Vaccine: X最新文献

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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
Comparative effectiveness of live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in children over multiple influenza seasons (2019–2023) 2019-2023年多个流感季节儿童流感减毒活疫苗(LAIV)与灭活疫苗(iv)效果比较
IF 2.7
Vaccine: X Pub Date : 2025-05-24 DOI: 10.1016/j.jvacx.2025.100666
Allyn Bandell , George Kassianos , Oliver Dibben , Georges El Azzi
{"title":"Comparative effectiveness of live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in children over multiple influenza seasons (2019–2023)","authors":"Allyn Bandell ,&nbsp;George Kassianos ,&nbsp;Oliver Dibben ,&nbsp;Georges El Azzi","doi":"10.1016/j.jvacx.2025.100666","DOIUrl":"10.1016/j.jvacx.2025.100666","url":null,"abstract":"<div><div>Vaccine effectiveness (VE) of quadrivalent live attenuated influenza vaccine (LAIV4) and quadrivalent inactivated influenza vaccine (IIV4) in children in 13 European countries and the US during the 2019–2023 influenza seasons was evaluated from published literature, congress presentations, public health websites, and personal communications with investigators.</div><div>A meta-analysis was performed by assessing LAIV4 and/or IIV4 VE in children (<em>N</em> = 34–1679) across included studies during the 2019/20–2022/23 seasons. VE estimates against influenza infection (all strains) for LAIV4 were 61.9 % (95 % confidence interval [CI]: 53.0–69.1) and for IIV4 were 45.7 % (33.2–55.8). Overall VE (95 % CI) for individual strains for the 2022/23 season for LAIV4 were 75.7 % (52.0–87.7) and for IIV4 were 58.5 % (38.2–72.1).</div><div>Overall, LAIV4 and IIV4 VE in children was moderate and comparable. Annual vaccination with LAIV4 or IIV4 remains the best way to protect children against influenza infection.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100666"},"PeriodicalIF":2.7,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144189722","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
Serological evaluation of the immune protection conferred by the canine parvovirus vaccine: A comparative study of a recommended brief protocol and WSAVA protocols 犬细小病毒疫苗免疫保护的血清学评价:推荐的简要方案和WSAVA方案的比较研究
IF 2.7
Vaccine: X Pub Date : 2025-05-22 DOI: 10.1016/j.jvacx.2025.100667
Idbarka Abdellatif , Kadim Oumaima , Soulhi Imane , Piro Mohammed , Amrani Nadia , Azrib Rahma , Kadiri Ahlam , Daden Reda , El Allali Khalid
{"title":"Serological evaluation of the immune protection conferred by the canine parvovirus vaccine: A comparative study of a recommended brief protocol and WSAVA protocols","authors":"Idbarka Abdellatif ,&nbsp;Kadim Oumaima ,&nbsp;Soulhi Imane ,&nbsp;Piro Mohammed ,&nbsp;Amrani Nadia ,&nbsp;Azrib Rahma ,&nbsp;Kadiri Ahlam ,&nbsp;Daden Reda ,&nbsp;El Allali Khalid","doi":"10.1016/j.jvacx.2025.100667","DOIUrl":"10.1016/j.jvacx.2025.100667","url":null,"abstract":"<div><div>Canine parvovirus (CPV) is a highly contagious and often fatal viral disease in puppies, with high morbidity and mortality rates. Despite vaccination, failures have been reported, especially with the short protocol (BP) recommended by some pharmaceutical companies, which may not align with the World Small Animal Veterinary Association (WSAVA) 2024 guidelines.</div><div>This study aimed to evaluate the effectiveness of immunity in puppies vaccinated with the BP protocol and assess whether boosters based on the WSAVA guidelines would improve immunity. Experiment 1 involved unvaccinated puppies receiving the WSAVA vaccination protocol, with four vaccinations at 15-day intervals. Experiment 2 assessed puppies vaccinated with the BP protocol, followed by two additional booster doses administered two weeks apart.