Shi Qianqian, Li Jun, Hu Quanman, Cheng Cheng, Yang Kun, Li Xiaoyu, Song Xiaoru, Chen Shuaiyin, Duan Guangcai
Department of Epidemiology and Statistics, College of Public Health, Zhengzhou University, Zhengzhou 450001, China.
Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.
Vaccines (Basel). 2025 Jun 20;13(7):666. doi: 10.3390/vaccines13070666.
A growing number of countries implement prenatal pertussis vaccination policies to safeguard unvaccinated infants. This meta-analysis aimed to evaluate the efficacy, immunogenicity, and safety of antenatal Tdap vaccination in pregnant individuals.
We systematically searched PubMed, Embase, and Web of Science from their inception to 16 February 2025, rigorously screening studies and including seven randomized controlled trials and 10 case-control studies published between 2014 and 2024. For the test-negative design meta-analysis, odds ratios with 95% confidence intervals served as effect estimates, and vaccine efficacy was calculated accordingly. Standardized mean differences were used to assess geometric mean concentrations, while relative risks evaluated safety.
Maternal vaccination during pregnancy demonstrated 85% vaccine effectiveness (95% CI: 78-89%) in protecting infants under 3 months old. Pooled standardized mean differences for cord blood IgG antibodies against pertussis toxin, pertactin, and filamentous hemagglutinin were 1.57 (95% CI: 1.25-1.89), 2.15 (95% CI: 1.82-2.48), and 2.25 (95% CI: 1.81-2.68), respectively, indicating higher antibody levels in infants of vaccinated women before their first immunization. Safety analysis showed no significant association between Tdap vaccination during pregnancy and serious adverse events in infants (RR = 0.76, 95% CI: 0.46-1.24) and pregnant women (RR = 1.22, 95% CI: 0.83-1.81).
Our findings support the implementation of pertussis vaccination during pregnancy.
越来越多的国家实施产前百日咳疫苗接种政策，以保护未接种疫苗的婴儿。本荟萃分析旨在评估孕妇接种破伤风类毒素、白喉类毒素和无细胞百日咳疫苗（Tdap）的有效性、免疫原性和安全性。
我们系统检索了PubMed、Embase和Web of Science数据库，检索时间从建库至2025年2月16日，严格筛选研究，纳入了2014年至2024年发表的7项随机对照试验和10项病例对照研究。对于检验阴性设计的荟萃分析，以95%置信区间的比值比作为效应估计值，并据此计算疫苗效力。标准化均值差用于评估几何平均浓度，相对风险用于评估安全性。
孕期母亲接种疫苗在保护3个月以下婴儿方面显示出85%的疫苗效力（95%置信区间：78 - 89%）。针对百日咳毒素、百日咳杆菌黏附素和丝状血凝素的脐血IgG抗体的合并标准化均值差分别为1.57（95%置信区间：1.25 - 1.89）、2.15（95%置信区间：1.82 - 2.48）和2.25（95%置信区间：1.81 - 2.68），表明接种疫苗的女性所生婴儿在首次免疫前抗体水平更高。安全性分析显示，孕期接种Tdap疫苗与婴儿严重不良事件（相对风险 = 0.76，95%置信区间：0.46 - 1.24）和孕妇严重不良事件（相对风险 = 1.22，95%置信区间：0.83 - 1.81）之间无显著关联。
我们的研究结果支持在孕期实施百日咳疫苗接种。
