputs from the workshop, which include the established use cases, as well as key considerations for research and development of pan-sarbecovirus vaccine candidates with characteristics to meet global needs. These use cases will be used to guide future investments and advance pandemic preparedness in line with CEPI’s mission to develop safe, effective, globally accessible vaccines in as little as 100 days.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128312"},"PeriodicalIF":4.5,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146133905","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}
Pub Date : 2026-03-19Epub Date: 2026-02-10DOI: 10.1016/j.vaccine.2026.128334
Jason Semprini , Heather Brandt
As human papillomavirus (HPV)-associated cancers continue rising in rural America, identifying contributors to rural-urban gaps in HPV vaccination could inform public health priorities and targeted interventions. Analyzing nationally representative data from the 2022 National Health Interview Survey (NHIS), we evaluated rural-urban differences in HPV vaccination among individuals aged 9–29 years (all of whom were recommended to receive the HPV vaccine during adolescence since 2006). Generalized structural equation models adjusted for complex survey design, sociodemographic factors, and other vaccine utilization. Even after adjusting for other vaccine utilization, rural participants were 5.4%-points (CI = −9.7, −1.0) less likely to receive the HPV vaccine than urban participants. Rural-urban disparities in HPV vaccination varied by healthcare access barriers and geography, with the largest gap found in participants who were privately insured. Our work suggests that rural-urban disparities in HPV vaccination are driven by factors distinct from those associated with other vaccines and healthcare access.
{"title":"Exploring rural-urban disparities in HPV vaccine initiation: new insights from the 2022 national health interview survey","authors":"Jason Semprini , Heather Brandt","doi":"10.1016/j.vaccine.2026.128334","DOIUrl":"10.1016/j.vaccine.2026.128334","url":null,"abstract":"<div><div>As human papillomavirus (HPV)-associated cancers continue rising in rural America, identifying contributors to rural-urban gaps in HPV vaccination could inform public health priorities and targeted interventions. Analyzing nationally representative data from the 2022 National Health Interview Survey (NHIS), we evaluated rural-urban differences in HPV vaccination among individuals aged 9–29 years (all of whom were recommended to receive the HPV vaccine during adolescence since 2006). Generalized structural equation models adjusted for complex survey design, sociodemographic factors, and other vaccine utilization. Even after adjusting for other vaccine utilization, rural participants were 5.4%-points (CI = −9.7, −1.0) less likely to receive the HPV vaccine than urban participants. Rural-urban disparities in HPV vaccination varied by healthcare access barriers and geography, with the largest gap found in participants who were privately insured. Our work suggests that rural-urban disparities in HPV vaccination are driven by factors distinct from those associated with other vaccines and healthcare access.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128334"},"PeriodicalIF":4.5,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146168596","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}
Pub Date : 2026-03-19Epub Date: 2026-02-02DOI: 10.1016/j.vaccine.2026.128294
Sónia T. Almeida , A. Cristina Paulo , Alexandra S. Simões , Sara Handem , Bárbara Ferreira , Mariana F. Caleiro , Susana Morais , António-Brito Avô , Hermínia de Lencastre , Raquel Sá-Leão
Streptococcus pneumoniae remains a major cause of infectious disease globally, with young children serving as key reservoirs for transmission. This study evaluated pneumococcal carriage and serotype distribution among young children in Portugal, six months after the lifting of COVID-19 public health measures and seven years after the introduction of the 13-valent pneumococcal conjugate vaccine (PCV13) into the National Immunization Plan.
A cross-sectional study was conducted in late 2022 among children aged 18 months to 6 years attending day-care centers in an urban region. Saliva samples, vaccination records, and demographic/clinical data were collected. Pneumococcal carriage was determined by qPCR targeting lytA and piaB genes. Molecular serotyping of 65 serotypes/serogroups was performed. New primers/probes were designed and validated for serotypes/serogroups 5, 7A/F, 9A/V, 9N/L, 17F and 33A/F/37, expanding the range of serotypes that could be reliably identified.
Among 584 children, 34.9% were pneumococcal carriers. Carriage of PCV13 serotypes was low, except for serotypes 3 (7.8%) and 19F (5.4%). Among non-PCV13 serotypes, 23A (10.8%), 15B/C (10.3%), 23B (9.8%), and 11A/D (9.3%) were the most frequent. Theoretical coverage of PCV13, PCV15, and PCV20 was 17.6%, 23.0%, and 46.1%, respectively. Children 4–6 years were nearly 15 times more likely to carry PCV13 serotypes than those aged 18–24 months (p = 0.012).
