Yuan Yemin, Wang Tong, Xia Yiqi, Shi Zhenyu, He Ping
School of Public Health, Peking University, Beijing, 100191, China.
China Center for Health Development Studies, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.
BMC Infect Dis. 2025 Jul 5;25(1):897. doi: 10.1186/s12879-025-11275-w.
This study aimed to synthesize existing evidence to compare the immunogenicity and safety of domestic and imported live-attenuated varicella vaccine (VarV) in healthy Chinese populations.
We searched PubMed, Web of Science, Embase, China National Knowledge Internet (CNKI), Wan Fang Database, and Chinese Biomedical Literature Service System (SinoMed) using predefined search terms to identify relevant studies. Retrieve all language articles up to March 15, 2024. Articles reported varicella vaccination in healthy Chinese populations were included. We calculated the pooled rates of seroconversions and adverse events using the random effects model and assessed the quality of each study using the modified Jadad Scale and Newcastle Ottawa Scale (NOS). Publication bias was evaluated using Egger's regression test.
In our immunogenicity analysis, which included 16,655 Chinese individuals from 21 studies, the pooled seroconversion rate was 89% (95%CI: 86-91%) for domestic VarV and 93% (95%CI: 88-98%) for imported Varv, with no statistically significant difference. In our safety analysis, which included 29,696 Chinese individuals from 25 studies, the pooled rate of systemic reactions was higher for domestic Varv (11%, 95%CI: 10-13%) than for imported Varv (8%, 95%CI: 6-10%; P < 0.001), while the results for local reactions were the opposite (domestic Varv: 3%, 95%CI: 2-3%; imported Varv: 7%, 95%CI: 3-10%; P = 0.020). The results are based on pooled proportions rather than direct comparison. Egger's test suggested that publication bias was not negligible.
Both domestic and imported varicella vaccines appear to be generally immunogenic and safe in healthy Chinese populations. However, due to limited and heterogeneous data on imported vaccines, further high-quality studies are needed to validate these comparative findings.
本研究旨在综合现有证据，比较国产和进口减毒活水痘疫苗（VarV）在健康中国人群中的免疫原性和安全性。
我们使用预定义的检索词在PubMed、Web of Science、Embase、中国知网（CNKI）、万方数据库和中国生物医学文献服务系统（SinoMed）中进行检索，以识别相关研究。检索截至2024年3月15日的所有语言文章。纳入报道健康中国人群水痘疫苗接种情况的文章。我们使用随机效应模型计算血清转化率和不良事件的合并率，并使用改良的Jadad量表和纽卡斯尔渥太华量表（NOS）评估每项研究的质量。使用Egger回归检验评估发表偏倚。
在我们的免疫原性分析中，纳入了来自21项研究的16,655名中国个体，国产VarV的合并血清转化率为89%（95%CI：86 - 91%），进口Varv为93%（95%CI：88 - 98%），差异无统计学意义。在我们的安全性分析中，纳入了来自25项研究的29,696名中国个体，国产Varv的全身反应合并率（11%，95%CI：10 - 13%）高于进口Varv（8%，95%CI：6 - 10%；P < 0.001），而局部反应结果相反（国产Varv：3%，95%CI：2 - 3%；进口Varv：7%，95%CI：3 - 10%；P = 0.020）。结果基于合并比例而非直接比较。Egger检验表明发表偏倚不可忽视。
国产和进口水痘疫苗在健康中国人群中似乎都具有普遍的免疫原性和安全性。然而，由于进口疫苗的数据有限且存在异质性，需要进一步的高质量研究来验证这些比较结果。
