VaccinePub Date : 2025-10-17DOI: 10.1016/j.vaccine.2025.127826
Bei Liu , Ninghua Huang , Yaqiong Liu , Xiyu Zhang , Bing Wu , Bing Cao , Tao Sun , Yudong Miao , Fuqiang Cui
{"title":"Parental perceptions and willingness to pay for childhood vaccination experiences in China: a multi-city comprehensive evaluation study","authors":"Bei Liu , Ninghua Huang , Yaqiong Liu , Xiyu Zhang , Bing Wu , Bing Cao , Tao Sun , Yudong Miao , Fuqiang Cui","doi":"10.1016/j.vaccine.2025.127826","DOIUrl":"10.1016/j.vaccine.2025.127826","url":null,"abstract":"<div><h3>Background</h3><div>With China's evolving family policies and rising parental expectations, there is increasing demand for improved childhood vaccination experiences. This study aimed to assess Chinese parents' comprehensive perceptions and willingness to pay (WTP) for childhood vaccination experience improvements, with particular focus on combination vaccine preferences.</div></div><div><h3>Methods</h3><div>A multi-city cross-sectional survey was conducted from January to December 2021 across five cities representing China's eastern, central, and western regions. Face-to-face interviews were conducted with 1845 parents of children aged 1–18 months in 60 community health service centers. The study employed questionnaire surveys, discrete choice experiments (DCE) with four attributes (injection frequency, diseases prevented per dose, vaccination coverage rates, and cost), and contingent valuation methods to assess WTP for specific vaccination benefits including pain reduction, adverse reaction prevention, and convenience improvements.</div></div><div><h3>Results</h3><div>Participants had a mean age of 30.95 ± 4.34 years, with 79 % being mothers and 66.4 % having bachelor's degrees. Over two-thirds (67.84 %) expressed strong concerns about adverse reactions, 74.40 % reported significant child crying during vaccination, and 65.02 % considered travel time to vaccination sites excessive. DCE analysis revealed strong stated preferences for fewer injections, vaccines preventing more diseases per dose, higher on-time vaccination coverage, and lower costs (all <em>p</em> < 0.001). Parents demonstrated highest WTP for preventing serious adverse reactions (54.53 % willing to pay 200 CNY[approximately 28 USD] per avoided reaction), substantially exceeding WTP for convenience factors. Education level, income, and age were key determinants of WTP, with postgraduate-educated parents showing 32.86–58.13 CNY(approximately 4.6–8.1 USD) higher WTP across different benefits compared to those with high school education or below.</div></div><div><h3>Conclusions</h3><div>Chinese parents prioritize vaccine safety over convenience factors, with significant concerns about adverse reactions and strong preferences for combination vaccines offering reduced injection frequency. The findings support policy initiatives emphasizing combination vaccine development, government procurement programs, and enhanced safety communication to improve childhood vaccination experiences and coverage rates.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"67 ","pages":"Article 127826"},"PeriodicalIF":4.5,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145319067","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":"Contributing factors to reversed willingness to vaccinate after the COVID-19 pandemic: Insights from a national panel survey","authors":"Koh Oikawa , Michio Murakami , Sae Ochi , Mei Yamagata , Asako Miura","doi":"10.1016/j.vaccine.2025.127869","DOIUrl":"10.1016/j.vaccine.2025.127869","url":null,"abstract":"<div><h3>Introduction</h3><div>Vaccination shows effectiveness at personal and community levels. To manage vaccine demand and supply, effectively promote vaccination, and plan future vaccination strategies, it is crucial to understand the change in the population's willingness over time. Extreme changes in vaccination willingness can affect vaccine oversupply and shortage. Few longitudinal studies have focused on vaccination willingness after the COVID-19 pandemic. Therefore, we sought to explore temporal changes in COVID-19 vaccination willingness and identify associated variables during and after the pandemic.</div></div><div><h3>Methods</h3><div>A 4-year panel survey was conducted in Japan between January 2020 and March 2024. To evaluate changes in COVID-19 vaccine willingness and identify associated factors, we assessed vaccine hesitancy in September 2022 (i.e., previously vaccinated individuals who did not wish to receive future vaccinations) and unreversed willingness to vaccinate in March 2024 (i.e., previously vaccinated individuals who wished to receive future vaccinations and wished to receive vaccination in September 2022). Modified Poisson regression was performed to examine the predictors of vaccine hesitancy and unreversed willingness to vaccinate.