Six months post-COVID-19 restrictions lifting, serotype distribution largely resembled the pre-pandemic period. Although saliva sampling had lower sensitivity than nasopharyngeal swabbing for estimating overall pneumococcal carriage prevalence, it was particularly useful to assess serotype distribution. Importantly, in a context where nasopharyngeal swabbing was met with reluctance, saliva sampling emerged as a practical, effective, and non-invasive alternative for pneumococcal serotype carriage surveillance.
{"title":"Pneumococcal carriage and serotype distribution in Portuguese children six months after the lifting of COVID-19 restrictions: rise in serotype 3 amid stable non-vaccine serotypes","authors":"Sónia T. Almeida , A. Cristina Paulo , Alexandra S. Simões , Sara Handem , Bárbara Ferreira , Mariana F. Caleiro , Susana Morais , António-Brito Avô , Hermínia de Lencastre , Raquel Sá-Leão","doi":"10.1016/j.vaccine.2026.128294","DOIUrl":"10.1016/j.vaccine.2026.128294","url":null,"abstract":"<div><div><em>Streptococcus pneumoniae</em> remains a major cause of infectious disease globally, with young children serving as key reservoirs for transmission. This study evaluated pneumococcal carriage and serotype distribution among young children in Portugal, six months after the lifting of COVID-19 public health measures and seven years after the introduction of the 13-valent pneumococcal conjugate vaccine (PCV13) into the National Immunization Plan.</div><div>A cross-sectional study was conducted in late 2022 among children aged 18 months to 6 years attending day-care centers in an urban region. Saliva samples, vaccination records, and demographic/clinical data were collected. Pneumococcal carriage was determined by qPCR targeting <em>lytA</em> and <em>piaB</em> genes. Molecular serotyping of 65 serotypes/serogroups was performed. New primers/probes were designed and validated for serotypes/serogroups 5, 7A/F, 9A/V, 9N/L, 17F and 33A/F/37, expanding the range of serotypes that could be reliably identified.</div><div>Among 584 children, 34.9% were pneumococcal carriers. Carriage of PCV13 serotypes was low, except for serotypes 3 (7.8%) and 19F (5.4%). Among non-PCV13 serotypes, 23A (10.8%), 15B/C (10.3%), 23B (9.8%), and 11A/D (9.3%) were the most frequent. Theoretical coverage of PCV13, PCV15, and PCV20 was 17.6%, 23.0%, and 46.1%, respectively. Children 4–6 years were nearly 15 times more likely to carry PCV13 serotypes than those aged 18–24 months (<em>p</em> = 0.012).</div><div>Six months post-COVID-19 restrictions lifting, serotype distribution largely resembled the pre-pandemic period. Although saliva sampling had lower sensitivity than nasopharyngeal swabbing for estimating overall pneumococcal carriage prevalence, it was particularly useful to assess serotype distribution. Importantly, in a context where nasopharyngeal swabbing was met with reluctance, saliva sampling emerged as a practical, effective, and non-invasive alternative for pneumococcal serotype carriage surveillance.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128294"},"PeriodicalIF":4.5,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146098570","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}
Pub Date : 2026-03-19Epub Date: 2026-02-04DOI: 10.1016/j.vaccine.2026.128260
Samiullah Khan , Andrea R. McWhorter , Daniel M. Andrews , Gregory J. Underwood , Robert J. Moore , Thi Thu Hao Van , Kapil K. Chousalkar
{"title":"Corrigendum to “An enhanced vaccination regime reduces the shedding of Salmonella Typhimurium from layer chickens” [Vaccine 72 (2026) 128115]","authors":"Samiullah Khan , Andrea R. McWhorter , Daniel M. Andrews , Gregory J. Underwood , Robert J. Moore , Thi Thu Hao Van , Kapil K. Chousalkar","doi":"10.1016/j.vaccine.2026.128260","DOIUrl":"10.1016/j.vaccine.2026.128260","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128260"},"PeriodicalIF":4.5,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146128131","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}
Pub Date : 2026-03-19Epub Date: 2026-02-05DOI: 10.1016/j.vaccine.2026.128286
Xinmo Ma , Lairun Jin , Jing Li , Pengfei Jin , Yue Liu , Feng Wen , Gang Zeng , Jingxin Li
Objectives
Despite the availability of enterovirus type 71 (EV71) vaccines, evidence on long-term protection remains limited. We aimed to establish a mathematical model for predicting the 20-year long-term protection of the EV71 vaccine.
