Two- year efficacy and immunogenicity of Sinovac Enterovirus 71 vaccine against hand, foot and mouth disease in children
Two- year efficacy and immunogenicity of Sinovac Enterovirus 71 vaccine against hand, foot and mouth disease in children
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DOI：
10.1586/14760584.2016.1096782
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发表时间：
2016-01-02
影响因子：
6.2
通讯作者：
Zhu, Feng-Cai
中科院分区：
文献类型：
--
作者：
Li, Jing-Xin;Song, Yu-Fei;Zhu, Feng-Cai
目的：评价新诺华71型肠道病毒(EV71)疫苗2年内的免疫效果和免疫原性。方法：我们对我们最初的随机试验进行了跟踪研究，共有10,077名参与者，他们被随机接受EV71疫苗或安慰剂，比例为1：1，并跟踪观察了14个月。延长的随访研究持续了12个月，EV71相关的手足口病(HFMD)是主要终点。结果：EV71疫苗对EV71相关手足口病的有效率为95.1%(95%CI为63.6，99.3)，2年总有效率为94.7%(95%CI为87.8，97.6)。EV71疫苗在参与者中诱导了持续高水平的中和抗体，没有发现与接种疫苗有关的严重不良事件。结论：Sinovac EV71疫苗对EV71相关手足口病的保护力可持续长达2年。
Objectives: To evaluate the efficacy and immunogenicity of the Sinovac Enterovirus 71 (EV71) vaccine for up to two years. Methods: We did a follow-up study of our initial randomized trial in 10,077 participants, who were randomized to receive EV71 vaccine or placebo in a 1:1 ratio and followed for 14 months. The extended follow-up study lasted for another 12months and EV71-associated hand, foot, and mouth disease (HFMD) was the primary endpoint. Results: The EV71 vaccine showed an efficacy of 95.1% (95%CI 63.6, 99.3) against EV71-associated HFMD during the extended follow-up and an overall efficacy of 94.7% (95%CI 87.8, 97.6) for two years. The EV71 vaccine elicited a sustained high level of neutralizing antibodies in participants, and no serious adverse event was judged to be related to the vaccination. Conclusion: The Sinovac EV71 vaccine could provide a sustained high protection against EV71-associated HFMDs for up to 2years.