肠道病毒71型疫苗上市后疫苗保护效果和免疫原性分析

Analysis on post-marketing effectiveness and immunogenicity of enterovirus-A71 vaccine

目的分析肠道病毒71型(EV-A71)疫苗上市接种后的疫苗保护效果和免疫原性。方法采用队列研究于2017年10-12月在上海市静安区招募符合纳入标准的预防接种门诊受种者为研究对象,按0、30 d程序接种疫苗者纳入接种组,不接种疫苗者纳入对照组,随访观察1年,评估疫苗保护效果和接种2剂次疫苗后抗体水平及阳转率。结果共纳入3018名8~20月龄的儿童,接种组1211人,对照组1807人,经过1年随访,EV-A71疫苗对EV-A71感染引起的手足口病保护率为100.00%(95%CI:-66.99%~100.00%)。接种组中124人检测了中和抗体,接种首剂疫苗后60 d抗体几何平均滴度(GMT)为41.76(95%CI:35.60~49.34),接种后365 d GMT为28.44(95%CI:23.59~34.54)。结论EV-A71疫苗对于儿童有良好的免疫应答,EV-A71感染引起的手足口病病例较少,需进一步观察。

Objective To analyze the effectiveness and immunogenicity of enterovirus-A71(EV-A71)vaccine in immunization program.Methods A cohort study was conducted in immunization clinics in Jing'an district in Shanghai from October to December 2017.Children who received EV-A71 vaccine based on a 2-dose schedule(on day 0 and day 30)were enrolled as vaccine group and those who received no EV-A71 vaccine were enrolled as control group.After 1-year follow-up,the effectiveness and neutralizing antibody level and the positive results of antibody immunogenicity in vaccine group were analyzed.Results A total of 3018 children aged 8-20 months were enrolled,in whom 1211 were in vaccine group and 1807 were in control group.The vaccine effectiveness was 100%against EV-A71-associated hand,foot,and mouth disease(HFMD)indicated by 1 year follow-up(95%CI:-66.99%-100.00%).The geometric mean titer of neutralizing antibody(GMT)was 41.76(95%CI:35.60-49.34)at day 60 and 28.44(95%CI:23.59-34.54)at day 365 in 124 children in vaccine group.Conclusions In children,EV-A71 vaccine elicited EV-A71-specific immune response.Less EV-A71-associated HFMD cases have been observed,further observation is needed.