Expert Review of Vaccines最新文献

Economic analysis of 15-valent and 20-valent pneumococcal conjugate vaccines among older adults in Ontario, Canada. 加拿大安大略省老年人中15价和20价肺炎球菌结合疫苗的经济分析

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-04-07 DOI: 10.1080/14760584.2025.2488495

Gebremedhin B Gebretekle, Ryan O'Reilly, Stephen Mac, Shaza Fadel, Natasha S Crowcroft, Beate Sander

{"title":"Economic analysis of 15-valent and 20-valent pneumococcal conjugate vaccines among older adults in Ontario, Canada.","authors":"Gebremedhin B Gebretekle, Ryan O'Reilly, Stephen Mac, Shaza Fadel, Natasha S Crowcroft, Beate Sander","doi":"10.1080/14760584.2025.2488495","DOIUrl":"10.1080/14760584.2025.2488495","url":null,"abstract":"Background: Health Canada approved two new pneumococcal conjugate vaccines (PCV), 15-valent (PCV15) and 20-valent (PCV20), and we assessed their cost-effectiveness for older Ontarians.Research design and methods: We conducted a cost-utility analysis using an individual-level state transition model to compare one dose of PCV (alone or in series with PPV23) with PPV23-only. We estimated incremental cost-effectiveness ratios (ICERs) expressed in costs (C$2022) per quality-adjusted life year (QALY) from the healthcare payer perspective, discounted at 1.5% annually.Results: A sequential comparison of vaccinations with no indirect effect from childhood vaccination resulted in an ICER of $44,324/QALY for PCV15-alone compared to PPV23-only, and $70,751/QALY for PCV20-alone versus PCV15-alone. None of the PCV15/20 combined with PPV23 programs were cost-effective at a C$50,000/QALY threshold. PCV20 alone had an ICER of C$46,961/QALY compared to PPV23-only. When considering indirect effects, PCV15/20 alone or in series with PPV23 were not cost-effective. ICERs were mostly influenced by vaccine characteristics (effectiveness, waning, cost) and the incidence of pneumococcal community-acquired pneumonia.Conclusions: Vaccinating older adults with PCV15/20 likely reduces burden of pneumococcal disease and would be cost-effective initially, but is expected to be less economically attractive in the longer term when herd immunity benefits from childhood vaccination programs are considered.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"1-10"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771916","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}

引用次数: 0

Typhoid conjugate vaccines: is a single dose enough for durable protection? 伤寒结合疫苗：单剂量是否足以提供持久保护？

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-03-11 DOI: 10.1080/14760584.2025.2476525

Vipin M Vashishtha, Puneet Kumar

{"title":"Typhoid conjugate vaccines: is a single dose enough for durable protection?","authors":"Vipin M Vashishtha, Puneet Kumar","doi":"10.1080/14760584.2025.2476525","DOIUrl":"10.1080/14760584.2025.2476525","url":null,"abstract":"Introduction: Typhoid fever is widespread in developing countries. Most typhoid vaccines have gone into some disrepute for their substantial side effects and low efficacy. The latest typhoid vaccines use Salmonella's Vi-capsular polysaccharide (Vi-CPS) conjugated to a protein carrier. The WHO recommends a single typhoid conjugate vaccine (TCV) dose at six months in endemic countries. However, this schedule is contested.Areas covered: The molecular structure of Vi-CPS, emerging Vi capsule variants, the impact of de-O acetylation on vaccine immunogenicity, the key features of an effective Vi-PS conjugate vaccine, the immunological correlates of protection, the impact of boosting by a TCV on Vi-antibodies, and knowledge gaps were examined. We have also reviewed TCV efficacy and durability data. Our analysis shows that the vaccines are effective, although immunity wanes after five years, especially in children under two. We also offered ways to improve TCV efficacy and briefly discussed new typhoid vaccine development.Expert opinion: We believe the TCV schedule necessitates revision. Extending the primary immunization age or incorporating a booster upon school enrollment are reasonable alternatives. Region-specific or universal modifications require further deliberation.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"194-205"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566543","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}

引用次数: 0

The protective effects of two varicella vaccination strategies: A Bayesian modeling study in two megacities in South China. 两种水痘疫苗接种策略的保护作用：中国南方两个特大城市的贝叶斯模型研究

