免疫反应和怀孕期间无活化SARS-CoV-2疫苗的安全性:现实世界的观察性研究
Yajie Gong1,2,3, Xi Zhang1,2,3, Xue Han1,2,3
1School of Public Health, Guangdong Pharmaceutical University, Guangzhou, China.
Expert review of vaccines
|October 19, 2023
概括
失活的SARS-CoV-2疫苗在孕妇中显示出有利的免疫持久性. 抗体水平随着时间的推移而降低,但与怀孕前接种疫苗相比,不良事件没有增加.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 孕产妇健康 孕产妇健康
背景情况:
- 孕妇经常被排除在疫苗临床试验之外.
- 在接受SARS-CoV-2疫苗的孕妇中评估免疫反应至关重要.
研究的目的:
- 评估在孕妇中无活化SARS-CoV-2疫苗的免疫反应和安全性.
- 确定在怀孕期间接种疫苗后与抗体阳性相关的因素.
主要方法:
- 一项多中心的横截面研究,对873名18-45岁的孕妇进行了研究.
- 测量血清抗体水平和收集自我报告的不良事件.
- 用物流回归和受限制的立方线模型来分析数据.
主要成果:
- 中和抗体 (NAb) 阳性率高 (98.3%) 在三剂后,随着剂量减少和时间的推移而下降.
- 疫苗剂量和接种疫苗后的时间与NAb阳性有显著的关联 (P <0.05).
- 不良事件是轻度/中度,与怀孕前接种疫苗相比,不增加发病率.
结论:
- 失活的疫苗诱导了孕妇的有利免疫持久性.
- 在怀孕期间接种疫苗并没有增加不良事件的发生率.
- 该研究强调了在孕妇人群中评估疫苗有效性和安全性的重要性.
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