</div><div>In Experiment 1, puppies receiving the WSAVA protocol had insufficient maternal antibodies (32.00 ± 14.99) at 12–16 weeks. After four vaccinations, antibody titers significantly increased to 256.00 ± 79.43 by day 45 (<em>p = 0.0166</em>). In Experiment 2, puppies vaccinated with the BP protocol showed antibody titers of 32.00 ± 32.57 at 5 months, below the protective threshold. Two additional boosters raised antibody titers to 512.00 ± 245.0 at day 45 (<em>p = 0.0154</em>). These results indicate that the BP protocol alone does not provide adequate immunity but that Additional boosters can improve immunity. The WSAVA vaccination protocol effectively protects against CPV, while the BP protocol requires additional boosters to meet protective standards. Implementing WSAVA-guideline-based boosters is essential to improve CPV protection in puppies.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100667"},"PeriodicalIF":2.7,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144167411","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 for the production of a dengue live-attenuated Quadrivalent vaccine in Vero cells grown on microcarriers 在微载体上生长的Vero细胞中优化生产登革热减毒四价活疫苗
IF 2.7
Vaccine: X Pub Date : 2025-05-21 DOI: 10.1016/j.jvacx.2025.100658
Shannon Haughney , Seth Clark , Elizabeth Carey , Nelson Lee Afanador , Victoria Stabile , Bernard Kang , Samantha Marrone , Jillian Shingler , Carl Hofmann , Christopher J. Wang , Christopher Ton
{"title":"Optimization for the production of a dengue live-attenuated Quadrivalent vaccine in Vero cells grown on microcarriers","authors":"Shannon Haughney ,&nbsp;Seth Clark ,&nbsp;Elizabeth Carey ,&nbsp;Nelson Lee Afanador ,&nbsp;Victoria Stabile ,&nbsp;Bernard Kang ,&nbsp;Samantha Marrone ,&nbsp;Jillian Shingler ,&nbsp;Carl Hofmann ,&nbsp;Christopher J. Wang ,&nbsp;Christopher Ton","doi":"10.1016/j.jvacx.2025.100658","DOIUrl":"10.1016/j.jvacx.2025.100658","url":null,"abstract":"<div><div>Dengue is a mosquito-borne disease and is a major global health threat, especially in tropical and subtropical regions. In this study, we describe the optimization of virus production for a dengue live-attenuated quadrivalent vaccine candidate and demonstrate scalability of a stirred tank bioreactor serum-free microcarrier process. We utilized a design-of-experiment (DoE) methodology to optimize for pH and temperature and evaluate effect of Multiplicity of Infection (MOI) and Time of Infection (TOI) for each serotype during virus production in 2 L and 3 L bioreactors. The optimal pH and temperature for dengue virus production achieved ∼10× higher virus titer at peak virus production for all 4 serotypes compared to baseline condition. Different MOI and TOI did not impact peak virus production. Results from the DoE studies were successfully scaled to the 50 L Single-Use Bioreactor (SUB).</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100658"},"PeriodicalIF":2.7,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144105415","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
Immunogenicity, safety and tolerability of 15-valent pneumococcal conjugate vaccine (V114) compared to 13-valent pneumococcal conjugate vaccine (PCV-13) in healthy infants: A systematic review and meta-analysis 15价肺炎球菌结合疫苗(V114)与13价肺炎球菌结合疫苗(PCV-13)在健康婴儿中的免疫原性、安全性和耐受性:一项系统综述和荟萃分析
IF 2.7
Vaccine: X Pub Date : 2025-05-21 DOI: 10.1016/j.jvacx.2025.100654
Muhammad Zain Ul Haq , Hamza Irfan , Muhammad Shahmeer Ullah Shah , Anusha Sumbal , Sanila Mughal , Saad Ashraf , Areeba Aamir Ali Basaria , Abdullah , Muhammad Aaqib Chacho , Biruk Demisse Ayalew