</div></div><div><h3>Results</h3><div>Vaccination willingness declined from 51.0 % in September 2022 to 19.9 % in March 2024. Man, interest in COVID-19, risk perception, age, and agreement with government policies were negatively associated with vaccine hesitancy. Family experience of infection emerged as a borderline-significant negative factor in unreversed willingness to vaccinate.</div></div><div><h3>Discussion</h3><div>Populations with younger populations, women, and people with low dread risk of perception for COVID-19 may have a low initial vaccination demand, which may decrease even after the pandemic ends. Vaccine demand may change within the same population. Therefore, it is crucial to reassess and adjust distribution strategies based on population characteristics.</div></div><div><h3>Conclusion</h3><div>It is essential to consider these associated factors and adjust the balance between vaccine supply and demand over time to maintain adequate coverage and prevent waste of resources.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"67 ","pages":"Article 127869"},"PeriodicalIF":4.5,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145331506","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 : 2025-10-16DOI: 10.1016/j.vaccine.2025.127837
Yoseph Caraco , Noa Madar-Balakirski , Eytan Ben-Ami , David Zeltser , Shlomo Maayan , Noa Eliakim-Raz , Avivit Peer , Tal Brosh-Nissimov , Victor Vishlitzky , Adi Beth-Din , Erez Bar-Haim , Tomer Israely , Nir Paran , Morly Fisher , Matti Hoggeg , Jacob Atsmon , Daniel Cohen , Dan Goldstaub , Yotam Levin , Yehuda Danon , Hadar Marcus
{"title":"Using the vesicular stomatitis virus vector (rVSV vector) platform for SARS-CoV-2 vaccine development: Phase 1/2 safety and immunogenicity of IIBR-100 in healthy adults","authors":"Yoseph Caraco , Noa Madar-Balakirski , Eytan Ben-Ami , David Zeltser , Shlomo Maayan , Noa Eliakim-Raz , Avivit Peer , Tal Brosh-Nissimov , Victor Vishlitzky , Adi Beth-Din , Erez Bar-Haim , Tomer Israely , Nir Paran , Morly Fisher , Matti Hoggeg , Jacob Atsmon , Daniel Cohen , Dan Goldstaub , Yotam Levin , Yehuda Danon , Hadar Marcus","doi":"10.1016/j.vaccine.2025.127837","DOIUrl":"10.1016/j.vaccine.2025.127837","url":null,"abstract":"<div><h3>Background</h3><div>We investigated the safety and immunogenicity of the IIBR-100 (rVSV-SARS-CoV-2-S) vaccine, a recombinant VSV-ΔG-spike vaccine against SARS-CoV-2 virus.</div></div><div><h3>Methods</h3><div>In a phase 1/2, randomized, observer-blind, placebo-controlled study (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>: NCT 04608305), healthy younger (18–55 years) and older (56–85 years) adults were recruited from eight clinical sites in Israel. In the phase 1 study, low (1 × 10<sup>5</sup> PFU), mid (1 × 10<sup>6</sup> PFU), and high doses (1 × 10<sup>7</sup> PFU) of IIBR-100 were tested in a single-dose treatment regimen, with an additional booster dose for the low-dose group only. Based on the phase 1 study results, only mid- and high-dose prime-boost regimens alongside an additional top dose (1 × 10<sup>8</sup> PFU) were tested in the phase 2 study. Participants, randomly assigned to either IIBR-100 or placebo, were followed for 12 months from the last vaccination for safety and immunogenicity outcomes.</div></div><div><h3>Findings</h3><div>No safety concerns were observed in the phase 1 study (<em>N</em> = 82); therefore, the study moved on to phase 2. In phase 2 (<em>N</em> = 762), for both age groups, the most common AEs included injection-site pain (20–64 %), fatigue (21–33 %), and headache (15–22 %). In the top-dose group, neutralizing and binding antibody titers peaked on Days 35 and 42, respectively; seroconversion rates reached maximal levels by Day 56 for neutralizing antibody and binding antibody (spike and RBD).</div></div><div><h3>Interpretation</h3><div>The IIBR-100 vaccine against SARS-CoV-2 in prime-boost regimens at 1 × 10<sup>7</sup> PFU/mL and 1 × 10<sup>8</sup> PFU/mL doses is safe, well tolerated, and immunogenic in healthy adults.</div></div><div><h3>Clinical trial registry</h3><div>This trial is registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT 04608305) and in the trial registry of the Israeli Ministry of Health website.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"67 ","pages":"Article 127837"},"PeriodicalIF":4.5,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145314405","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 : 2025-10-15DOI: 10.1016/j.vaccine.2025.127856