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-03-17 DOI: 10.1080/14760584.2025.2476524

Xing Huang, Jialing Li, Yihan Li, Weilin Zeng, Qi Zhu, Jun Liu, Pei Hu, Zhihua Zhu, Zhongyi Fan, Ying Yang, Siqing Zeng, Zhihao Li, Jianpeng Xiao, Limei Sun, Jianfeng He

{"title":"The protective effects of two varicella vaccination strategies: A Bayesian modeling study in two megacities in South China.","authors":"Xing Huang, Jialing Li, Yihan Li, Weilin Zeng, Qi Zhu, Jun Liu, Pei Hu, Zhihua Zhu, Zhongyi Fan, Ying Yang, Siqing Zeng, Zhihao Li, Jianpeng Xiao, Limei Sun, Jianfeng He","doi":"10.1080/14760584.2025.2476524","DOIUrl":"10.1080/14760584.2025.2476524","url":null,"abstract":"Background: China implemented diverse varicella vaccination strategies from 2012 to 2022, with unclear protective effects. The study aimed to evaluate the effects of two varicella vaccination (VarV) (the two-dose self-paid VarV and the two-dose free VarV) strategies implemented in Guangdong Province, China.Research design and methods: We collected data on varicella cases and doses administered to children aged 0-14 in Guangzhou, Shenzhen, and Foshan from 2012 to 2022. Using Bayesian Structured Time Series (BSTS) model, we estimated the effects of the two VarV strategies in Guangzhou and Shenzhen starting from 2018, by referencing Foshan.Results: Post-implementation of the two-dose self-paid VarV strategy 36,749 (95% CI: 29070, 44428) and 24,179 (95% CI: 16400, 31958) varicella cases were averted in Guangzhou and Shenzhen, with a protection rate of 41.8% (95% CI: 36.3%, 46.5%) and 38.9% (95% CI: 30.2%, 45.7%), respectively. After the adoption of the two-dose free VarV strategy, a substantial relative protection rate of 64.2% (95% CI: 58.0%, 68.7%) in varicella cases was observed in Shenzhen, with 38,828 (95% CI: 29979, 47677) cases averted by 2022.Conclusions: The two-dose VarV strategies have proven highly effective in reducing varicella incidence. The experience in Shenzhen underscores the benefits of a two-dose free VarV strategy.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"212-220"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585458","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}

引用次数: 0

Potential public health and economic impact of maternal vaccination with bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine for the prevention of acute respiratory infection among infants in the United States. 美国母亲接种二价呼吸道合胞病毒预融合F （RSVpreF）疫苗预防婴儿急性呼吸道感染的潜在公共卫生和经济影响

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-05-22 DOI: 10.1080/14760584.2025.2503966

Ahuva Averin, Amy W Law, Derek Weycker, Mark Atwood, Erin Quinn, Jessica E Atwell, Alejandro Cane, Bradford D Gessner, Sarah Pugh, Kimberly M Shea

{"title":"Potential public health and economic impact of maternal vaccination with bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine for the prevention of acute respiratory infection among infants in the United States.","authors":"Ahuva Averin, Amy W Law, Derek Weycker, Mark Atwood, Erin Quinn, Jessica E Atwell, Alejandro Cane, Bradford D Gessner, Sarah Pugh, Kimberly M Shea","doi":"10.1080/14760584.2025.2503966","DOIUrl":"10.1080/14760584.2025.2503966","url":null,"abstract":"Background: The U.S. Advisory Committee on Immunization Practices recommends use of bivalent stabilized prefusion F subunit vaccine (RSVpreF) among pregnant persons to protect their infants against lower respiratory tract illness due to RSV (RSV-LRTI).Research design and methods: Using a cohort model depicting clinical outcomes and economic costs of RSV acute respiratory infection (RSV-ARI) among US infants from birth to age 1 year, we evaluated the impact of seasonally administered maternal RSVpreF versus no intervention. Outcomes included cases of medically attended RSV-ARI, RSV-related deaths, medical costs, and indirect costs. Costs were reported in 2023 US$.Results: Among the 3.7 million US infants aged <12 months each year, a total of 1,148,967 RSV-ARI cases (hospital: 48,384; emergency department [ED]: 246,118; outpatient clinic [OC]: 854,465) were projected to occur, yielding total annual costs of $2.4 billion (direct: $1.7B; indirect: $0.7B). With 54.9% uptake, RSVpreF would prevent 89,908 cases (hospital: 10,308; ED: 20,538; OC: 59,062), corresponding with a $368 million decrease (direct: $286 M; indirect: $81 M) in total 1-year costs.Conclusion: Even with limited uptake and without considering benefits to pregnant persons or reductions in RSV-related sequelae, maternal vaccination with RSVpreF would substantially reduce the public health and economic burden of RSV-ARI in US infants.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"403-411"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144005205","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}

