PMID- 35926726
OWN - NLM
STAT- MEDLINE
DCOM- 20221018
LR  - 20221022
IS  - 1995-820X (Electronic)
IS  - 1674-0769 (Print)
IS  - 1995-820X (Linking)
VI  - 37
IP  - 5
DP  - 2022 Oct
TI  - Efficacy, safety and immunogenicity of hexavalent rotavirus vaccine in Chinese 
      infants.
PG  - 724-730
LID - S1995-820X(22)00135-3 [pii]
LID - 10.1016/j.virs.2022.07.011 [doi]
AB  - 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.
CI  - Copyright (c) 2022 The Authors. Publishing services by Elsevier B.V. All rights 
      reserved.
FAU - Wu, Zhiwei
AU  - Wu Z
AD  - Hebei Center for Disease Control and Prevention, Shijiazhuang, 050021, China.
FAU - Li, Qingliang
AU  - Li Q
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Liu, Yan
AU  - Liu Y
AD  - National Institutes for Food and Drug Control, Beijing, 100050, China.
FAU - Lv, Huakun
AU  - Lv H
AD  - Zhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China.
FAU - Mo, Zhaojun
AU  - Mo Z
AD  - Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, 
      Nanning, 530028, China.
FAU - Li, Fangjun
AU  - Li F
AD  - Hunan Center for Disease Control and Prevention, Changsha, 410005, China.
FAU - Yu, Qingchuan
AU  - Yu Q
AD  - National Institutes for Food and Drug Control, Beijing, 100050, China.
FAU - Jin, Fei
AU  - Jin F
AD  - Hebei Center for Disease Control and Prevention, Shijiazhuang, 050021, China.
FAU - Chen, Wei
AU  - Chen W
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Zhang, Yong
AU  - Zhang Y
AD  - National Institutes for Food and Drug Control, Beijing, 100050, China.
FAU - Huang, Teng
AU  - Huang T
AD  - Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, 
      Nanning, 530028, China.
FAU - Hu, Xiaosong
AU  - Hu X
AD  - Zhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China.
FAU - Xia, Wei
AU  - Xia W
AD  - Hunan Center for Disease Control and Prevention, Changsha, 410005, China.
FAU - Gao, Jiamei
AU  - Gao J
AD  - National Institutes for Food and Drug Control, Beijing, 100050, China.
FAU - Zhou, Haisong
AU  - Zhou H
AD  - Zhengding County Center for Disease Control and Prevention, Shijiazhuang, 050800, 
      China.
FAU - Bai, Xuan
AU  - Bai X
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Liu, Yueyue
AU  - Liu Y
AD  - National Institutes for Food and Drug Control, Beijing, 100050, China.
FAU - Liang, Zhenzhen
AU  - Liang Z
AD  - Zhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China.
FAU - Jiang, Zhijun
AU  - Jiang Z
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Chen, Yingping
AU  - Chen Y
AD  - Zhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China.
FAU - Zhang, Jiuwei
AU  - Zhang J
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Du, Jialiang
AU  - Du J
AD  - National Institutes for Food and Drug Control, Beijing, 100050, China.
FAU - Yang, Biao
AU  - Yang B
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Xing, Bo
AU  - Xing B
AD  - Zhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China.
FAU - Xing, Yantao
AU  - Xing Y
AD  - Daming County Center for Disease Control and Prevention, Handan, 056900, China.
FAU - Dong, Ben
AU  - Dong B
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Yang, Qinghai
AU  - Yang Q
AD  - Liucheng County Center for Disease Control and Prevention, Liuzhou, 545200, 
      China.
FAU - Shi, Chen
AU  - Shi C
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Yan, Tingdong
AU  - Yan T
AD  - Xiangtan County Center for Disease Control and Prevention, Xiangtan, 411228, 
      China.
FAU - Ruan, Bo
AU  - Ruan B
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Shi, Haiyun
AU  - Shi H
AD  - Yuhuan County Center for Disease Control and Prevention, Taizhou, 317600, China.
