肠道病毒71型灭活疫苗对手足口病重症病例保护效果研究:检测阴性病例对照研究  

Effectiveness of enterovirus A71 inactivated vaccines against severe hand,foot,and mouth disease:A test-negative case-control study

作　　者：张雨桐 崔金朝 刘凤凤[1] 宋杨 刘言哲 张彦平[1] 李中杰 常昭瑞[1] Zhang Yutong;Cui Jinzhao;Liu Fengfeng;Song Yang;Liu Yanzhe;Zhang Yanping;Li Zhongjie;Chang Zhaorui(Division of Infectious Disease,National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases,Chinese Center for Disease Control and Prevention,Beijing 102206,China;School of Population Medicine and Public Health,Beijing Union Medical College,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]中国疾病预防控制中心传染病管理处、传染病监测预警重点实验室,北京102206 [2]中国医学科学院北京协和医学院群医学及公共卫生学院,100730

出　　处：《国际病毒学杂志》2024年第3期177-181,共5页International Journal of Virology

基　　金：北京市自然科学基金(L192014)。

摘　　要：目的评估肠道病毒71型(enterovirus A71,EV-A71)灭活疫苗在真实世界中对EV-A71感染相关重症病例保护效果。方法本研究于2019年1月1日至2021年12月31日在湖南、河南和云南省采用检测阴性设计(test-negative design,TND)病例对照研究评估EV-A71疫苗对手足口病重症病例的保护效果(vaccine effectiveness,VE)。结果本研究共纳入896例6~71月龄的手足口病重症患者,肠道病毒检测阳性率为83.3%,其中,CVA6阳性248例(33.2%),CVA16阳性142例(19.0%),CVA10阳性62例(8.3%),EV-A71阳性52例(7.0%),未分型242例(32.4%)。EV-A71阳性病例中,均未接种EV-A71疫苗,EV-A71疫苗对EV-A71相关的手足口病重症病例的保护效果为100.0%,对CVA16、CVA10和其他肠道病毒感染都无交叉保护作用。结论EV-A71疫苗对EV-A71感染相关的手足口病重症病例具有良好的保护效果。鉴于目前引起手足口病重症病例的肠道病毒优势血清型发生改变,应加紧研发多价疫苗以预防其他肠道病毒感染,尤其是针对CVA6和CVA16等肠道病毒血清型。Objective To evaluate the vaccine effectiveness(VE)of enterovirus A71(EV-A71)inactivated vaccine against severe cases associated with EV-A71.Methods A test-negative design(TND)case-control study was carried out from January 1,2019 to December 31,2021 in Hunan,Henan and Yunnan province to assess the VE of EV-A71 vaccine in preventing severe HFMD.Results In total,896 severe HFMD patients aged 6 to 71 months were included in the study,with a positive enterovirrus test rate of 83.3%.For these patients,248(33.2%)were CVA6-positive,142(19.0%)were CVA16-positive,62(8.3%)were CVA10-positive,52 cases(7.0%)were EV-A71 positive,and 242 cases(32.4%)were not typed.Of the EV-A71-positive cases,none had received EV-A71 vaccine,the EV-71 vaccine against severe cases of EV-A71-associated HFMD was 100%,and did not cross-protect against CVA16,CVA10,or other enterovirus infections.Conclusions The EV-A71 vaccine demonstrated high level VE against severe cases of EV-A71-associated HFMD.Presently,the dominant serotype of enteroviruses in severe cases of HFMD had changed.Under the circumstances,multivalent vaccine should be developed for the prevention of other enteroviral infections,especially for serotypes such as CVA6 and CVA16.

关 键 词：肠道病毒71型灭活疫苗 疫苗保护效果 检测阴性设计 手足口病 重症病例 

分 类 号：R725.1[医药卫生—儿科]