引用次数: 0

Controlling the COVID-19 pandemic through vaccination: a perspective from Indonesia. 通过疫苗接种控制COVID-19大流行：来自印度尼西亚的视角。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-01-15 DOI: 10.1080/14760584.2025.2451883

Rano K Sinuraya, Auliya A Suwantika, Maarten J Postma

引用次数: 0

Strategies to increase influenza vaccination coverage in the Italian pediatric population: a literature review and expert opinion. 提高意大利儿童流感疫苗接种覆盖率的策略：文献综述和专家意见。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-04-07 DOI: 10.1080/14760584.2025.2487915

Paolo Bonanni, Michele Conversano, Giancarlo Icardi, Rocco Russo, Alberto Villani

{"title":"Strategies to increase influenza vaccination coverage in the Italian pediatric population: a literature review and expert opinion.","authors":"Paolo Bonanni, Michele Conversano, Giancarlo Icardi, Rocco Russo, Alberto Villani","doi":"10.1080/14760584.2025.2487915","DOIUrl":"10.1080/14760584.2025.2487915","url":null,"abstract":"Introduction: Vaccination rates in Italian children must be substantially increased to control the transmission of seasonal influenza and mitigate the associated socio-economic burden. This work aimed to describe strategies to improve the effectiveness and reach of pediatric influenza vaccination campaigns in Italy.Areas covered: Based on a literature review, influencing factors and potential strategies to enhance vaccination coverage were explored, focusing on settings, logistics, and communication aspects.Expert opinion: School-based interventions should be deeply implemented in Italy by offering a cost-effective and safe approach to vaccination and successfully overcoming socio-economic and cultural challenges. Scheduled educational programs and institution-supported childhood influenza vaccination awareness campaigns that thoroughly inform about the risk of influenza and its socio-economic consequences, counter vaccine hesitancy, and discuss the benefits of vaccination are desirable, thus concretely prompting all children, families, and healthcare professionals to get vaccinated. Digitalizing procedures could lead to improved adherence by healthcare professionals to immunization programs. Nationwide implementation of these strategies would establish a robust, sustainable system for pediatric influenza vaccination. This would significantly increase childhood vaccination rates, leading to improved disease control and substantially reducing the overall national burden of influenza.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"24 1","pages":"278-288"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794376","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}

引用次数: 0

Modeling the potential public health and economic impact and cost-effectiveness of vaccination strategies using an adapted COVID-19 vaccine in Mexico. 在墨西哥对使用适应性COVID-19疫苗的疫苗接种策略的潜在公共卫生和经济影响以及成本效益进行建模。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-05-15 DOI: 10.1080/14760584.2025.2505087

Carlos Fernando Mendoza, Jose Luis Huerta, Iustina Chirila, Dania Abreu, Moe H Kyaw, Benjamin Yarnoff

