Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial

作者：Guo‐Hua Zhong, Chunlan Zhuang, Xiaowen Hu, Qi Chen, Zhaofeng Bi, Xinhua Jia, Siying Peng, Yufei Li, Yue Huang, Qiufen Zhang, Ying Hong, You‐Lin Qiao, Yingying Su, Huirong Pan, Ting Wu, Lihui Wei, Shoujie Huang, Jun Zhang, Ningshao Xia · 发表于：Emerging Microbes & Infections · 年份：2023 · DOI：10.1080/22221751.2023.2185456 · 被引用次数：25 · 研究领域：Hepatitis Viruses Studies and Epidemiology、Global Health Workforce Issues、Liver Disease and Transplantation

Special attention has been paid to Hepatitis E (HE) prophylaxis for pregnant women due to poor prognosis of HE in this population. We conducted a post-hoc analysis based on the randomized, double-blind, HE vaccine (Hecolin)-controlled phase 3 clinical trial of human papillomavirus (HPV) vaccine (Cecolin) conducted in China. Eligible healthy women aged 18–45 years were randomly assigned to receive three doses of Cecolin or Hecolin and were followed up for 66 months. All the pregnancy-related events throughout the study period were closely followed up. The incidences of adverse events, pregnancy complications, and adverse pregnancy outcomes were analysed based on the vaccine group, maternal age, and interval between vaccination and pregnancy onset. During the study period, 1263 Hecolin receivers and 1260 Cecolin receivers reported 1684 and 1660 pregnancies, respectively. The participants in the two vaccine groups showed similar maternal and neonatal safety profiles, regardless of maternal age. Among the 140 women who were inadvertently vaccinated during pregnancy, the incidences of adverse reactions had no statistical difference between the two groups (31.8% vs 35.1%, p = 0.6782). The proximal exposure to HE vaccination was not associated with a significantly higher risk of abnormal foetal loss (OR 0.80, 95% CI 0.38–1.70) or neonatal abnormality (OR 2.46, 95% CI 0.74–8.18) than that to HPV vaccination, as did distal exposure. Significant difference was not noted between pregnan...