Lucy R. Williams , Merryn Voysey , Andrew J. Pollard , Nicholas C. Grassly
{"title":"A statistical method for evaluating vaccine-induced immune correlates of protection against infection and disease progression: application to the ChAdOx1-S nCoV-19 phase 3 trial","authors":"Lucy R. Williams , Merryn Voysey , Andrew J. Pollard , Nicholas C. Grassly","doi":"10.1016/j.vaccine.2025.127856","DOIUrl":"10.1016/j.vaccine.2025.127856","url":null,"abstract":"<div><h3>Background</h3><div>Correlates of protection (CoPs), defined as immune markers statistically correlated with vaccine efficacy (VE), can be used to accelerate vaccine development. Different components of the immune response may be important for protection against infection and against progression from asymptomatic infection to symptomatic or severe disease. However, CoPs are typically evaluated for these outcomes separately, which can lead to some CoPs not being identified. We propose a novel statistical framework for the integrated evaluation of CoPs for infections with multiple potential outcomes.</div></div><div><h3>Methods</h3><div>We developed a model of the natural history of an infection that can identify CoPs at each stage of infection and disease progression and implemented this model in a Bayesian estimation framework. We validated the model on simulated data then applied it to individual-level clinical and serum neutralising and binding antibody data from COV002 (<span><span>NCT04400838</span><svg><path></path></svg></span>), a phase II/III trial of the ChAdOx1 nCoV-19 (AZD1222) vaccine. We explored logistic and non-parametric (cubic spline) relationships between VE and the candidate CoPs.</div></div><div><h3>Results</h3><div>Both parametric and non-parametric forms of the model accurately estimated the relationships between the immune CoP and VE against infection (<span><math><msub><mi>VE</mi><mi>in</mi></msub></math></span>) and against progression to symptoms given infection (<span><math><msub><mi>VE</mi><mi>pr</mi></msub></math></span>) in 1000 simulated trial datasets. In the COV002 correlates subset (2227 participants, 5315 samples), SARS-CoV-2 spike-specific IgG was positively associated with both <span><math><msub><mi>VE</mi><mi>in</mi></msub></math></span> and <span><math><msub><mi>VE</mi><mi>pr</mi></msub></math></span> (average proportion of VE mediated by spike-specific IgG, 27 % (95 % CI 2–88 %) for <span><math><msub><mi>VE</mi><mi>in</mi></msub></math></span> and 41 % (95 % CI 0–96 %) for <span><math><msub><mi>VE</mi><mi>pr</mi></msub></math></span>). Pseudoneutralisation antibody titres and receptor binding domain (RBD) specific serum IgG showed similar correlations.</div></div><div><h3>Conclusion</h3><div>Integrated analysis of multiple disease outcomes and candidate CoPs enables the identification of CoPs that operate at different stages of disease progression, which are missed when evaluating outcomes separately.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"67 ","pages":"Article 127856"},"PeriodicalIF":4.5,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145310519","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 : 2025-10-15DOI: 10.1016/j.vaccine.2025.127834
Michael J. Cima , Christina Joshua , Namvar Zohoori , Austin Porter III , Derek Slagle , Jennifer Dillaha
{"title":"Hesitancy towards routine childhood vaccinations before and after the COVID-19 pandemic in Arkansas","authors":"Michael J. Cima , Christina Joshua , Namvar Zohoori , Austin Porter III , Derek Slagle , Jennifer Dillaha","doi":"10.1016/j.vaccine.2025.127834","DOIUrl":"10.1016/j.vaccine.2025.127834","url":null,"abstract":"<div><h3>Objective</h3><div>Prior to the COVID-19 pandemic, vaccine-preventable diseases increased nationally, associated with low childhood vaccination coverage. Studies on parental vaccine hesitancy in southern U.S. states is limited, and childhood vaccine uptake has decreased since early 2020. Our study purpose was to examine parental vaccine hesitancy before and after the COVID-19 pandemic among Arkansas residents.</div></div><div><h3>Methods</h3><div>A repeated cross-sectional design using telephone surveys was conducted among Arkansas parental guardians of children aged ≤6 years in 2019 (<em>n</em> = 407) and 2023 (<em>n</em> = 402). Parental hesitancy towards routine childhood vaccines and vaccine confidence was assessed. Weighted multiple logistic regression models examined associations between sociodemographic factors and parental hesitancy.