Lancet：手足口病EV71型疫苗安全有效

　　中国学者的一项随机、双盲、安慰剂对照Ⅲ期临床试验结果显示，手足口病（HFMD）重症病例多由肠道病毒71型（EV71）感染引起，病情凶险且病死率高；而EV71灭活疫苗对HFMD有效。相关论文2013年5月29日在线发表于《The Lancet 》 杂志。

　　该研究从中国4个中心纳入6-35月龄健康儿童10245名，随机分为两组，在0和28天分别接种疫苗（n=5120）或安慰剂（n=5125）。观察的主要终点是在56天至14月的期间对EV71相关手足口病和其它疾病的监测。美国临床试验数据库注册编号为NCT01508247。

　　结果显示，疫苗组4907例中，3例出现HFMD，8例相关其它疾病；安慰剂组4939例中，30例HFMD，41例相关其它疾病。在接种后的一年内，疫苗对EV71引起的手足口病的预防达到90%，对EV71相关疾病（包括神经系统并发症）的预防达到80.4%。疫苗组受试者中有62例（1.2%）出现严重不良事件，在安慰剂组中为75例（1.5%，p=0.27）。另外，疫苗组中3644出现不良事件（71.2%），安慰剂组为3603例（70.3%；p=0.33）。

与手足口病相关的拓展阅读：

• Lancet：手足口病EV71型疫苗安全有效
• 北京将进入手足口病发病高峰期 需加强防护
• 手足口病疫苗抗病毒保护机制揭示
• 湖南手足口病发病率下降10月死亡3例
• NEJM：广西研究人员证实脑干脑炎是危重症手足口病主要死因
更多信息请点击：有关手足口病更多资讯

Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
Background
A vaccine for enterovirus 71 (EV71) is needed to address the high burden of disease associated with infection. We assessed the efficacy, safety, immunogenicity, antibody persistence, and immunological correlates of an inactivated alum-adjuvant EV71 vaccine.
Methods
We did a randomised, double-blind, placebo-controlled, phase 3 trial. Healthy children aged 6—35 months from four centres in China were randomly assigned (1:1) to receive vaccine or alum-adjuvant placebo at day 0 and 28, according to a randomisation list (block size 30) generated by an independent statistician. Investigators and participants and their guardians were masked to the assignment. Primary endpoints were EV71-associated hand, foot, and mouth disease (HFMD) and EV71-associated disease during the surveillance period from day 56 to month 14, analysed in the per-protocol population. This study is registered with ClinicalTrials.gov, number NCT01508247.
Findings
10 245 participants were enrolled and assigned: 5120 to vaccine versus 5125 to placebo. 4907 (with three cases of EV71-associated HFMD and eight cases of EV71-associated disease) versus 4939 (with 30 cases of EV71-associated HFMD and 41 cases of EV71-associated disease) were included in the primary efficacy analysis. Vaccine efficacy was 90·0% (95% CI 67·1—96·9) against EV71-associated HFMD (p=0·0001) and 80·4% (95% CI 58·2—90·8) against EV71-associated disease (p<0·0001). Serious adverse events were reported by 62 of 5117 (1·2%) participants in the vaccine group versus 75 of 5123 (1·5%) in the placebo group (p=0·27). Adverse events occurred in 3644 (71·2%) versus 3603 (70·3%; p=0·33).
Interpretation
EV71 vaccine provides high efficacy, satisfactory safety, and sustained immunogenicity.
Funding
China's 12—5 National Major Infectious Disease Program, Beijing Vigoo Biological.