{"title":"Immunogenicity, safety and tolerability of 15-valent pneumococcal conjugate vaccine (V114) compared to 13-valent pneumococcal conjugate vaccine (PCV-13) in healthy infants: A systematic review and meta-analysis","authors":"Muhammad Zain Ul Haq ,&nbsp;Hamza Irfan ,&nbsp;Muhammad Shahmeer Ullah Shah ,&nbsp;Anusha Sumbal ,&nbsp;Sanila Mughal ,&nbsp;Saad Ashraf ,&nbsp;Areeba Aamir Ali Basaria ,&nbsp;Abdullah ,&nbsp;Muhammad Aaqib Chacho ,&nbsp;Biruk Demisse Ayalew","doi":"10.1016/j.jvacx.2025.100654","DOIUrl":"10.1016/j.jvacx.2025.100654","url":null,"abstract":"<div><h3>Introduction</h3><div><em>Streptococcus pneumoniae</em> is a major cause of infectious diseases, particularly in children under 5, leading to approximately 300,000 deaths annually. The introduction of pneumococcal conjugate vaccines (PCVs), such as PCV13, has significantly reduced invasive pneumococcal disease (IPD). However, rising cases of IPD caused by non-vaccine serotypes highlight the need for broader coverage vaccines like PCV15 (V114). This study aims to evaluate the immunogenicity and safety of V114 compared to PCV13 in healthy infants.</div></div><div><h3>Methods</h3><div>This systematic review and meta-analysis followed PRISMA guidelines and was registered with PROSPERO (CRD42024576730). Two reviewers searched MEDLINE, Google Scholar, and Cochrane databases for randomized controlled trials (RCTs) comparing V114 and PCV13 in infants. Data were extracted on immunogenicity (IgG response and geometric mean concentration) and safety outcomes. Meta-regression was conducted using R software for variables where heterogeneity could not be explained through subgroup analysis or leave-one-out analysis.</div></div><div><h3>Results</h3><div>A total of 11 RCTs involving 9970 infants were included. Immunogenicity results indicated higher seropositivity for shared serotypes in PCV13, while V114 showed superior responses for unique serotypes (22F and 33F). No significant differences in overall adverse effects were observed between the two vaccines, although injection-site pain was more common with V114 and urticaria was noted more frequently with PCV13.</div></div><div><h3>Conclusion</h3><div>V114 demonstrated enhanced immunogenicity for certain serotypes and comparable safety profiles to PCV13. The findings support the potential of V114 to address the limitations of current vaccines, particularly against non-vaccine serotypes. Further research is necessary to evaluate long-term immunity and real-world effectiveness.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100654"},"PeriodicalIF":2.7,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144124713","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
Cost-utility analysis of current COVID-19 vaccination program recommendations in Canada 加拿大目前COVID-19疫苗接种计划建议的成本效用分析
IF 2.7
Vaccine: X Pub Date : 2025-05-21 DOI: 10.1016/j.jvacx.2025.100660
Alison E. Simmons , Rafael N. Miranda , Michael W.Z. Li , Gebremedhin B. Gebretekle , Min Xi , Marina I. Salvadori , Bryna Warshawsky , Eva Wong , Raphael Ximenes , Melissa K. Andrew , Sarah Wilson , Matthew Tunis , Ashleigh R. Tuite
{"title":"Cost-utility analysis of current COVID-19 vaccination program recommendations in Canada","authors":"Alison E. Simmons ,&nbsp;Rafael N. Miranda ,&nbsp;Michael W.Z. Li ,&nbsp;Gebremedhin B. Gebretekle ,&nbsp;Min Xi ,&nbsp;Marina I. Salvadori ,&nbsp;Bryna Warshawsky ,&nbsp;Eva Wong ,&nbsp;Raphael Ximenes ,&nbsp;Melissa K. Andrew ,&nbsp;Sarah Wilson ,&nbsp;Matthew Tunis ,&nbsp;Ashleigh R. Tuite","doi":"10.1016/j.jvacx.2025.100660","DOIUrl":"10.1016/j.jvacx.2025.100660","url":null,"abstract":"<div><h3>Background</h3><div>As COVID-19 becomes established as an endemic disease with widespread population immunity, there is uncertainty about the economic benefit of ongoing COVID-19 vaccination programs. We assessed the cost-effectiveness of a COVID-19 vaccination program similar to current Canadian recommendations, modelled as annual vaccination for people aged less than 65 years with chronic medical conditions and biannual vaccination for adults aged 65 years and older.</div></div><div><h3>Methods</h3><div>Using a static individual-based model of medically attended COVID-19 in a population of one million people, we estimated costs (in 2023 Canadian dollars), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). We used health system and societal perspectives and a 1.5 % discount rate. Parameters were based on recent COVID-19 epidemiology, vaccine characteristics, and costs.