Wei Mingwei, Meng Fanyue, Wang Shiyuan, Li Jingxin, Zhang Yuntao, Mao Qunying, Hu Yuemei, Liu Pei, Shi Nianmin, Tao Hong, Chu Kai, Wang Yuxiao, Liang Zhenglun, Li Xiuling, Zhu Fengcai
Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University.
Jiangsu Province Center for Disease Control and Prevention.
J Infect Dis. 2017 Jan 1;215(1):56-63. doi: 10.1093/infdis/jiw502. Epub 2016 Oct 17.
This study evaluated the 2-year efficacy, immunogenicity, and safety of the Vigoo enterovirus 71 (EV71) vaccine.
In an initial phase 3 study, we randomly assigned healthy infants and children aged 6-35 months (ratio, 1:1) to receive 2 doses of either EV71 vaccine (5120 participants) or placebo (5125 participants) at days 0 and 28, and followed them for 12 months after vaccination. In this extended follow-up study, we continued to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine for up to 2 years.
Overall efficacy was 94.84% (95% confidence interval [CI], 83.53%-98.38%) during the 2-year follow-up period (P < .0001), and the vaccine efficacy during the second year was 100.00% (95% CI, 84.15%-100.00%) against EV71-associated hand-foot-and-mouth disease (HFMD; P < .0001). Geometric mean titers of neutralizing antibody in participants remained high during the 2-year follow-up period, and no vaccine-related serious adverse events were recorded.
Two doses of Vigoo EV71 vaccine could provide sustained protection against EV71-associated HFMD in healthy Chinese children.
NCT01508247.
本研究评估了维可儿肠道病毒71型（EV71）疫苗的2年疗效、免疫原性和安全性。
在一项初始的3期研究中，我们将6至35个月的健康婴幼儿（比例为1:1）随机分配，在第0天和第28天接受2剂EV71疫苗（5120名参与者）或安慰剂（5125名参与者），并在接种疫苗后对他们进行12个月的随访。在这项延长随访研究中，我们继续评估EV71疫苗长达2年的疗效、免疫原性和安全性。
在2年随访期内，总体疗效为94.84%（95%置信区间[CI]，83.53%-98.38%）（P <.0001），第二年针对EV71相关手足口病（HFMD）的疫苗效力为100.00%（95%CI，84.15%-100.00%）（P <.0001）。参与者体内中和抗体的几何平均滴度在2年随访期内保持较高水平，且未记录到与疫苗相关的严重不良事件。
两剂维可儿EV71疫苗可为中国健康儿童提供针对EV71相关HFMD的持续保护。
NCT01508247。
