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Randomized Controlled Trial
. 2022 Oct;37(5):724-730.
doi: 10.1016/j.virs.2022.07.011. Epub 2022 Aug 1.

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

Zhiwei Wu  1 , Qingliang Li  2 , Yan Liu  3 , Huakun Lv  4 , Zhaojun Mo  5 , Fangjun Li  6 , Qingchuan Yu  3 , Fei Jin  1 , Wei Chen  2 , Yong Zhang  3 , Teng Huang  5 , Xiaosong Hu  4 , Wei Xia  6 , Jiamei Gao  3 , Haisong Zhou  7 , Xuan Bai  2 , Yueyue Liu  3 , Zhenzhen Liang  4 , Zhijun Jiang  2 , Yingping Chen  4 , Jiuwei Zhang  2 , Jialiang Du  3 , Biao Yang  2 , Bo Xing  4 , Yantao Xing  8 , Ben Dong  2 , Qinghai Yang  9 , Chen Shi  2 , Tingdong Yan  10 , Bo Ruan  2 , Haiyun Shi  11 , Xingliang Fan  3 , Dongyang Feng  2 , Weigang Lv  12 , Dong Zhang  2 , Xiangchu Kong  13 , Liuyifan Zhou  2 , Dinghong Que  14 , Hong Chen  2 , Zhongbing Chen  15 , Xiang Guo  2 , Weiwei Zhou  16 , Cong Wu  2 , Qingrong Zhou  17 , Yuqing Liu  2 , Jian Qiao  2 , Ying Wang  2 , Xinguo Li  2 , Kai Duan  2 , Yuliang Zhao  18 , Gelin Xu  19 , Xiaoming Yang  20
Affiliations
Randomized Controlled Trial

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

Zhiwei Wu et al. Virol Sin. 2022 Oct.

Abstract

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.

Keywords: Efficacy; Infants; Rotavirus gastroenteritis (RVGE); Safety; Vaccine.

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Figures

Fig. 1
Fig. 1
Study profile.
Fig. 2
Fig. 2
Seroconversion rate of IgA among HRV and placebo groups post three doses of vaccination based on immunogenicity per protocol subjects.
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