</div></div><div><h3>Results</h3><div>Between July 2024 and September 2025, a program similar to current Canadian recommendations was estimated to avert 3.1 % (95 % credible interval (CrI): 3.0 to 3.2 %) of outpatient cases, 8.8 % (95 % CrI: 7.3 to 10.4 %) of inpatient cases, 3.6 % (95 % CrI: 2.8 to 4.3 %) of PCC cases, and 9.4 % (95 % CrI: 5.6 to 13.8 %) of deaths compared to no vaccination. The number needed to vaccinate to prevent one hospitalization and one death was 1121 (95 % CrI: 941 to 1357) and 8656 (95 % CrI: 5848 to 14,915), respectively. For the health system perspective, the program would cost an additional $4.695 million but result in 221.17 QALYs gained, leading to an ICER of $21,227 per QALY compared to no vaccination. Vaccine price influenced cost-effectiveness, with higher prices reducing the likelihood the program met common cost-effectiveness thresholds.</div></div><div><h3>Conclusions</h3><div>A program similar to current COVID-19 recommendations in Canada is likely effective and cost-effective compared to no vaccination. However, unlike some other research studies, alternate vaccination strategies that may offer better value for money were not evaluated.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100660"},"PeriodicalIF":2.7,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144124686","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
One-month evaluation of safety and immunogenicity of a Vi-DT typhoid conjugate vaccine (Bio-TCV®) in Indonesian subjects 6 months to 45 years: A phase III randomized clinical trial 6个月至45岁印度尼西亚受试者中Vi-DT伤寒结合疫苗(Bio-TCV®)一个月的安全性和免疫原性评估:一项III期随机临床试验
IF 2.7
Vaccine: X Pub Date : 2025-05-20 DOI: 10.1016/j.jvacx.2025.100661
Bernie Endyarni Medise , I. Gusti Ayu Trisna Windiani , Dominicus Husada , Rini Sekartini , Hartono Gunardi , Angga Wirahmadi , Dwiyanti Puspitasari , Leny Kartina , I. Gusti Agung Ngurah Sugitha Adnyana , I. Gusti Lanang Sidiartha , I. Made Dwi Lingga Utama , I. Ketut Agus Somia , Iris Rengganis , Sukamto Koesnoe , Hindra Irawan Satari , Soedjatmiko Soedjatmiko , Sri Rezeki Hadinegoro , Ismoedijanto Ismoedijanto , Parwati Setiono Basuki , Gatot Soegiarto , Sushant Sahastrabuddhe
{"title":"One-month evaluation of safety and immunogenicity of a Vi-DT typhoid conjugate vaccine (Bio-TCV®) in Indonesian subjects 6 months to 45 years: A phase III randomized clinical trial","authors":"Bernie Endyarni Medise ,&nbsp;I. Gusti Ayu Trisna Windiani ,&nbsp;Dominicus Husada ,&nbsp;Rini Sekartini ,&nbsp;Hartono Gunardi ,&nbsp;Angga Wirahmadi ,&nbsp;Dwiyanti Puspitasari ,&nbsp;Leny Kartina ,&nbsp;I. Gusti Agung Ngurah Sugitha Adnyana ,&nbsp;I. Gusti Lanang Sidiartha ,&nbsp;I. Made Dwi Lingga Utama ,&nbsp;I. Ketut Agus Somia ,&nbsp;Iris Rengganis ,&nbsp;Sukamto Koesnoe ,&nbsp;Hindra Irawan Satari ,&nbsp;Soedjatmiko Soedjatmiko ,&nbsp;Sri Rezeki Hadinegoro ,&nbsp;Ismoedijanto Ismoedijanto ,&nbsp;Parwati Setiono Basuki ,&nbsp;Gatot Soegiarto ,&nbsp;Sushant Sahastrabuddhe","doi":"10.1016/j.jvacx.2025.100661","DOIUrl":"10.1016/j.jvacx.2025.100661","url":null,"abstract":"<div><h3>Background</h3><div>Typhoid fever typically affects children and young adults and is a considerable cause of morbidity and mortality. Vaccination is the most effective preventive strategy to control typhoid fever in the short to medium term. However, in most endemic countries do not have a typhoid vaccine that is suitable for children below 2 years old.</div></div><div><h3>Methods</h3><div>This is a randomized, observer blinded phase III trial using Vi-DT typhoid conjugate vaccine and an already WHO licensed prequalified (PQed) typhoid conjugate vaccine (Typbar TCV) as control. About 936 healthy subjects were recruited and divided into 3 age groups: infants group aged 6–24 months, children group aged 2–11 years, adolescents and adults group aged 12–45 years, and followed up till 28 days post vaccination. Blood sample was taken at pre-vaccination and at 28th day post vaccination to evaluate immunogenicity.