{"title":"Modeling the potential public health and economic impact and cost-effectiveness of vaccination strategies using an adapted COVID-19 vaccine in Mexico.","authors":"Carlos Fernando Mendoza, Jose Luis Huerta, Iustina Chirila, Dania Abreu, Moe H Kyaw, Benjamin Yarnoff","doi":"10.1080/14760584.2025.2505087","DOIUrl":"10.1080/14760584.2025.2505087","url":null,"abstract":"Background: This study evaluated the impact of vaccination strategies using an adapted COVID-19 vaccine in Mexico.Research design and methods: This study used a previously published combined Markov-decision tree model adapted for the Mexican context. The base case examined the population aged ≥ 65 years and the high-risk population (defined as those with one or more comorbidities associated with high risk of severe disease) aged 12-64 years. Scenario analyses examined lower age cutoffs for eligibility in the standard risk population (≥50 years, ≥18 years, and ≥12 years). Sensitivity analyses varying the parameters by ± 20% was conducted to assess uncertainty.Results: Compared to no vaccination, the base case was estimated to prevent 1,509,194 cases, 132,166 hospitalizations 24,575 deaths, and 276,223 lost quality-adjusted life-years (QALYs), increasing direct costs by $602,446,820 and decreasing societal cost by $2,264,266,271. The ICER was dominant from the societal perspective and $2,181 from the payer perspective, which was cost-effective at a willingness-to-pay threshold of 1× GDP per capita ($11,812). The benefits were further increased in scenarios expanding vaccination to additional age groups.Conclusions: Vaccination strategies targeting a broader age range with an adapted vaccine would result in considerable health and economic benefits and be cost-effective in Mexico.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"393-402"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144063036","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}

引用次数: 0

Dilemma in prevention of pertussis infection among infants under six months in China. 中国6个月以下婴儿预防百日咳感染的困境。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-01-28 DOI: 10.1080/14760584.2025.2459745

Xiang Sun

{"title":"Dilemma in prevention of pertussis infection among infants under six months in China.","authors":"Xiang Sun","doi":"10.1080/14760584.2025.2459745","DOIUrl":"10.1080/14760584.2025.2459745","url":null,"abstract":"Introduction: Pertussis poses a significant threat to infants under six months due to their immature immune systems, limited maternal antibody protection, and constraints in the vaccination schedule. Despite vaccination efforts, this group remains highly susceptible to severe complications. Addressing these challenges is crucial for improving the health outcomes of infants in China.Areas covered: This review examines the primary challenges in preventing pertussis infections among infants under six months in China, focusing on factors such as underdeveloped immune system and inadequate maternal antibody protection. It analyzes limitations in current vaccination strategies and the impact of socio-cultural factors, healthcare resource distribution, and surveillance inadequacies. A comprehensive literature search was conducted to identify potential solutions, including enhancing maternal immunization, adjusting early vaccination strategies, increasing vaccine coverage, and developing new vaccines. The review synthesizes current research findings and data to provide a detailed overview of these issues.Expert opinion: Infants under six months are particularly vulnerable to pertussis. Early and effective prevention strategies, such as enhanced maternal immunization and adjusted vaccination schedules, are needed. Increasing vaccine coverage and developing safer, more immunogenic vaccines are essential. Policymakers should prioritize these measures to reduce pertussis incidence and complications among infants in China.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"138-145"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046160","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}

引用次数: 0

Readiness assessment for cervical cancer elimination and prevention of human papillomavirus (HPV)-related cancers in Europe - are we winning the RACE? 欧洲消除宫颈癌和预防人乳头瘤病毒（hpv）相关癌症的准备情况评估——我们是否赢得了竞赛？

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2024-12-15 DOI: 10.1080/14760584.2024.2438759

Eugenia Karamousouli, Ugne Sabale, Stefano Valente, Fanut Morosan, Maria Heuser, Olivia Dodd, Danielle Riley, Louise Heron, Giovanna Elisa Calabrò, Theodoros Agorastos, Paul Sevelda, Zoárd Tibor Krasznai, Shay Nahum, Rune Horby

