Efficacy, safety and immunogenicity of hexavalent rotavirus vaccine in Chinese infants

• Published in: Virologica Sinica Vol. 37; no. 5; pp. 724 - 730
• Main Authors: Wu, Zhiwei, Li, Qingliang, Liu, Yan, Lv, Huakun, Mo, Zhaojun, Li, Fangjun, Yu, Qingchuan, Jin, Fei, Chen, Wei, Zhang, Yong, Huang, Teng, Hu, Xiaosong, Xia, Wei, Gao, Jiamei, Zhou, Haisong, Bai, Xuan, Liu, Yueyue, Liang, Zhenzhen, Jiang, Zhijun, Chen, Yingping, Zhang, Jiuwei, Du, Jialiang, Yang, Biao, Xing, Bo, Xing, Yantao, Dong, Ben, Yang, Qinghai, Shi, Chen, Yan, Tingdong, Ruan, Bo, Shi, Haiyun, Fan, Xingliang, Feng, Dongyang, Lv, Weigang, Zhang, Dong, Kong, Xiangchu, Zhou, Liuyifan, Que, Dinghong, Chen, Hong, Chen, Zhongbing, Guo, Xiang, Zhou, Weiwei, Wu, Cong, Zhou, Qingrong, Liu, Yuqing, Qiao, Jian, Wang, Ying, Li, Xinguo, Duan, Kai, Zhao, Yuliang, Xu, Gelin, Yang, Xiaoming
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01.10.2022; Wuhan Institute of Virology, Chinese Academy of Sciences
• Subjects: Efficacy; Infants; Rotavirus gastroenteritis (RVGE); Safety; Vaccine; Efficacy; Infants; Vaccine; Rotavirus gastroenteritis (RVGE); Safety
• ISSN: 1995-820X; 1674-0769; 1995-820X
• DOI: 10.1016/j.virs.2022.07.011

A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy and safety of a hexavalent live human-bovine reassortant rotavirus vaccine (HRV) against rotavirus gastroenteritis (RVGE). A total of 6400 participants aged 6–12 weeks were enrolled and randomly assigned to either HRV (n ​= ​3200) or placebo (n ​= ​3200) group. All the subjects received three oral doses of vaccine four weeks apart. The vaccine efficacy (VE) against RVGE caused by rotavirus serotypes contained in HRV was evaluated from 14 days after three doses of administration up until the end of the second rotavirus season. VE against severe RVGE, VE against RVGE hospitalization caused by serotypes contained in HRV, and VE against RVGE, severe RVGE, and RVGE hospitalization caused by natural infection of any serotype of rotavirus were also investigated. All adverse events (AEs) were collected for 30 days after each dose. Serious AEs (SAEs) and intussusception cases were collected during the entire study. Our data showed that VE against RVGE caused by serotypes contained in HRV was 69.21% (95%CI: 53.31–79.69). VE against severe RVGE and RVGE hospitalization caused by serotypes contained in HRV were 91.36% (95%CI: 78.45–96.53) and 89.21% (95%CI: 64.51–96.72) respectively. VE against RVGE, severe RVGE, and RVGE hospitalization caused by natural infection of any serotype of rotavirus were 62.88% (95%CI: 49.11–72.92), 85.51% (95%CI: 72.74–92.30) and 83.68% (95%CI: 61.34–93.11). Incidences of AEs from the first dose to one month post the third dose in HRV and placebo groups were comparable. There was no significant difference in incidences of SAEs in HRV and placebo groups. This study shows that this hexavalent reassortant rotavirus vaccine is an effective, well-tolerated, and safe vaccine for Chinese infants. •A multicenter, double-blind, phase III clinical trial for the efficacy and safety of hexavalent rotavirus vaccine (HRV).•The vaccine efficacy against rotavirus gastroenteritis caused by serotypes contained in HRV was 69.21%.•The efficacy against severe rotavirus gastroenteritis and hospitalization caused by serotypesin HRV were 91.36% and 89.21%.•No significant difference between the incidences of adverse events and severe adverse events in HRV and placebo group.•This hexavalent live human-bovine reassortant rotavirus vaccine iseffective, well tolerated and safe in Chinese infants.