</div></div><div><h3>Results</h3><div>The most common immediate local reaction was pain in all age groups, followed by redness. The most common immediate systemic reaction in the infant group was irritability while in the adults and children group was muscle pain. The intensity of reactions was mostly mild and moderate. Severe reactions were in the form of pain and fever. Reactions mostly resolved within 48 h. Seroconversion at 28 days in the Vi-DT group was higher in both adults and children compared to the PQed typhoid conjugate vaccine, Typbar-TCV (<em>p</em> = 1.000; <em>p</em> = 0.250), respectively. The Geometric Mean Titer (GMT) in the Vi-DT group was higher in adults (<em>p</em> = 0134), whereas the PQed typhoid conjugate vaccine Typbar-TCV demonstrated a higher GMT in children and infants (<em>p</em> = 0.277; <em>p</em> = 0.884), respectively.</div></div><div><h3>Conclusion</h3><div>Vi-DT typhoid conjugate vaccine (Bio-TCV®) is safe and immunogenic in subjects 6 months to 45 years old.</div><div>Clinical trial registration number.</div><div><span><span>NCT04051268</span><svg><path></path></svg></span>, registration date: 09/08/2019.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100661"},"PeriodicalIF":2.7,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144167410","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
Adolescent vaccine introductions scoping review: A decade of insights from low- and middle-income countries (2013−2023) 青少年疫苗引进范围审查:低收入和中等收入国家十年的见解(2013 - 2023年)
IF 2.7
Vaccine: X Pub Date : 2025-05-20 DOI: 10.1016/j.jvacx.2025.100657
Arman Majidulla , Amelia K. Gerste , Anurima Baidya , Onimitein Georgewill , Kirthini K. Muralidharan , Degu J. Dare , Joeri S. Buis , Michelle M. Gill , Julie A. Denison , Andrew D. Kerkhoff , Rupali J. Limaye
{"title":"Adolescent vaccine introductions scoping review: A decade of insights from low- and middle-income countries (2013−2023)","authors":"Arman Majidulla ,&nbsp;Amelia K. Gerste ,&nbsp;Anurima Baidya ,&nbsp;Onimitein Georgewill ,&nbsp;Kirthini K. Muralidharan ,&nbsp;Degu J. Dare ,&nbsp;Joeri S. Buis ,&nbsp;Michelle M. Gill ,&nbsp;Julie A. Denison ,&nbsp;Andrew D. Kerkhoff ,&nbsp;Rupali J. Limaye","doi":"10.1016/j.jvacx.2025.100657","DOIUrl":"10.1016/j.jvacx.2025.100657","url":null,"abstract":"<div><h3>Background</h3><div>Adolescents benefit from vaccines before infection – such as HPV – but parental consent and frequent social interactions complicate their introductions. We conducted a scoping review of the literature (2013 to 2023) on adolescent vaccine introduction efforts in low- and middle-income countries to examine lessons learned.</div></div><div><h3>Method</h3><div>Following the PRISMA guideline, we searched four databases, screened abstracts and reviewed full text articles for inclusion. We included English full text articles which provided insights based on primary data collection into vaccine introductions for adolescents over the past ten years (i.e., 2013 onwards). We further searched the citations of included articles. We coded included articles for key characteristics and analyzed for thematic commonalities.