</div></div><div><h3>Results</h3><div>Parental hesitancy increased 15-percentage points from 2019 to 2023 (35.7 % [38.6% – 43.0 %] to 50.3 % [40.7 % - 60.0 %]), while those expressing no hesitancy declined (64.3 % [56.7 % - 71.0 %] to 49.7 % [40.2 % - 59.0 %]). The association between parental age and vaccine hesitancy differed by region, with older parents in the Southwest region (and similarly in the Northeast and Northwest) showing greater hesitancy compared to those in the Central region (OR 1.21 [1.07–1.35]). Compared to parents of public-school children, those with privately schooled (OR 2.60 [1.22–5.51]) or homeschooled children (OR 2.65 [1.24–5.67]) had higher odds of hesitancy.</div></div><div><h3>Conclusions</h3><div>Despite low annual response rates, findings suggest an increase in parental vaccine hesitancy following the COVID-19 pandemic in Arkansas. Vaccine hesitancy remains a concern in our largely rural population. Repeat analyses with similar survey tools is needed to understand if these trends are maintained in the Arkansas population or similar southern rural populations.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"66 ","pages":"Article 127834"},"PeriodicalIF":4.5,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145314486","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 : 2025-10-14DOI: 10.1016/j.vaccine.2025.127851
Emma Falling Iversen , Anna H.F. Rahimic , Giacomo S. Frattari , Miriam Rosás-Umbert , Mariane H. Schleimann , Rikke Olesen , Jesper D. Gunst , Ole S. Søgaard , Michelle Krogsgaard , Martin Tolstrup
{"title":"TCR bias drives development of dominant vaccine-induced CD8+ T cell responses which can be redirected toward cellular targets","authors":"Emma Falling Iversen , Anna H.F. Rahimic , Giacomo S. Frattari , Miriam Rosás-Umbert , Mariane H. Schleimann , Rikke Olesen , Jesper D. Gunst , Ole S. Søgaard , Michelle Krogsgaard , Martin Tolstrup","doi":"10.1016/j.vaccine.2025.127851","DOIUrl":"10.1016/j.vaccine.2025.127851","url":null,"abstract":"<div><div>The yellow fever (YF) vaccine is known to elicit strong CD8+ T cell immune responses, predominantly targeting an HLA-A2-restricted immunodominant epitope within the NS4B protein. We aimed to characterize these cells and explore their functional utility when redirected to a target unrelated to YF. We performed single-cell TCR and mRNA sequencing on YF-specific CD8+ T cells from five vaccinated donors, 21 days post-vaccination to characterize their clonal diversity and transcriptional profiles. An HLA-restricted bispecific T cell engager, Redirector of Vaccine-induced Effector Responses (RoVER), was used to redirect YF-specific CD8+ T cells toward target cells including HIV-1-infected CD4+ T cells and CD19+ B cells. The vaccine elicited a robust CD8+ T cell response characterized by a diverse set of differentiated YF-specific cells spanning activated naïve-like, memory and effector phenotypes. Despite biases in the TCR repertoires, antigen-specificity did not promote the development of unique phenotypes following vaccination. Our findings suggest phenotypic overlap causing redundancy in CD8+ T cell immunity across YF epitopes. Using the recombinant RoVER, YF-specific CD8+ T cells could be redirected toward other target cells, leading to efficient target cell elimination. Together, this study enhances our understanding of the cytotoxic T cell response to viral infections and its implications for vaccine development, while also supporting the development of personalised immunotherapies tailored to individual HLA alleles.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"66 ","pages":"Article 127851"},"PeriodicalIF":4.5,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145305155","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 : 2025-10-14DOI: 10.1016/j.vaccine.2025.127843
Courteney Collins , Lufuno Ratshisusu , Lorato M. Modise , Omphile E. Simani , Selokela G. Selabe , Rudzani Muloiwa , Julie Copelyn , Edina Amponsah-Dacosta
