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流行性乙型脑炎疫苗基础免疫有效性、持久性及安全性meta分析

Immunogenicity, antibody persistence, and safety of Japanese encephalitis vaccines in primary immunization: a meta-analysis

    摘要
  • 摘要:
    目的 评价中国现行免疫规划中使用的流行性乙型脑炎（简称“乙脑”）减毒活疫苗和灭活疫苗（Vero细胞）基础免疫后的有效性、持久性及安全性，为优化我国乙脑疫苗的免疫策略提供参考依据。
    方法 检索中国知网数据库、万方数据知识服务平台、PubMed数据库、Cochrane数据库和 Web of Science 数据库，收集2000年1月1日—2025年2月28日国内外公开发表的有关乙脑疫苗安全性和有效性的随机对照试验文献，应用RevMan 5.3 和 R 4.4.1 软件对纳入的文献进行单组率meta分析。
    结果 最终纳入20篇相关文献（中文文献9篇、英文文献11篇），包括27个疫苗队列人群，累计研究对象5 445人。Meta分析结果显示，乙脑疫苗基础免疫后28～30 d合并血清阳转率为91.12%（95%CI=84.75%～94.99%），基础免疫后1年合并抗体阳性率为86.32%（95%CI=62.75%～95.94%），基础免疫后总不良反应合并发生率为24.10%（95%CI=14.59%～37.11%）;严重不良反应合并发生率为0.19%（95%CI=0～0.91%）。亚组分析结果显示，不同地区和年龄人群乙脑疫苗基础免疫后血清阳转率差异均有统计学意义（均P<0.01）。不同类型乙脑疫苗基础免疫后血清阳转率、抗体阳性率、总不良反应发生率和严重不良反应发生率差异均无统计学意义（均P>0.05），不同地区和年龄人群乙脑疫苗基础免疫后抗体阳性率、总不良反应发生率和严重不良反应发生率差异均无统计学意义（均P>0.05）。通过文献剔除法进行敏感性分析，结果显示，剔除较小样本的研究后，本次meta分析结果较为稳定。
    结论 中国现行使用的乙脑疫苗基础免疫后表现出良好的免疫原性、持续的免疫保护及可接受的安全性，其免疫应答受接种地区和受种者年龄的显著影响。

     

    Abstract:
    Objective To evaluate the effectiveness, antibody persistence, and safety of Japanese encephalitis (JE) attenuated live vaccines and inactivated (Vero cell) vaccines currently used in China's national immunization program following primary immunization, thus providing evidence for optimizing JE vaccination strategies in China.
    Methods We systematically searched CNKI, Wanfang Data, PubMed, Cochrane Library, and Web of Science for randomized controlled trials (RCTs) on the safety and effectiveness of JE vaccines that were published from January 1, 2000 to February 28, 2025. RevMan 5.3 and R 4.4.1 were used for single-arm proportion meta-analyses.
    Results A total of 20 eligible articles (9 in Chinese, 11 in English) were included, comprising 27 vaccine cohorts with 5 445 participants. Meta-analysis results showed that the pooled seroconversion rate (SCR) 28–30 days after primary immunization was 91.12% (95%CI: 84.75%–94.99%). The pooled antibody persistence rate 1 year after primary immunization was 86.32% (95%CI: 62.75%–95.94%). The pooled incidence of total adverse events (AEs) was 24.10% (95%CI: 14.59%–37.11%), and the pooled incidence of serious adverse events (SAEs) was 0.19% (95%CI: 0.00%–0.91%). Subgroup analyses revealed differences in SCR across different geographical regions and age groups (all P < 0.01). However, no significant differences were found in SCR, antibody persistence rate, total incidence of AEs, or incidence of SAEs between different vaccine types (all P > 0.05). Similarly, no significant differences were observed across regions or age groups for antibody persistence rate, total incidence of AEs, or incidence of SAEs (all P > 0.05). Sensitivity analysis using the study removal method showed that the meta-analysis results remained stable after excluding smaller studies.
    Conclusions The JE vaccines currently used in China demonstrate great immunogenicity, sustained immune protection, and acceptable safety after primary immunization. It is recommended that regional and population differences be considered in immunization strategy planning, and immunization protection and post-vaccination monitoring be strengthened for key populations such as children.

     

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