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Measles second dose vaccination coverage and associated factors in Ethiopia: A systematic review and meta-analysis 埃塞俄比亚麻疹第二剂疫苗接种覆盖率及相关因素:系统回顾和荟萃分析
IF 2.7
Vaccine: X Pub Date : 2025-06-07 DOI: 10.1016/j.jvacx.2025.100675
Aklilu Alemayehu , Sisay Tefera
{"title":"Measles second dose vaccination coverage and associated factors in Ethiopia: A systematic review and meta-analysis","authors":"Aklilu Alemayehu ,&nbsp;Sisay Tefera","doi":"10.1016/j.jvacx.2025.100675","DOIUrl":"10.1016/j.jvacx.2025.100675","url":null,"abstract":"<div><h3>Background</h3><div>Measles-containing vaccine second dose (MCV2) is an important intervention employed to eliminate measles that mainly affect children. Although there are few original studies, comprehensive data that can guide evidence-based decision making to mitigate measles in Ethiopia is limited. Thus, this systematic review and meta-analysis aimed to synthesize evidence to fill this gap.</div></div><div><h3>Methods</h3><div>Online searching, selection, data extraction, and quality assessment were conducted by two authors. Data were extracted using Microsoft Excel Spreadsheet Version 19.0 and analyzed using STATA Version 17.0. Pooled estimates were determined by a random-effect meta-analysis. Sub-group analysis was conducted to account for sources of heterogeneity. Results are presented in narration, tables, and figures.</div></div><div><h3>Results</h3><div>Eight cross-sectional studies involving 4416 participants from four regions of Ethiopia were included in this SRMA. The pooled coverage of MCV2 vaccination in Ethiopia was 50.5 % [95 % confidence interval (CI): 39.0–61.9]. Maternal education [odds ratio (OR) = 2.14 95 % CI: 1.22–3.05)], child delivery in a health facility (OR = 2.16 95 % CI: 1.30–3.02), having knowledge about child immunization (OR = 2.24 95 % CI: 1.61–2.87), favorable attitude towards child immunization (OR = 4.30 95 % CI: 2.63–5.97), having awareness about MCV2 vaccination (OR = 2.04 95 % CI: 1.48–2.59), having postnatal follow-up (OR = 2.52 95 % CI: 1.39–3.65), and utilization of other vaccines and supplements (OR = 4.17 95 % CI: 2.05–6.28) were factors associated with MCV2 vaccination coverage.</div></div><div><h3>Conclusion</h3><div>The coverage of MCV2 vaccination in Ethiopia is sub-optimal. The identified factors should be targeted to improve MCV2 vaccination coverage, and hence strengthen measles mitigation.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100675"},"PeriodicalIF":2.7,"publicationDate":"2025-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144255342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exploring vaccination literacy and vaccine hesitancy in seven European countries: results from the HLS19 population survey 探索七个欧洲国家的疫苗接种素养和疫苗犹豫:来自HLS19人口调查的结果
IF 2.7
Vaccine: X Pub Date : 2025-06-02 DOI: 10.1016/j.jvacx.2025.100671
Bakary Cissé , Aldo Rosano , Robert Griebler , Brigid Unim , Chiara Lorini , Guglielmo Bonaccorsi , Mitja Vrdelja , Sophie Fégueux , Julien Mancini , Stephan Van den Broucke , For the HLS19 Consortium
{"title":"Exploring vaccination literacy and vaccine hesitancy in seven European countries: results from the HLS19 population survey","authors":"Bakary Cissé ,&nbsp;Aldo Rosano ,&nbsp;Robert Griebler ,&nbsp;Brigid Unim ,&nbsp;Chiara Lorini ,&nbsp;Guglielmo Bonaccorsi ,&nbsp;Mitja Vrdelja ,&nbsp;Sophie Fégueux ,&nbsp;Julien Mancini ,&nbsp;Stephan Van den Broucke ,&nbsp;For the HLS19 Consortium","doi":"10.1016/j.jvacx.2025.100671","DOIUrl":"10.1016/j.jvacx.2025.100671","url":null,"abstract":"<div><div>Improving Vaccine Literacy (VAC-HL) is a promise strategy to reduce vaccine hesitancy (VH). VAC-HL refers to the individual ability to access, understand, critically appraise, and apply vaccination-related information to make informed decisions about vaccinations for themselves or for others to be vaccinated. This study explores the pathways through which VAC-HL impacts VH.