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

作     者：Zhiwei Wu Qingliang Li Yan Liu Huakun Lv Zhaojun Mo Fangjun Li Qingchuan Yu Fei Jin Wei Chen Yong Zhang Teng Huang Xiaosong Hu Wei Xia Jiamei Gao Haisong Zhou Xuan Bai Yueyue Liu Zhenzhen Liang Zhijun Jiang Yingping Chen Jiuwei Zhang Jialiang Du Biao Yang Bo Xing Yantao Xing Ben Dong Qinghai Yang Chen Shi Tingdong Yan Bo Ruan Haiyun Shi Xingliang Fan Dongyang Feng Weigang Lv Dong Zhang Xiangchu Kong Liuyifan Zhou Dinghong Que Hong Chen Zhongbing Chen Xiang Guo Weiwei Zhou Cong Wu Qingrong Zhou Yuqing Liu Jian Qiao Ying Wang Xinguo Li Kai Duan Yuliang Zhao Gelin Xu Xiaoming Yang Zhiwei Wu;Qingliang Li;Yan Liu;Huakun Lv;Zhaojun Mo;Fangjun Li;Qingchuan Yu;Fei Jin;Wei Chen;Yong Zhang;Teng Huang;Xiaosong Hu;Wei Xia;Jiamei Gao;Haisong Zhou;Xuan Bai;Yueyue Liu;Zhenzhen Liang;Zhijun Jiang;Yingping Chen;Jiuwei Zhang;Jialiang Du;Biao Yang;Bo Xing;Yantao Xing;Ben Dong;Qinghai Yang;Chen Shi;Tingdong Yan;Bo Ruan;Haiyun Shi;Xingliang Fan;Dongyang Feng;Weigang Lv;Dong Zhang;Xiangchu Kong;Liuyifan Zhou;Dinghong Que;Hong Chen;Zhongbing Chen;Xiang Guo;Weiwei Zhou;Cong Wu;Qingrong Zhou;Yuqing Liu;Jian Qiao;Ying Wang;Xinguo Li;Kai Duan;Yuliang Zhao;Gelin Xu;Xiaoming Yang

作者机构：Hebei Center for Disease Control and PreventionShijiazhuang050021China National Engineering Technology Research Center for Combined VaccinesWuhan Institute of Biological Product Co.Ltd.Wuhan430207China National Institutes for Food and Drug ControlBeijing100050China Zhejiang Center for Disease Control and PreventionHangzhou310051China Guangxi Zhuang Autonomous Region Center for Disease Control and PreventionNanning530028China Hunan Center for Disease Control and PreventionChangsha410005China Zhengding County Center for Disease Control and PreventionShijiazhuang050800China Daming County Center for Disease Control and PreventionHandan056900China Liucheng County Center for Disease Control and PreventionLiuzhou545200China Xiangtan County Center for Disease Control and PreventionXiangtan411228China Yuhuan County Center for Disease Control and PreventionTaizhou317600China Yongnian County Center for Disease Control and PreventionHandan056000China Rongshui Miao Autonomous County Center for Disease Control and PreventionLiuzhou545300China You County Center for Disease Control and PreventionZhuzhou412315China Longyou County Center for Disease Control and PreventionQuzhou324400China Laishui County Center for Disease Control and PreventionBaoding 074100China Jiangshan County Center for Disease Control and PreventionQuzhou324100China China National Biotec Group Company LimitedNational Engineering Technology Research Center for Combined VaccinesWuhan430207China 

出 版 物：《Virologica Sinica》 (中国病毒学（英文版）)

年 卷 期：2022年第37卷第5期

页      面：724-730页

核心收录：

学科分类：0710[理学-生物学] 1004[医学-公共卫生与预防医学(可授医学、理学学位)] 100401[医学-流行病与卫生统计学] 10[医学] 

基　　金：supported by National Health Commission of the People’s Republic of China (grant number:2019ZX09302059) sponsored and funded by Wuhan Institute of Biological Products Co.,Ltd.,Hubei,China 

主　　题：Rotavirus gastroenteritis(RVGE) Infants Vaccine Efficacy Safety 

摘      要：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)*** the subjects received three oral doses of vaccine four weeks *** 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 *** 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 *** adverse events(AEs)were collected for 30 days after each *** AEs(SAEs)and intussusception cases were collected during the entire *** 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)*** 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 *** was no significant difference in incidences of SAEs in HRV and placebo *** study shows that this hexavalent reassortant rotavirus vaccine is an effective,well-tolerated,and safe vaccine for Chinese infants.