Jotautis Vaidas, Sarantaki Antigoni
Kauno Kolegija Higher Education, Faculty of Medicine, Pramones pr 20, 50468 Kaunas, Lithuania.
Midwifery Department, Faculty of Health and Care Sciences, University of West Attica, Ag. Spyridonos, Egaleo, 12243 Athens, Greece.
Vaccines (Basel). 2025 Jan 9;13(1):53. doi: 10.3390/vaccines13010053.
Hepatitis E virus (HEV) infection presents a significant health risk in endemic regions, especially for pregnant women, who face higher risks of severe complications, including maternal and fetal mortality. The recombinant HEV vaccine, HEV239, has demonstrated high efficacy in the general population, yet data on its safety and efficacy in women of a childbearing age remain limited. This systematic review and meta-analysis aim to evaluate the safety and effectiveness of HEV239 in this specific population, with a focus on pregnancy-related outcomes.
A comprehensive search was conducted in PubMed, Embase, Cochrane Library, and Scopus, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were included if they reported outcomes on HEV239's safety or efficacy in women of childbearing age, with data being extracted and analyzed for immunogenicity, HEV incidence, and maternal adverse events. The risk of bias was assessed using the Cochrane and Newcastle Ottawa Scales, and a random-effects meta-analysis was performed.
Three studies, enrolling over 23,000 participants, were included in the current systematic review, with two meeting the criteria for meta-analysis. HEV239 demonstrated high efficacy in preventing hepatitis E infection, with no significant increase in adverse pregnancy outcomes such as stillbirth or elective termination. However, there was an elevated risk of miscarriage (odds ratio [OR], 1.60; 95% confidence interval [CI], 0.99-2.57). The analysis revealed high heterogeneity for miscarriage outcomes (I = 67%), reflecting variability in study designs and populations.
HEV239 is effective in preventing HEV infection among women of childbearing age, although caution is advised when administering the vaccine near conception due to potential miscarriage risks. Future studies should focus on understanding the biological mechanisms and timing-specific safety to guide vaccination recommendations.
戊型肝炎病毒（HEV）感染在流行地区构成重大健康风险，尤其是对孕妇而言，她们面临包括母婴死亡在内的严重并发症的更高风险。重组HEV疫苗HEV239在普通人群中已显示出高效性，但关于其在育龄妇女中的安全性和有效性的数据仍然有限。本系统评价和荟萃分析旨在评估HEV239在这一特定人群中的安全性和有效性，重点关注与妊娠相关的结局。
按照系统评价和荟萃分析的首选报告项目（PRISMA）指南，在PubMed、Embase、Cochrane图书馆和Scopus中进行了全面检索。纳入报告HEV239在育龄妇女中的安全性或有效性结局的研究，并提取和分析免疫原性、HEV发病率和孕产妇不良事件的数据。使用Cochrane和纽卡斯尔渥太华量表评估偏倚风险，并进行随机效应荟萃分析。
本系统评价纳入了三项研究，共23000多名参与者，其中两项符合荟萃分析标准。HEV239在预防戊型肝炎感染方面显示出高效性，死产或选择性终止妊娠等不良妊娠结局没有显著增加。然而，流产风险有所升高（优势比[OR]，1.60；95%置信区间[CI]，0.99 - 2.57）。分析显示流产结局存在高度异质性（I² = 67%），反映出研究设计和人群的差异。
HEV239在预防育龄妇女的HEV感染方面是有效的，尽管由于存在潜在的流产风险，在接近受孕时接种疫苗时应谨慎。未来的研究应侧重于了解生物学机制和特定时间的安全性，以指导疫苗接种建议。
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