</div><div>The analysis was based on data from seven countries of the WHO European Region which implemented the Health Literacy Survey 2019–2021 (HLS<sub>19</sub>). VH was measured by a proxy for self-reported vaccination behaviour of respondents or their family members (e.g., children) over the past five years, while VAC-HL was assessed using four items stemming from the 47-item health literacy questionnaire used in HLS<sub>19</sub> (HLS<sub>19</sub>-Q47). A multilevel structural equation model was applied to examine the mediation role of vaccination attitudes - confidence, complacency, conspiracy beliefs - in the relationship between VAC-HL and VH, controlling for socio-economic confounding factors.</div><div>The results showed that individuals with high levels of VAC-HL are less likely to be unvaccinated (OR = 0.67, 95 % CI = 0.64–0.70). The inclusion of mediation variables in the model reduced slightly the association but it remained statistically significant (OR = 0.82, 95 % CI = 0.80–0.83). About 27.10 % of the association between VAC-HL and VH was mediated by confidence, 6.58 % by complacency and 17.30 % by conspiracy.</div><div>Enhancing VAC-HL might have a positive effect on restoring confidence in vaccination and reducing complacency and conspiracy beliefs, which are essential for improving vaccination uptake.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100671"},"PeriodicalIF":2.7,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144231717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to “Evaluation of a novel liquid stabilised peste des petits ruminants vaccine: Safety and immunogenic efficacy in sheep and goats in the field in Jordan” [Vaccine X 15 (2023) 100363] “评价一种新型液体稳定小反刍害虫疫苗:约旦田间绵羊和山羊的安全性和免疫原性效力”的勘误表[疫苗X 15 (2023) 100363]
IF 2.7
Vaccine: X Pub Date : 2025-06-01 DOI: 10.1016/j.jvacx.2025.100653
Fraser Crofts , Ahmad Al-Majali , David Gerring , Simon Gubbins , Matthew Tully , Hayley Hicks , Dana Campbell , Jeremy Salt , Steve Wilson , Lizzie Chesang , Kristin Stuke , Claudia Cordel , Satya Parida , Carrie Batten
{"title":"Corrigendum to “Evaluation of a novel liquid stabilised peste des petits ruminants vaccine: Safety and immunogenic efficacy in sheep and goats in the field in Jordan” [Vaccine X 15 (2023) 100363]","authors":"Fraser Crofts ,&nbsp;Ahmad Al-Majali ,&nbsp;David Gerring ,&nbsp;Simon Gubbins ,&nbsp;Matthew Tully ,&nbsp;Hayley Hicks ,&nbsp;Dana Campbell ,&nbsp;Jeremy Salt ,&nbsp;Steve Wilson ,&nbsp;Lizzie Chesang ,&nbsp;Kristin Stuke ,&nbsp;Claudia Cordel ,&nbsp;Satya Parida ,&nbsp;Carrie Batten","doi":"10.1016/j.jvacx.2025.100653","DOIUrl":"10.1016/j.jvacx.2025.100653","url":null,"abstract":"","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100653"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144221596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to “Immunization of children with inflammatory bowel disease against SARS-CoV-19 infection: A prospective single centre cohort study” [Vaccine:X 15 (2023) 100374] “炎性肠病儿童预防SARS-CoV-19感染的免疫接种:一项前瞻性单中心队列研究”的勘误表[疫苗:x15 (2023) 100374]
IF 2.7
Vaccine: X Pub Date : 2025-06-01 DOI: 10.1016/j.jvacx.2025.100652
Dóra Dohos , Anna Karoliny , Eszter Gombos , Éva Rimanóczy , Katalin E. Müller
{"title":"Corrigendum to “Immunization of children with inflammatory bowel disease against SARS-CoV-19 infection: A prospective single centre cohort study” [Vaccine:X 15 (2023) 100374]","authors":"Dóra Dohos ,&nbsp;Anna Karoliny ,&nbsp;Eszter Gombos ,&nbsp;Éva Rimanóczy ,&nbsp;Katalin E. Müller","doi":"10.1016/j.jvacx.2025.100652","DOIUrl":"10.1016/j.jvacx.2025.100652","url":null,"abstract":"","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100652"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144221681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to “Vaccination, information and parental confidence in the digital age in England” [Vaccine: X 14 (2023) 100345] “英格兰数字时代的疫苗接种、信息和父母信心”的勘误表[疫苗:X 14 (2023) 100345]
IF 2.7
Vaccine: X Pub Date : 2025-06-01 DOI: 10.1016/j.jvacx.2025.100651
H. Campbell , P. Paterson , L. Letley , V. Saliba , S. Mounier-Jack , J. Yarwood
{"title":"Corrigendum to “Vaccination, information and parental confidence in the digital age in England” [Vaccine: X 14 (2023) 100345]","authors":"H. Campbell ,&nbsp;P. Paterson ,&nbsp;L. Letley ,&nbsp;V. Saliba ,&nbsp;S. Mounier-Jack ,&nbsp;J. Yarwood","doi":"10.1016/j.jvacx.2025.100651","DOIUrl":"10.1016/j.jvacx.2025.100651","url":null,"abstract":"","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100651"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144221591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to “COVID-19 vaccine eligibility of pregnant and lactating women in Bangladesh: Gap between policy and policy interpretation among policymakers and healthcare workers” [Vaccine: X 15 (2023) 100370] “孟加拉国孕妇和哺乳期妇女COVID-19疫苗接种资格:政策制定者和卫生保健工作者之间的政策和政策解释之间的差距”的勘误表[疫苗:X 15 (2023) 100370]
