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Volume 37 Issue 5
October 2022
    Citation: 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. Efficacy, safety and immunogenicity of hexavalent rotavirus vaccine in Chinese infants .VIROLOGICA SINICA, 2022, 37(5) : 724-730.  http://dx.doi.org/10.1016/j.virs.2022.07.011
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    Efficacy, safety and immunogenicity of hexavalent rotavirus vaccine in Chinese infants

    • a Hebei Center for Disease Control and Prevention, Shijiazhuang, 050021, China;

    • b National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China;

    • c National Institutes for Food and Drug Control, Beijing, 100050, China;

    • d Zhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China;

    • e Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, 530028, China;

    • f Hunan Center for Disease Control and Prevention, Changsha, 410005, China;

    • g Zhengding County Center for Disease Control and Prevention, Shijiazhuang, 050800, China;

    • h Daming County Center for Disease Control and Prevention, Handan, 056900, China;

    • i Liucheng County Center for Disease Control and Prevention, Liuzhou, 545200, China;

    • j Xiangtan County Center for Disease Control and Prevention, Xiangtan, 411228, China;

    • k Yuhuan County Center for Disease Control and Prevention, Taizhou, 317600, China;

    • l Yongnian County Center for Disease Control and Prevention, Handan, 056000, China;

    • m Rongshui Miao Autonomous County Center for Disease Control and Prevention, Liuzhou, 545300, China;

    • n You County Center for Disease Control and Prevention, Zhuzhou, 412315, China;

    • o Longyou County Center for Disease Control and Prevention, Quzhou, 324400, China;

    • p Laishui County Center for Disease Control and Prevention, Baoding 074100, China;

    • q Jiangshan County Center for Disease Control and Prevention, Quzhou, 324100, China;

    • r China National Biotec Group Company Limited, National Engineering Technology Research Center for Combined Vaccines, Wuhan, 430207, China

    • 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.
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      11. Li, R.C., Huang, T., Li, Y., Luo, D., Tao, J., Fu, B., Si, G., Nong, Y., Mo, Z., Liao, X., Luan, I., Tang, H., Rathi, N., Karkada, N., Han, H.H., 2014. Human rotavirus vaccine(RIX4414) efficacy in the first two years of life:a randomized, placebo-controlled trial in China. Hum. Vaccines Immunother. 10, 11-18.

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      14. Mo, Z., Mo, Y., Li, M., Tao, J., Yang, X., Kong, J., Wei, D., Fu, B., Liao, X., Chu, J., Qiu, Y., Hille, D.A., Nelson, M., Kaplan, S.S., 2017. Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants:a randomized, double-blind, placebo-controlled trial. Vaccine 35, 5897-5904.

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      22. World Health Organization (WHO), 2007. Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines (oral), Annex 3, TRS No 941. https://www.who.int/publications/m/item/oral-live-attenuated-rotavirus-vaccines-anne x-3-trs-no-941.

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

        Corresponding author: Yuliang Zhao, yuliang_zh@163.com
        Corresponding author: Gelin Xu, gelinxu@qq.com
        Corresponding author: Xiaoming Yang, yangxiaoming@sinopharm.com
      • a Hebei Center for Disease Control and Prevention, Shijiazhuang, 050021, China;
      • b National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China;
      • c National Institutes for Food and Drug Control, Beijing, 100050, China;
      • d Zhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China;
      • e Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, 530028, China;
      • f Hunan Center for Disease Control and Prevention, Changsha, 410005, China;
      • g Zhengding County Center for Disease Control and Prevention, Shijiazhuang, 050800, China;
      • h Daming County Center for Disease Control and Prevention, Handan, 056900, China;
      • i Liucheng County Center for Disease Control and Prevention, Liuzhou, 545200, China;
      • j Xiangtan County Center for Disease Control and Prevention, Xiangtan, 411228, China;
      • k Yuhuan County Center for Disease Control and Prevention, Taizhou, 317600, China;
      • l Yongnian County Center for Disease Control and Prevention, Handan, 056000, China;
      • m Rongshui Miao Autonomous County Center for Disease Control and Prevention, Liuzhou, 545300, China;
      • n You County Center for Disease Control and Prevention, Zhuzhou, 412315, China;
      • o Longyou County Center for Disease Control and Prevention, Quzhou, 324400, China;
      • p Laishui County Center for Disease Control and Prevention, Baoding 074100, China;
      • q Jiangshan County Center for Disease Control and Prevention, Quzhou, 324100, China;
      • r China National Biotec Group Company Limited, National Engineering Technology Research Center for Combined Vaccines, Wuhan, 430207, China
      • Received Date: 16 April 2022
      • Accepted Date: 19 July 2022

      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.

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