Methods
We utilized data from a phase 3 trial in which infants and young children were randomized to receive either two doses of 400 U EV71 vaccine or placebo. Neutralizing antibody data (NTAb) were obtained from the immunogenicity subpopulation who were followed for 5 years. We compared candidate decay models using Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC), and selected the Segmented Power-law Model to fit antibody decay kinetics. Simulated datasets were generated via 10,000 iterations of Bootstrap sampling. We introduced dynamic exposure simulation with differential exposure rates before and after 2017, and applied a Scaled Logit Model to establish the association between NTAb titers and protective efficacy. Additionally, we performed stratified analysis by dividing the population into High, Medium, and Low responders based on initial antibody titers. Uncertainty was quantified using 95% confidence intervals (CI).
Results
The predicted geometric mean titers (GMT) were 168.30 (95% CI: [139.76, 202.67]) at Month 1, 111.28 (95% CI: [93.15, 132.95]) at Month 6, 93.80 (95% CI: [79.12, 111.20]) at Month 12, and 68.04 (95% CI: [60.38, 76.68]) at Month 240. The model predicts that the EV71 vaccine provides a protective efficacy of 80.19% (95% CI: [78.69%, 81.70%]) at Month 1, declining to 72.57% (95% CI: [71.35%, 73.80%]) at Year 20. Stratified analysis revealed that High Responders maintained 75.58% protection at Year 20, compared to 65.09% for Medium and 64.99% for Low Responders.
Conclusion
Under the current EV71 epidemic conditions in China, the two-dose regimen of the inactivated EV71 vaccine provides durable protection exceeding 72% for at least 20 years.
{"title":"Long-term protection of an inactivated enterovirus type 71 vaccine against hand, foot, and mouth diseases in children: a modelling study","authors":"Xinmo Ma , Lairun Jin , Jing Li , Pengfei Jin , Yue Liu , Feng Wen , Gang Zeng , Jingxin Li","doi":"10.1016/j.vaccine.2026.128286","DOIUrl":"10.1016/j.vaccine.2026.128286","url":null,"abstract":"<div><h3>Objectives</h3><div>Despite the availability of enterovirus type 71 (EV71) vaccines, evidence on long-term protection remains limited. We aimed to establish a mathematical model for predicting the 20-year long-term protection of the EV71 vaccine.</div></div><div><h3>Methods</h3><div>We utilized data from a phase 3 trial in which infants and young children were randomized to receive either two doses of 400 U EV71 vaccine or placebo. Neutralizing antibody data (NTAb) were obtained from the immunogenicity subpopulation who were followed for 5 years. We compared candidate decay models using Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC), and selected the Segmented Power-law Model to fit antibody decay kinetics. Simulated datasets were generated via 10,000 iterations of Bootstrap sampling. We introduced dynamic exposure simulation with differential exposure rates before and after 2017, and applied a Scaled Logit Model to establish the association between NTAb titers and protective efficacy. Additionally, we performed stratified analysis by dividing the population into High, Medium, and Low responders based on initial antibody titers. Uncertainty was quantified using 95% confidence intervals (CI).</div></div><div><h3>Results</h3><div>The predicted geometric mean titers (GMT) were 168.30 (95% CI: [139.76, 202.67]) at Month 1, 111.28 (95% CI: [93.15, 132.95]) at Month 6, 93.80 (95% CI: [79.12, 111.20]) at Month 12, and 68.04 (95% CI: [60.38, 76.68]) at Month 240. The model predicts that the EV71 vaccine provides a protective efficacy of 80.19% (95% CI: [78.69%, 81.70%]) at Month 1, declining to 72.57% (95% CI: [71.35%, 73.80%]) at Year 20. Stratified analysis revealed that High Responders maintained 75.58% protection at Year 20, compared to 65.09% for Medium and 64.99% for Low Responders.</div></div><div><h3>Conclusion</h3><div>Under the current EV71 epidemic conditions in China, the two-dose regimen of the inactivated EV71 vaccine provides durable protection exceeding 72% for at least 20 years.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128286"},"PeriodicalIF":4.5,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146133943","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}
Pub Date : 2026-03-19Epub Date: 2026-02-05DOI: 10.1016/j.vaccine.2026.128288
Deok-Hwan Kim , Jin-chel Kim , Seung-hun Lee , Jiwon Kim , Jei-hyun Jeong , Ji-yun Kim , Sohyun Seok , Joong-bok Lee , Seung-Young Park , In-Soo Choi , Sang-Won Lee , Chang-Seon Song
The widespread and endemic nature of recent highly pathogenic avian influenza virus H5N1 clade 2.3.4.4b outbreaks has driven increased vaccine demand. In this study, we used a Newcastle disease virus (NDV) vector expressing clade 2.3.4.4b H5 hemagglutinin (rK148/22-H5) to evaluate the efficacy of a single-dose vaccine administered via dual routes. We vaccinated 1-day-old broilers and randomly assigned them to HPAIV and viscerotropic velogenic NDV (vvNDV) challenges every 10 days. In the control group, maternal NDV antibodies waned by 20 days of age, whereas the antibody levels were sustained in the vaccinated group. Antibodies against HPAIV were first detected at 20 days post vaccination (dpv). Starting at 20 dpv, protection rates exceeded 70% and 90% against vvNDV and HPAIV challenges, respectively. Notably, at 30 dpv, no virus shedding was detected in the oropharyngeal and cloacal tissues following highly pathogenic avian influenza challenge. The rK148/22-H5 vaccine administered via the dual route is a promising candidate for single-dose vaccination to effectively protect young chicks against HPAIV and vvNDV.