IF 2.7
Vaccine: X Pub Date : 2025-06-01 DOI: 10.1016/j.jvacx.2025.100649
Rupali J. Limaye , Berhaun Fesshaye , Prachi Singh , Eleonor Zavala , Shirina Akter , Towfida Jahan Siddiqua , Hafizur Rahman , Hasmot Ali , Ruth Karron
{"title":"Corrigendum to “COVID-19 vaccine eligibility of pregnant and lactating women in Bangladesh: Gap between policy and policy interpretation among policymakers and healthcare workers” [Vaccine: X 15 (2023) 100370]","authors":"Rupali J. Limaye ,&nbsp;Berhaun Fesshaye ,&nbsp;Prachi Singh ,&nbsp;Eleonor Zavala ,&nbsp;Shirina Akter ,&nbsp;Towfida Jahan Siddiqua ,&nbsp;Hafizur Rahman ,&nbsp;Hasmot Ali ,&nbsp;Ruth Karron","doi":"10.1016/j.jvacx.2025.100649","DOIUrl":"10.1016/j.jvacx.2025.100649","url":null,"abstract":"","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100649"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144221590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Enablers and barriers to older women's support of infant immunization timeliness and completion in selected urban slum communities of Ibadan, Nigeria 在尼日利亚伊巴丹选定的城市贫民窟社区,老年妇女支持婴儿免疫接种及时性和完成的促进因素和障碍
IF 2.7
Vaccine: X Pub Date : 2025-05-27 DOI: 10.1016/j.jvacx.2025.100668
Folusho Mubowale Balogun , Olubukola Christianah Omobowale , Abimbola Ellen Akindolire
{"title":"Enablers and barriers to older women's support of infant immunization timeliness and completion in selected urban slum communities of Ibadan, Nigeria","authors":"Folusho Mubowale Balogun ,&nbsp;Olubukola Christianah Omobowale ,&nbsp;Abimbola Ellen Akindolire","doi":"10.1016/j.jvacx.2025.100668","DOIUrl":"10.1016/j.jvacx.2025.100668","url":null,"abstract":"<div><h3>Background</h3><div>Infant immunization coverage remains suboptimal in Nigeria, especially in the rural and urban slum areas. There have been efforts to improve immunization coverage, but the outcomes are not satisfactory. In many African families, older women significantly influence childcare decisions, and this influence may be channeled to improve infant vaccination. This study investigated the enablers and barriers to older women's support of infant immunization timeliness and completion in selected urban slum communities of Ibadan, Nigeria.</div></div><div><h3>Methods</h3><div>An exploratory cross-sectional qualitative study was conducted in eight urban slum communities. Older women's opinions about their roles in infant immunization timeliness and completion were explored using focus group discussions (FGDs). Data were analyzed using content analysis based on the Theoretical Domains Framework.</div></div><div><h3>Results</h3><div>175 women aged 35–80 years participated in 22 FGDs. Enablers of support for infant immunization include the older women's cognitive and interpersonal skills in supporting young mothers, their positive social influence on grandchildren's immunization, and their belief that complete immunization prevents childhood illnesses and death. Barriers included incomplete knowledge of vaccination schedules, vaccine stockouts, poorly behaved health workers, long waiting times at clinics, and adverse experiences following immunization. The role of older women in mentoring, educating, reminding, and supporting parents was recognized as critical for improving vaccination rates.</div></div><div><h3>Conclusions</h3><div>The older women possessed valuable capabilities, opportunities, and motivations that can be leveraged to improve infant immunization. However, they need improvement in the knowledge of immunization schedules and the identified health system barriers should be addressed.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100668"},"PeriodicalIF":2.7,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144184480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of passive immunity from dams previously immunized with an inactivated glycoprotein E-deleted infectious bovine rhinotracheitis marker vaccine after challenge infection with wild-type bovine alphaherpesvirus 1 in calves 小牛攻毒感染野生型牛α疱疹病毒1后,用糖蛋白e缺失灭活的感染性牛鼻气管炎标记疫苗免疫的母牛被动免疫的评价