FAU - Fan, Xingliang
AU  - Fan X
AD  - National Institutes for Food and Drug Control, Beijing, 100050, China.
FAU - Feng, Dongyang
AU  - Feng D
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Lv, Weigang
AU  - Lv W
AD  - Yongnian County Center for Disease Control and Prevention, Handan, 056000, China.
FAU - Zhang, Dong
AU  - Zhang D
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Kong, Xiangchu
AU  - Kong X
AD  - Rongshui Miao Autonomous County Center for Disease Control and Prevention, 
      Liuzhou, 545300, China.
FAU - Zhou, Liuyifan
AU  - Zhou L
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Que, Dinghong
AU  - Que D
AD  - You County Center for Disease Control and Prevention, Zhuzhou, 412315, China.
FAU - Chen, Hong
AU  - Chen H
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Chen, Zhongbing
AU  - Chen Z
AD  - Longyou County Center for Disease Control and Prevention, Quzhou, 324400, China.
FAU - Guo, Xiang
AU  - Guo X
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Zhou, Weiwei
AU  - Zhou W
AD  - Laishui County Center for Disease Control and Prevention, Baoding 074100, China.
FAU - Wu, Cong
AU  - Wu C
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Zhou, Qingrong
AU  - Zhou Q
AD  - Jiangshan County Center for Disease Control and Prevention, Quzhou, 324100, 
      China.
FAU - Liu, Yuqing
AU  - Liu Y
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Qiao, Jian
AU  - Qiao J
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Wang, Ying
AU  - Wang Y
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Li, Xinguo
AU  - Li X
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Duan, Kai
AU  - Duan K
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
FAU - Zhao, Yuliang
AU  - Zhao Y
AD  - Hebei Center for Disease Control and Prevention, Shijiazhuang, 050021, China. 
      Electronic address: yuliang_zh@163.com.
FAU - Xu, Gelin
AU  - Xu G
AD  - National Engineering Technology Research Center for Combined Vaccines, Wuhan 
      Institute of Biological Product Co., Ltd., Wuhan, 430207, China. Electronic 
      address: gelinxu@qq.com.
FAU - Yang, Xiaoming
AU  - Yang X
AD  - China National Biotec Group Company Limited, National Engineering Technology 
      Research Center for Combined Vaccines, Wuhan, 430207, China. Electronic address: 
      yangxiaoming@sinopharm.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220801
PL  - Netherlands
TA  - Virol Sin
JT  - Virologica Sinica
JID - 101514185
RN  - 0 (Rotavirus Vaccines)
RN  - 0 (Vaccines, Attenuated)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Administration, Oral
MH  - Animals
MH  - Cattle
MH  - China
MH  - *Enterovirus Infections
MH  - *Gastroenteritis/epidemiology
MH  - Humans
MH  - Infant
MH  - *Rotavirus
MH  - *Rotavirus Infections/epidemiology/prevention & control
MH  - *Rotavirus Vaccines/adverse effects
MH  - Vaccination
MH  - Vaccines, Attenuated
MH  - Vaccines, Combined
PMC - PMC9583109
OTO - NOTNLM
OT  - Efficacy
OT  - Infants
OT  - Rotavirus gastroenteritis (RVGE)
OT  - Safety
OT  - Vaccine
EDAT- 2022/08/05 06:00
MHDA- 2022/10/19 06:00
PMCR- 2022/08/01
CRDT- 2022/08/04 19:25
PHST- 2022/04/16 00:00 [received]
PHST- 2022/07/19 00:00 [accepted]
PHST- 2022/08/05 06:00 [pubmed]
PHST- 2022/10/19 06:00 [medline]
PHST- 2022/08/04 19:25 [entrez]
PHST- 2022/08/01 00:00 [pmc-release]
AID - S1995-820X(22)00135-3 [pii]
AID - 10.1016/j.virs.2022.07.011 [doi]
PST - ppublish
SO  - Virol Sin. 2022 Oct;37(5):724-730. doi: 10.1016/j.virs.2022.07.011. Epub 2022 Aug 
      1.