{"title":"Efficacy of dual administration vaccine of recombinant Newcastle disease virus expressing clade 2.3.4.4b H5 hemagglutinin against H5N1 highly pathogenic avian influenza and viscerotropic Velogenic Newcastle disease virus in broilers","authors":"Deok-Hwan Kim , Jin-chel Kim , Seung-hun Lee , Jiwon Kim , Jei-hyun Jeong , Ji-yun Kim , Sohyun Seok , Joong-bok Lee , Seung-Young Park , In-Soo Choi , Sang-Won Lee , Chang-Seon Song","doi":"10.1016/j.vaccine.2026.128288","DOIUrl":"10.1016/j.vaccine.2026.128288","url":null,"abstract":"<div><div>The widespread and endemic nature of recent highly pathogenic avian influenza virus H5N1 clade 2.3.4.4b outbreaks has driven increased vaccine demand. In this study, we used a Newcastle disease virus (NDV) vector expressing clade 2.3.4.4b H5 hemagglutinin (rK148/22-H5) to evaluate the efficacy of a single-dose vaccine administered via dual routes. We vaccinated 1-day-old broilers and randomly assigned them to HPAIV and viscerotropic velogenic NDV (vvNDV) challenges every 10 days. In the control group, maternal NDV antibodies waned by 20 days of age, whereas the antibody levels were sustained in the vaccinated group. Antibodies against HPAIV were first detected at 20 days post vaccination (dpv). Starting at 20 dpv, protection rates exceeded 70% and 90% against vvNDV and HPAIV challenges, respectively. Notably, at 30 dpv, no virus shedding was detected in the oropharyngeal and cloacal tissues following highly pathogenic avian influenza challenge. The rK148/22-H5 vaccine administered via the dual route is a promising candidate for single-dose vaccination to effectively protect young chicks against HPAIV and vvNDV.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128288"},"PeriodicalIF":4.5,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146133865","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}
Pub Date : 2026-03-19Epub Date: 2026-02-10DOI: 10.1016/j.vaccine.2026.128304
Temitope Oyedele , Rachel Park , Kelly Morales , Manish Jain , Lawrence Sher , Apinya Vutikullird , Abby Isaacs , Brett Jepson , Kathryn Shoemaker , Ann Marie Stanley , Joseph Lee , Cindy Handelsman , Stacey Cromer Berman , Lee-Jah Chang
Background
The need for SARS-CoV-2 vaccines with improved potency, lower reactogenicity, broader coverage, and prolonged protection persists. We examined the safety and immunogenicity of two ferritin scaffold-based self-assembling SARS-CoV-2 mRNA virus-like particle (VLP) vaccines.
Methods
In this, randomized, Phase I, open-label, active-controlled study (www.clinicaltrials.govNCT06147063) participants received a single 5 μg or 10 μg intramuscular injection of AZD9838 (BA.4/5 variant) or AZD6563 (XBB.1.5 variant), or 30 μg BNT162b2, a licensed mRNA vaccine (XBB.1.5 variant).