</div></div><div><h3>Results</h3><div>Twenty-six studies met our inclusion criteria, and the findings clustered across three distinct phases of new vaccine introduction: planning, implementation/delivery, and post-implementation/delivery. During the planning phase, the early engagement of stakeholders – particularly ministries of health and education - was critical for coordination and readiness. During implementation, school-based delivery was the most common approach, often supplemented by community outreach and mop-up activities to reach out-of-school adolescents. Opt-out consent was used as a strategy in some contexts in keeping with existing adolescent vaccine protocols. Vaccine rumors and conspiracy needed to be actively managed in some contexts. Post-introduction, health systems impacts were generally minimal and temporary, although human resource constraints and cold-chain gaps emerged in some settings. Several countries reported positive spillover effects, such as strengthened collaboration between health and education sectors, expanded adolescent health promotion, and investments in vaccine infrastructure.</div></div><div><h3>Conclusion</h3><div>Adolescent vaccine introductions required multisectoral collaboration, flexible delivery models, and proactive community engagement. Future vaccine introductions would benefit from early stakeholder coordination and attention to context-specific delivery and consent strategies to ensure that vaccines are accepted, accessible, and equitably delivered.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100657"},"PeriodicalIF":2.7,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144178226","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
Safety, long-term effectiveness, and immunogenicity of varicella vaccination in children with juvenile idiopathic arthritis treated with biologic therapy 儿童特发性关节炎生物治疗水痘疫苗接种的安全性、长期有效性和免疫原性
IF 2.7
Vaccine: X Pub Date : 2025-05-20 DOI: 10.1016/j.jvacx.2025.100663
Maša Bizjak , Jakob Peterlin , Tadej Avčin , Miroslav Petrovec , Alojz Ihan , Mojca Zajc Avramovič , Gašper Markelj , Tina Vesel Tajnšek , Veronika Osterman , Jerneja Ahčan , Helena Mole , Katja Dejak Gornik , Alenka Biteznik , Sara Jevnikar , Larisa Janžič , Miha Bajc , Andreja Nataša Kopitar , Nataša Toplak
{"title":"Safety, long-term effectiveness, and immunogenicity of varicella vaccination in children with juvenile idiopathic arthritis treated with biologic therapy","authors":"Maša Bizjak ,&nbsp;Jakob Peterlin ,&nbsp;Tadej Avčin ,&nbsp;Miroslav Petrovec ,&nbsp;Alojz Ihan ,&nbsp;Mojca Zajc Avramovič ,&nbsp;Gašper Markelj ,&nbsp;Tina Vesel Tajnšek ,&nbsp;Veronika Osterman ,&nbsp;Jerneja Ahčan ,&nbsp;Helena Mole ,&nbsp;Katja Dejak Gornik ,&nbsp;Alenka Biteznik ,&nbsp;Sara Jevnikar ,&nbsp;Larisa Janžič ,&nbsp;Miha Bajc ,&nbsp;Andreja Nataša Kopitar ,&nbsp;Nataša Toplak","doi":"10.1016/j.jvacx.2025.100663","DOIUrl":"10.1016/j.jvacx.2025.100663","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate safety, long-term effectiveness and immunogenicity of varicella vaccination in children with JIA, treated with biologic disease-modifying antirheumatic drugs (bDMARDs).</div></div><div><h3>Methods</h3><div>This is a prospective case-control study. VZV-naive patients with JIA on selected bDMARDs (TNFi, IL-6 and IL-1 inhibitors), who were at risk for contracting varicella, had stable disease and normal values of immunoglobulins and lymphocyte populations, were vaccinated against varicella. Adverse events (AEs) and disease activity were followed after vaccination. VZV-specific humoral (VZV-IgG) and cell-mediated immunity (VZV-CMI) were measured at predetermined time points after vaccination by Liaison and intracellular cytokine staining, respectively. Two healthy control (HC) groups comprised 52 healthy children after varicella vaccination and 69 healthy children after varicella infection.</div></div><div><h3>Results</h3><div>17 patients were vaccinated against varicella (12 on TNFi, 4 on IL-6 inhibitors and 1 on IL-1 inhibitor), of whom 14 patients received both the first and second dose on bDMARDs. No vaccine-strain infections or other serious AEs occurred after vaccination. Disease activity increased in 3/17 (18 %) patients following vaccination. Four out of 17 (24 %) patients developed mild breakthrough varicella (BV) 4 months-4.5 years after vaccination, and none of the HC. Fourteen out of 17 (82 %) patients and 50/52 (96 %) vaccinated HC were seropositive after second vaccination and 8/11 (72 %) patients and 42/43 (98 %) vaccinated HC developed VZV-CMI, which persisted longer compared to VZV-IgG. Patients presented lower antibody levels compared to HC. The rate of VZV-IgG decline was comparable between patients and HC after vaccination or infection. Five patients received the third vaccine dose due to primary or secondary vaccine failure, and none of them developed BV.