Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial
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 (Cec...
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Taylor & Francis Group
2023-12-01
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| Series: | Emerging Microbes and Infections |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/22221751.2023.2185456 |
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| author | Guohua Zhong Chunlan Zhuang Xiaowen Hu Qi Chen Zhaofeng Bi Xinhua Jia Siying Peng Yufei Li Yue Huang Qiufen Zhang Ying Hong Youlin Qiao Yingying Su Huirong Pan Ting Wu Lihui Wei Shoujie Huang Jun Zhang Ningshao Xia |
| author_facet | Guohua Zhong Chunlan Zhuang Xiaowen Hu Qi Chen Zhaofeng Bi Xinhua Jia Siying Peng Yufei Li Yue Huang Qiufen Zhang Ying Hong Youlin Qiao Yingying Su Huirong Pan Ting Wu Lihui Wei Shoujie Huang Jun Zhang Ningshao Xia |
| author_sort | Guohua Zhong |
| collection | DOAJ |
| description | 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 pregnancies with proximal and distal exposure to HE vaccination. Conclusively, HE vaccination during or shortly before pregnancy is not associated with increased risks for both the pregnant women and pregnancy outcomes. |
| format | Article |
| id | doaj-art-acf452cf809b492f9f8862c9a34da8e4 |
| institution | OA Journals |
| issn | 2222-1751 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Emerging Microbes and Infections |
| spelling | doaj-art-acf452cf809b492f9f8862c9a34da8e42025-08-20T01:49:27ZengTaylor & Francis GroupEmerging Microbes and Infections2222-17512023-12-0112110.1080/22221751.2023.2185456Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trialGuohua Zhong0Chunlan Zhuang1Xiaowen Hu2Qi Chen3Zhaofeng Bi4Xinhua Jia5Siying Peng6Yufei Li7Yue Huang8Qiufen Zhang9Ying Hong10Youlin Qiao11Yingying Su12Huirong Pan13Ting Wu14Lihui Wei15Shoujie Huang16Jun Zhang17Ningshao Xia18State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaXiamen Innovax Biotech Company, Xiamen, People’s Republic of ChinaThe Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, People’s Republic of ChinaNational Cancer Center, National Center for Cancer Clinical Research, the Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaXiamen Innovax Biotech Company, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaPeking University People’s Hospital, Beijing, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, People’s Republic of ChinaSpecial 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 pregnancies with proximal and distal exposure to HE vaccination. Conclusively, HE vaccination during or shortly before pregnancy is not associated with increased risks for both the pregnant women and pregnancy outcomes.https://www.tandfonline.com/doi/10.1080/22221751.2023.2185456Hepatitis E vaccineHecolinhuman papillomavirus vaccinepregnancysafety |
| spellingShingle | Guohua Zhong Chunlan Zhuang Xiaowen Hu Qi Chen Zhaofeng Bi Xinhua Jia Siying Peng Yufei Li Yue Huang Qiufen Zhang Ying Hong Youlin Qiao Yingying Su Huirong Pan Ting Wu Lihui Wei Shoujie Huang Jun Zhang Ningshao Xia Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial Emerging Microbes and Infections Hepatitis E vaccine Hecolin human papillomavirus vaccine pregnancy safety |
| title | Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial |
| title_full | Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial |
| title_fullStr | Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial |
| title_full_unstemmed | Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial |
| title_short | Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial |
| title_sort | safety of hepatitis e vaccination for pregnancy a post hoc analysis of a randomized double blind controlled phase 3 clinical trial |
| topic | Hepatitis E vaccine Hecolin human papillomavirus vaccine pregnancy safety |
| url | https://www.tandfonline.com/doi/10.1080/22221751.2023.2185456 |
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