The primary safety endpoint was the incidence of solicited adverse reactions (ARs) through Day 8, unsolicited adverse events (AEs) through Day 29, and serious AEs (SAEs), medically attended AEs (MAAEs), and AEs of special interest (AESIs) through Day 361. The primary immunogenicity endpoint was to characterize the neutralizing antibody (nAb) responses to the ancestral and Omicron (BA.4/5, XBB.1.5) variants at Day 29; characterization of nAb response to Omicron JN.1 was an exploratory analysis.
Results
In total, 166 participants aged 18–64 years and 76 participants ≥65 years of age were vaccinated. AZD9838 and AZD6563 were well-tolerated at both dosages. Overall, fewer solicited ARs were reported with AZD9838 and AZD6563 versus BNT162b2. Unsolicited AEs were similar between groups; no related SAEs, AESIs, or MAAEs were reported to Day 180.
Day 29 nAb GMTs were higher following 10 μg AZD6563 versus 5 μg and higher than AZD9838 across variants and age groups, remaining above baseline and similar to BNT162b2 at Day 180; 10 μg AZD6563 resulted in nAb GMTs similar to BNT162b2 in both age groups.
Conclusion
By combining mRNA vaccine technology with VLP-based antigen display, we developed two candidate SARS-CoV-2 vaccines, AZD9838 and AZD6563, that were well tolerated versus a licensed mRNA vaccine, BNT162b2. Furthermore, the variant-matched AZD6563 generated a similar immunogenicity to BNT162b2 but at one third of the dosage (10 μg versus 30 μg).
{"title":"A novel SARS-CoV-2 mRNA virus-like particle vaccine is highly potent and well tolerated in adults in a phase 1 randomized clinical trial","authors":"Temitope Oyedele , Rachel Park , Kelly Morales , Manish Jain , Lawrence Sher , Apinya Vutikullird , Abby Isaacs , Brett Jepson , Kathryn Shoemaker , Ann Marie Stanley , Joseph Lee , Cindy Handelsman , Stacey Cromer Berman , Lee-Jah Chang","doi":"10.1016/j.vaccine.2026.128304","DOIUrl":"10.1016/j.vaccine.2026.128304","url":null,"abstract":"<div><h3>Background</h3><div>The need for SARS-CoV-2 vaccines with improved potency, lower reactogenicity, broader coverage, and prolonged protection persists. We examined the safety and immunogenicity of two ferritin scaffold-based self-assembling SARS-CoV-2 mRNA virus-like particle (VLP) vaccines.</div></div><div><h3>Methods</h3><div>In this, randomized, Phase I, open-label, active-controlled study (<span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span> <span><span>NCT06147063</span><svg><path></path></svg></span>) participants received a single 5 μg or 10 μg intramuscular injection of AZD9838 (BA.4/5 variant) or AZD6563 (XBB.1.5 variant), or 30 μg BNT162b2, a licensed mRNA vaccine (XBB.1.5 variant).</div><div>The primary safety endpoint was the incidence of solicited adverse reactions (ARs) through Day 8, unsolicited adverse events (AEs) through Day 29, and serious AEs (SAEs), medically attended AEs (MAAEs), and AEs of special interest (AESIs) through Day 361. The primary immunogenicity endpoint was to characterize the neutralizing antibody (nAb) responses to the ancestral and Omicron (BA.4/5, XBB.1.5) variants at Day 29; characterization of nAb response to Omicron JN.1 was an exploratory analysis.</div></div><div><h3>Results</h3><div>In total, 166 participants aged 18–64 years and 76 participants ≥65 years of age were vaccinated. AZD9838 and AZD6563 were well-tolerated at both dosages. Overall, fewer solicited ARs were reported with AZD9838 and AZD6563 versus BNT162b2. Unsolicited AEs were similar between groups; no related SAEs, AESIs, or MAAEs were reported to Day 180.</div><div>Day 29 nAb GMTs were higher following 10 μg AZD6563 versus 5 μg and higher than AZD9838 across variants and age groups, remaining above baseline and similar to BNT162b2 at Day 180; 10 μg AZD6563 resulted in nAb GMTs similar to BNT162b2 in both age groups.</div></div><div><h3>Conclusion</h3><div>By combining mRNA vaccine technology with VLP-based antigen display, we developed two candidate SARS-CoV-2 vaccines, AZD9838 and AZD6563, that were well tolerated versus a licensed mRNA vaccine, BNT162b2. Furthermore, the variant-matched AZD6563 generated a similar immunogenicity to BNT162b2 but at one third of the dosage (10 μg versus 30 μg).</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"76 ","pages":"Article 128304"},"PeriodicalIF":4.5,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146145175","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}