</div></div><div><h3>Conclusions</h3><div>Varicella vaccination was safe and largely immunogenic in our cohort of JIA patients treated with bDMARDs. Although the vaccination was not always fully effective, it prevented severe disease in all vaccinated patients.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"25 ","pages":"Article 100663"},"PeriodicalIF":2.7,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144147882","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
Modern approaches to predicting vaccine hesitancy: A scoping review 预测疫苗犹豫的现代方法:范围综述
IF 2.7
Vaccine: X Pub Date : 2025-05-17 DOI: 10.1016/j.jvacx.2025.100655
Keshav Gandhi , Sami Alahmadi , Rosie Hanneke , Alexander Gutfraind
{"title":"Modern approaches to predicting vaccine hesitancy: A scoping review","authors":"Keshav Gandhi ,&nbsp;Sami Alahmadi ,&nbsp;Rosie Hanneke ,&nbsp;Alexander Gutfraind","doi":"10.1016/j.jvacx.2025.100655","DOIUrl":"10.1016/j.jvacx.2025.100655","url":null,"abstract":"<div><h3>Introduction</h3><div>Motivated by the disproportionate burden of infectious diseases on vulnerable populations and the risk of future pandemics, we conducted a scoping review to analyze the state of the literature about “vaccine uptake indices,” defined as models that predict vaccination rates by geospatial area. We analyzed novel vaccine uptake indices created in response to the recent COVID-19 pandemic. The aim of this scoping review is to survey the state of the literature regarding vaccine uptake indices relating to COVID-19 and other infectious diseases.</div></div><div><h3>Methods</h3><div>We followed Arksey and O’Malley's scoping review framework and reported results according to PRISMA-ScR guidelines. Searches used controlled vocabulary and keywords across four conceptual domains: quantitative indices, geospatial analysis, infectious disease (COVID-19), and vaccination or vulnerability outcomes. Our systematic search strategy identifies relevant articles from the databases Embase, PubMed, and Web of Science with title and abstract screening, full-text review, and data extraction.</div></div><div><h3>Results</h3><div>Database searches resulted in 3615 potential articles, of which 229 reports were included. Fifteen studies (7 %) were determined to be methodologically advanced vaccine uptake indices that had at least three of the following characteristics: the use of individual- and population-level predictor variables (100 [44 %]), geo-spatiotemporal analysis (58 [25 %]), data usage agnostic to vaccine specificity (50 [22 %]), or sociobehavioral frameworks of health (such as the Health Belief Model and Theory of Planned Behavior) (30 [13 %]).</div></div><div><h3>Conclusion</h3><div>This scoping review offers suggestions for future research of next-generation vaccine uptake indices before use in vaccination campaigns of recurring or novel infectious diseases. Areas to pursue include utilizing individual-level data about vaccination behaviors in conjunction with administrative data, solving the challenge of implementing small-area spatiotemporal analysis, using vaccine-agnostic methods that consider data from more than one infectious disease, and assisting causal inference with theoretical frameworks.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100655"},"PeriodicalIF":2.7,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144116879","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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