{"title":"Hepatitis B virus infection and vaccine coverage among children living with HIV, HIV-exposed uninfected, and HIV-unexposed uninfected children in the Western Cape, South Africa","authors":"Courteney Collins , Lufuno Ratshisusu , Lorato M. Modise , Omphile E. Simani , Selokela G. Selabe , Rudzani Muloiwa , Julie Copelyn , Edina Amponsah-Dacosta","doi":"10.1016/j.vaccine.2025.127843","DOIUrl":"10.1016/j.vaccine.2025.127843","url":null,"abstract":"<div><h3>Background</h3><div>Limited evidence on the burden of hepatitis B virus (HBV) infection among children living with HIV (CLWH), HIV-exposed uninfected (HEU) and HIV-unexposed uninfected (HUU) children hinders progress towards eliminating hepatitis B.</div></div><div><h3>Methods</h3><div>This study used secondary data and archival sera (<em>N</em> = 671) from children <13 years old attending health facilities in the Western Cape, South Africa. Hepatitis B vaccine coverage was assessed using vaccination records for doses 1 to 3 by 12 months of age. Timely uptake was defined as receipt of a dose from 4 days before to 28 days after the recommended age. Serological markers of infection and immunity were measured using Elecsys® test kits (Roche Diagnostics, Germany). Logistic regression was performed to assess factors associated with incomplete and delayed vaccination.</div></div><div><h3>Results</h3><div>Coverage with all three doses by 12 months was 86.7 % (13/15), 80.9 % (263/325), and 77.0 % (57/74) for CLWH, HUU, and HEU, respectively. Hepatitis B vaccine coverage decreased across all subgroups as the schedule progressed. The highest proportion of delayed uptake for the third dose was noted among CLWH at 23.1 % (3/13), followed by 21.6 % (58/269) among HUU and 15.3 % (9/59) among HEU children (<em>p</em> = 0.540). Median delay for dose 3 was longest among CLWH (11.3 weeks) compared to HUU (6.7 weeks) (<em>p</em> = 0.368). HBV infection was detected in 1.4 % (1/74) of HEU and 0.3 % (1/328) of HUU children, with no cases among CLWH. Factors associated with completing the third dose included crèche attendance, lower-middle socio-economic status (SES), timely uptake of dose 1, participant's age, and HIV exposure status. Crèche attendance was associated with a lower likelihood of delayed uptake, while increasing age was associated with a higher likelihood of delay.</div></div><div><h3>Conclusion</h3><div>Our findings highlight disparities in timely hepatitis B vaccine uptake and coverage, emphasizing the need for targeted interventions ensuring timely vaccine uptake among HIV-exposed children.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"66 ","pages":"Article 127843"},"PeriodicalIF":4.5,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145305171","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 : 2025-10-14DOI: 10.1016/j.vaccine.2025.127836
Érique José Farias Peixoto de Miranda , José Alfredo de Sousa Moreira , Regiane da Silva Braga , Daniela Haydee Ramos Silveira , Vanessa Infante , Lucas Bassolli de Oliveira Alves , Juliana de Camargo Vieira Tenorio , Gabriel Ferreira dos Santos Silva , Elizabeth Gonzalez Patiño , Pedro Henrique Theotonio de Mesquita Pacheco , Fabiano Ramos , Danise Senna Oliveira , Esper Georges Kallás , Fernanda Castro Boulos
{"title":"Randomized, double-blind, placebo-controlled, phase 3 trial to demonstrate lot-to-lot consistency of 3 lots of the simplified formulation of Butantan-dengue vaccine","authors":"Érique José Farias Peixoto de Miranda , José Alfredo de Sousa Moreira , Regiane da Silva Braga , Daniela Haydee Ramos Silveira , Vanessa Infante , Lucas Bassolli de Oliveira Alves , Juliana de Camargo Vieira Tenorio , Gabriel Ferreira dos Santos Silva , Elizabeth Gonzalez Patiño , Pedro Henrique Theotonio de Mesquita Pacheco , Fabiano Ramos , Danise Senna Oliveira , Esper Georges Kallás , Fernanda Castro Boulos","doi":"10.1016/j.vaccine.2025.127836","DOIUrl":"10.1016/j.vaccine.2025.127836","url":null,"abstract":"<div><h3>Summary</h3><div>Background</div><div>We aimed to evaluate the consistency of the immune response on Day 28 postvaccination with three consecutive lots of simplified formulation of Butantan-Dengue Vaccine (Butantan-DV) and to describe the frequency of vaccine-related adverse events from vaccination through Day 21 postvaccination in comparison to placebo.</div></div><div><h3>Methods</h3><div>We included 700 participants allocated in a ratio 2:2:2:1 in parallel arms to receive any of three lots of simplified Butantan-DV or placebo, aged 18 to 59 years, without previous exposure to dengue in two study sites from a non-endemic area in Southern of Brazil. The consistency of three lots of the Butantan-DV were evaluated by analyzing the serum neutralizing antibody titers against four dengue virus serotypes by virus reduction neutralization test (VRNT<sub>60</sub>), on the Day 28 post-vaccination. Criterion for lot-to-lot consistency was two-sided 95 % confidence interval (95 % CI) of geometric mean titers (GMT) ratio within the margins of equivalence of >1/2 and < 2.0 for 12 possible pairwise comparison for the three lots and four serotypes in the Per-Protocol Set. Adverse events were analysed according to the frequency and Miettinen & Nurminen method to build 95 % CI for the difference in the binomial proportions of each lot with the placebo group. This trial is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT02406729</span><svg><path></path></svg></span>.