Efficacy, safety and immunogenicity of hexavalent rotavirus vaccine in Chinese infants.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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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
Аннотация
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.