{"title":"Readiness assessment for cervical cancer elimination and prevention of human papillomavirus (HPV)-related cancers in Europe - are we winning the RACE?","authors":"Eugenia Karamousouli, Ugne Sabale, Stefano Valente, Fanut Morosan, Maria Heuser, Olivia Dodd, Danielle Riley, Louise Heron, Giovanna Elisa Calabrò, Theodoros Agorastos, Paul Sevelda, Zoárd Tibor Krasznai, Shay Nahum, Rune Horby","doi":"10.1080/14760584.2024.2438759","DOIUrl":"10.1080/14760584.2024.2438759","url":null,"abstract":"Introduction: To address the cervical cancer burden globally, the World Health Organization and European Union released strategies to facilitate HPV-related cancers prevention, including cervical cancer elimination. This research assessed European country level readiness to achieve cervical cancer elimination by adhering to such strategies.Areas covered: Readiness for cervical cancer elimination was assessed across a range of guiding questions relevant to three defined key domains: vaccination, screening, and treatment, each with two sub-domains focusing on decision making and implementation efforts. Publicly available data sources were used to inform the scoring across domains, to tier countries into either high, moderate-high, moderate-low, and low readiness archetypes.Key parameters identified associated with the high readiness archetype were high vaccination coverage rates (>70%), availability of gender neutral and catch-up vaccination, school-based vaccination availability, organized screening programs, use of HPV DNA primary screening tests, and data surveillance.Expert opinion: Our analysis highlights significant variability in decision making and implementation of vaccination, screening, and treatment programmes across Europe. Country scores expose the need for a multifaceted approach to achieve cervical cancer elimination in Europe, encompassing solid decision making commitments, implementation of these commitments, and the ability to collect, surveil, and apply the data use accurately.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"11-26"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817315","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}

引用次数: 0

Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants. 二价蛋白COVID-19疫苗SCTV01C对抗原匹配和不匹配变体的持续免疫原性

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2025-12-01 Epub Date: 2025-01-27 DOI: 10.1080/14760584.2025.2456231

Guiqiang Wang, Kexin Zhao, Xiuli Zhao, Yimin Cui, Peng He, Tianzuo Zhang, Yanchao Wang, Rui Shi, Yanhua Li, Qian Wang, Yanping Ren, Zhisong Chen, Xuedan Zhao, Zekang Xie, Yufei Liang, Qingyun Tian, Jing Pan, Chao Zhang, Ying Han, Yuyang Dai, Siyang Ni, Yun Zhang, Xinjie Yang, Yongpan Fu, Dongfang Liu, Jing Li, Miaomiao Zhang, Zhongyu Hu, Liangzhi Xie

{"title":"Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants.","authors":"Guiqiang Wang, Kexin Zhao, Xiuli Zhao, Yimin Cui, Peng He, Tianzuo Zhang, Yanchao Wang, Rui Shi, Yanhua Li, Qian Wang, Yanping Ren, Zhisong Chen, Xuedan Zhao, Zekang Xie, Yufei Liang, Qingyun Tian, Jing Pan, Chao Zhang, Ying Han, Yuyang Dai, Siyang Ni, Yun Zhang, Xinjie Yang, Yongpan Fu, Dongfang Liu, Jing Li, Miaomiao Zhang, Zhongyu Hu, Liangzhi Xie","doi":"10.1080/14760584.2025.2456231","DOIUrl":"10.1080/14760584.2025.2456231","url":null,"abstract":"Background: The development of bivalent or multivalent vaccines offers a promising strategy for combating SARS-CoV-2 mutations.Research design and methods: In this phase 2 trial, conducted from 1 December 2021, to 25 July 2023, 392 unvaccinated adults aged ≥18 years were randomized to receive a primary series of two doses and a booster dose of SCTV01C, a bivalent protein SARS-CoV-2 vaccine.Results: Geometric mean titers (GMTs) of neutralizing antibodies (nAb) against live Alpha, Beta, Delta, and Omicron showed 85.4-, 100.0-, 32.1-, and 9.8-fold increase from baseline on 28 days, and 49.4-, 55.3-, 5.7-fold increase against live Alpha, Beta, and Omicron on 90 days after primary series. At Day 28 and Day 90 following the booster dose, GMTs of nAb against Beta, BA.2 and BA.5 variants showed 12.1- and 8.8-, 13.8- and 7.1-, 18.7-, and 11.9-fold of increase from baseline, respectively. Reactogenicity was generally mild, with one adverse event of special interest (AESI) and 9 ≥Grade 3 treatment-related adverse events (TRAEs); all recovered within 3 days.Conclusions: SCTV01C, when administered as both a primary series and a booster vaccination, exhibited encouraging sustained immunogenicity against both antigen-matched and antigen-mismatched variants, with no significant safety concerns.Clinical trial registration: www.clinicaltrials.gov identifier is NCT05148091.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"128-137"},"PeriodicalIF":5.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002957","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}

引用次数: 0