</div></div><div><h3>Findings</h3><div>Between November 4th, 2022 and January 16th, 2023, 700 participants were randomized and vaccinated, while 607 (86.7 %) were included in the Per-Protocol Set. From the 12 possible pairwise comparison between three lots and four serotypes of DENV, 10 met the endpoint of equivalence of lots and 2 failed marginally. The overall frequency of vaccine-related adverse events was 90.8 % (544/599) in Butantan-DV group and 76 % (76/100) in placebo group.</div></div><div><h3>Interpretation</h3><div>Three lots of simplified formulation were safe and achieved the endpoint of equivalence of lots.</div></div><div><h3>Funding</h3><div>Intramural Research Program US NIH National Institute of Allergy and Infectious Diseases, Brazilian National Bank for Economic and Social Development, and Fundação Butantan.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"66 ","pages":"Article 127836"},"PeriodicalIF":4.5,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145305175","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 : 2025-10-14DOI: 10.1016/j.vaccine.2025.127839
Piet A. van Rijn , Ulrich Wernery , Arno-Jan Feddema , Mieke A. Maris-Veldhuis , Sunitha Joseph , René G.P. van Gennip
{"title":"Corrigendum to “Development of African horse sickness disabled infectious single animal (DISA)-DIVA vaccine platform applied for all nine serotypes” [Vaccine 64 (2025) 127772]","authors":"Piet A. van Rijn , Ulrich Wernery , Arno-Jan Feddema , Mieke A. Maris-Veldhuis , Sunitha Joseph , René G.P. van Gennip","doi":"10.1016/j.vaccine.2025.127839","DOIUrl":"10.1016/j.vaccine.2025.127839","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"66 ","pages":"Article 127839"},"PeriodicalIF":4.5,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145305141","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 : 2025-10-14DOI: 10.1016/j.vaccine.2025.127848
Alice S. Carter , Duncan Steele , Jacob John , Senjuti Saha , Matthew B. Laurens , Anna A. Minta , Litiana Volavola , Ismoedijanto Moedjito , Kongxay Phounphenghack , Diana Mahat , Soe Lwin Nyein , Abhiyan Gautam , Maria Fe Viviane S. Sespeñe , Teuila Pati , Nguyen Thi Thu Huong , Nivedita Gupta , Leyanna Susan George , Madhumathi Jayaprakasam , Anuradha Gupta , Denise O. Garrett
{"title":"Advancing typhoid conjugate vaccine implementation in Asia: Regional policy priorities","authors":"Alice S. Carter , Duncan Steele , Jacob John , Senjuti Saha , Matthew B. Laurens , Anna A. Minta , Litiana Volavola , Ismoedijanto Moedjito , Kongxay Phounphenghack , Diana Mahat , Soe Lwin Nyein , Abhiyan Gautam , Maria Fe Viviane S. Sespeñe , Teuila Pati , Nguyen Thi Thu Huong , Nivedita Gupta , Leyanna Susan George , Madhumathi Jayaprakasam , Anuradha Gupta , Denise O. Garrett","doi":"10.1016/j.vaccine.2025.127848","DOIUrl":"10.1016/j.vaccine.2025.127848","url":null,"abstract":"<div><div>Typhoid fever, a type of enteric fever transmitted through consumption of food or water contaminated with <em>Salmonella enterica</em> subspecies Typhi, continues to cause illness in Asia. Since the World Health Organization recommended use of typhoid conjugate vaccines in 2018, several countries have introduced or begun the decision-making process to use the vaccine in campaigns or by introduction into the routine immunization schedule. This paper describes the disease burden and vaccine implementation policy setting in the region, based on presentations and discussions at the second Asia Regional Meeting on Typhoid & TCV. Moving forward, typhoid control efforts must prioritize 1) working across health and finance ministries to finance vaccination programs, 2) strengthening surveillance to better understand disease burden, drug resistance trends, and vaccine impact, 3) developing improved diagnostic tests, 4) stewarding antimicrobial use to slow the spread of drug resistance, and 5) evaluating the durability of TCV protection.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"66 ","pages":"Article 127848"},"PeriodicalIF":4.5,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145305193","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}