IF 2.7
Vaccine: X Pub Date : 2025-05-27 DOI: 10.1016/j.jvacx.2025.100670
Stefano Petrini , Alessandra Martucciello , Cecilia Righi , Giovanna Cappelli , Giulia Costantino , Carlo Grassi , Cristina Casciari , Eleonora Scoccia , Elena Tinelli , Giorgio Galiero , Monica Giammarioli , Esterina De Carlo , Roberto Sabato , Francesco Feliziani
{"title":"Evaluation of passive immunity from dams previously immunized with an inactivated glycoprotein E-deleted infectious bovine rhinotracheitis marker vaccine after challenge infection with wild-type bovine alphaherpesvirus 1 in calves","authors":"Stefano Petrini ,&nbsp;Alessandra Martucciello ,&nbsp;Cecilia Righi ,&nbsp;Giovanna Cappelli ,&nbsp;Giulia Costantino ,&nbsp;Carlo Grassi ,&nbsp;Cristina Casciari ,&nbsp;Eleonora Scoccia ,&nbsp;Elena Tinelli ,&nbsp;Giorgio Galiero ,&nbsp;Monica Giammarioli ,&nbsp;Esterina De Carlo ,&nbsp;Roberto Sabato ,&nbsp;Francesco Feliziani","doi":"10.1016/j.jvacx.2025.100670","DOIUrl":"10.1016/j.jvacx.2025.100670","url":null,"abstract":"<div><div>Bovine alphaherpesvirus 1 (BoAHV-1) is a major cattle pathogen that causes infectious bovine rhinotracheitis (IBR) and other respiratory and reproductive disorders, resulting in substantial global economic losses to the cattle industry. Although glycoprotein E (gE)-deleted IBR marker vaccines are widely used to manage BoAHV-1, the protective efficacy of passive immunity in dams vaccinated with these vaccines remains unclear. In this study, we aimed to test the hypothesis that passive immunity transferred from dams previously vaccinated with an inactivated gE-deleted IBR marker vaccine protects calves against wild-type (wt) BoAHV-1. To test this hypothesis, we conducted an experiment in which 12 calves aged 3–6 months were divided into four groups (A, B, C, and D). Calves in groups A and C were immunized with neutralizing antibodies derived from passive immunity at titers of 1.00 log<sub>10</sub> and 1.61 log<sub>10</sub>, respectively. Groups B and D represent negative controls. All calves were challenged with BoAHV-1, and the clinical scores and rectal temperatures were recorded at different time points after the challenge. Nasal swabs and blood samples were collected for virological and serological investigations, respectively. The findings did not support our hypothesis, as typical clinical signs, viremia, and immunological responses to IBR were observed in all groups. In summary, these findings demonstrate that passive immunity does not protect calves from wt BoAHV-1 infection, suggesting the necessity of future studies to develop appropriate vaccination strategies for calves with passive immunity to protect them against wt BoAHV-1.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100670"},"PeriodicalIF":2.7,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144195582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optimization and application of a mouse challenge model for Mumps virus 小鼠腮腺炎病毒攻毒模型的优化与应用
IF 2.7
Vaccine: X Pub Date : 2025-05-26 DOI: 10.1016/j.jvacx.2025.100665
Yajing Zhang , Benjie Chai , Fei Huang , Biao Niu , Yangyang Liu , Pengpeng Zhou , Hui Wang , Yue Guo , Zhenfang Fu , Qi An , Dayong Tian
{"title":"Optimization and application of a mouse challenge model for Mumps virus","authors":"Yajing Zhang ,&nbsp;Benjie Chai ,&nbsp;Fei Huang ,&nbsp;Biao Niu ,&nbsp;Yangyang Liu ,&nbsp;Pengpeng Zhou ,&nbsp;Hui Wang ,&nbsp;Yue Guo ,&nbsp;Zhenfang Fu ,&nbsp;Qi An ,&nbsp;Dayong Tian","doi":"10.1016/j.jvacx.2025.100665","DOIUrl":"10.1016/j.jvacx.2025.100665","url":null,"abstract":"<div><div>Mumps is an acute respiratory infectious disease that occasionally experiences outbreaks even in countries with high vaccination rates. This indicates potential antigenic differences between currently available vaccine strains and circulating wild-type viruses. Therefore, it is crucial to evaluate the vaccine's protective efficacy against the epidemic strain. In this study, we injected IFN-α/βR<sup>−/−</sup> mice with genotype F or G wild-type strains via the tail vein. The mumps virus rapidly replicated and maintained high levels in the blood. Furthermore, prior immunization of IFN-α/βR<sup>−/−</sup> mice with vaccine strain significantly inhibited viral replication in vivo. Consequently, we have optimized a valuable model for assessing the effectiveness of MuV vaccines.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100665"},"PeriodicalIF":2.7,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144178224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A multi-centre, single arm, Phase 3 study to assess the safety and reactogenicity of biological Es Vi-capsular polysaccharide-CRM197 conjugate typhoid vaccine in ≥6 months old infants to ≤45 years old adults. 一项多中心、单组、3期研究,评估生物Es vi -荚膜多糖- crm197结合伤寒疫苗在≥6个月婴儿至≤45岁成人中的安全性和反应原性。
IF 2.7
Vaccine: X Pub Date : 2025-05-24 DOI: 10.1016/j.jvacx.2025.100669
Subhash Thuluva , Ramesh V. Matur , Subbareddy Gunneri , Vijay Yerroju , Rammohan Reddy Mogulla , Chirag Dhar , Raju Esanakarra , Savita Verma , Manish Narang , Madhukar Pandey
{"title":"A multi-centre, single arm, Phase 3 study to assess the safety and reactogenicity of biological Es Vi-capsular polysaccharide-CRM197 conjugate typhoid vaccine in ≥6 months old infants to ≤45 years old adults.","authors":"Subhash Thuluva ,&nbsp;Ramesh V. Matur ,&nbsp;Subbareddy Gunneri ,&nbsp;Vijay Yerroju ,&nbsp;Rammohan Reddy Mogulla ,&nbsp;Chirag Dhar ,&nbsp;Raju Esanakarra ,&nbsp;Savita Verma ,&nbsp;Manish Narang ,&nbsp;Madhukar Pandey","doi":"10.1016/j.jvacx.2025.100669","DOIUrl":"10.1016/j.jvacx.2025.100669","url":null,"abstract":"<div><h3>Background</h3><div>Typhoid fever is a serious bacterial infection caused by <em>Salmonella Typhi</em>, with a significant burden in low- and middle-income countries, particularly in Sub-Saharan Africa and South/Southeast Asia. To mitigate its spread, the World Health Organization (WHO) advocates for typhoid vaccination programs that particularly target high-risk populations. However, unconjugated polysaccharide vaccines have shown limited efficacy in children under two years of age.</div><div>Biological E has developed a typhoid conjugate vaccine, TYPHIBEV®, which incorporates the Vi-polysaccharide conjugated to the CRM<sub>197</sub> carrier protein. TYPHIBEV®’s safety and immunogenicity were evaluated in Phase 1 and Phase 2/3 clinical trials involving infants, children, adolescents, and adults, compared to an established licensed vaccine. This Phase 3 study was specifically designed to assess the safety profile of TYPHIBEV® in the target population aged ≥6 months to ≤45 years.</div></div><div><h3>Methods</h3><div>A multi-centre, single-arm, non-comparative Phase 3 study was conducted to evaluate the safety, tolerability and reactogenicity of a single intramuscular dose of Biological E's Vi-capsular Polysaccharide-CRM<sub>197</sub> Conjugate Typhoid Vaccine. A total of 1770 subjects were enrolled into three age subsets; infants and toddlers, ≥6 months to &lt;2 years of age; children and adolescents, ≥2 years to &lt;18 years of age; and adults, ≥18 years to ≤45 years of age (<em>n</em> = 590 in each age group). A single dose of THPHIBEV® was administered, and all the subjects were followed up for a period of 42 days. Solicited local and systemic AEs were recorded up until 7 days post-vaccination. Unsolicited AEs, serious AEs (SAEs), and medically attended AEs (MAAEs) were recorded throughout the study duration.</div></div><div><h3>Findings</h3><div>A total of 114 AEs were recorded in 101 (5.71 %) participants. A majority of these AEs were solicited in nature with general disorders and administration site conditions reported in 5.42 % of participants. The most commonly reported AEs were injection site pain and pyrexia. All MAAEs (1.30 % subjects) were solicited and pyrexia (0.85 % of subjects) was the most common reason for medical attention. No severe or serious AEs and/or deaths were reported throughout the study. None of the subjects discontinued the study due to an AE.</div></div><div><h3>Conclusions</h3><div>TYPHIBEV® was found to be safe and well tolerated across different age groups and the safety profile was comparable to other TCVs in terms of reported solicited and unsolicited AEs. No severe or serious AEs were reported during the entire study period.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100669"},"PeriodicalIF":2.7,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144167292","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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