健康儿童中使用的灭活肠道病毒 71 型疫苗。
An inactivated enterovirus 71 vaccine in healthy children.
机构信息
From Guangxi Province Center for Disease Control and Prevention, Nanning (R.L., Z.M., Y. Li, T.H., Y.N.), Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming (L.L., Y.Z., Jingjing Wang, L.J., C.D., Y.C., Z.X., L.W., Y. Liao, Y. Liang, J.L., H.Z., R.N., L.G., J.P., E.Y., L.S., P.C., H.S., Q.L.), Key Laboratory Medical Molecular Virology, Ministries of Education and Health, and the Institutes of Biomedical Science, Shanghai Medical College, Fudan University, Shanghai (X.W.), Department of Health Statistics, Fourth Military Medical University, Xi'an (J.X., Z.J.), and National Institutes for Food and Drug Control, Beijing (Z.L., Q.M., Junzhi Wang) - all in China.
出版信息
N Engl J Med. 2014 Feb 27;370(9):829-37. doi: 10.1056/NEJMoa1303224.
BACKGROUND
Enterovirus 71 (EV71) is a major cause of hand, foot, and mouth disease in children and may be fatal. A vaccine against EV71 is needed.
METHODS
We conducted a randomized, double-blind, placebo-controlled phase 3 trial involving healthy children 6 to 71 months of age in Guangxi Zhuang Autonomous Region, China. Two doses of an inactivated EV71 vaccine or placebo were administered intramuscularly, with a 4-week interval between doses, and children were monitored for up to 11 months. The primary end point was protection against hand, foot, and mouth disease caused by EV71.
RESULTS
A total of 12,000 children were randomly assigned to receive vaccine or placebo. Serum neutralizing antibodies were assessed in 549 children who received the vaccine. The seroconversion rate was 100% 4 weeks after the two vaccinations, with a geometric mean titer of 170.6. Over the course of two epidemic seasons, the vaccine efficacy was 97.4% (95% confidence interval [CI], 92.9 to 99.0) according to the intention-to-treat analysis and 97.3% (95% CI, 92.6 to 99.0) according to the per-protocol analysis. Adverse events, such as fever (which occurred in 41.6% of the participants who received vaccine vs. 35.2% of those who received placebo), were significantly more common in the week after vaccination among children who received the vaccine than among those who received placebo.
CONCLUSIONS
The inactivated EV71 vaccine elicited EV71-specific immune responses and protection against EV71-associated hand, foot, and mouth disease. (Funded by the National Basic Research Program and others; ClinicalTrials.gov number, NCT01569581.).
背景
肠道病毒 71 型（EV71）是引起儿童手足口病的主要病原体，可导致死亡。因此需要研发 EV71 疫苗。
方法
我们在中国广西壮族自治区开展了一项随机、双盲、安慰剂对照的 3 期临床试验，纳入了 6 至 71 月龄的健康儿童。儿童肌肉注射 2 剂灭活 EV71 疫苗或安慰剂，间隔 4 周，随访 11 个月。主要终点为预防由 EV71 引起的手足口病。
结果
共有 12000 名儿童被随机分配接受疫苗或安慰剂。549 名儿童接受了疫苗，评估了血清中和抗体。两剂疫苗接种后 4 周，血清转化率为 100%，几何平均滴度为 170.6。在两个流行季节期间，根据意向治疗分析，疫苗的疗效为 97.4%（95%置信区间，92.9 至 99.0），根据方案分析为 97.3%（95%置信区间，92.6 至 99.0）。疫苗组参与者在接种后一周内更常出现发热等不良反应（疫苗组 41.6%，安慰剂组 35.2%）。
结论
灭活 EV71 疫苗可诱导产生 EV71 特异性免疫应答，并预防 EV71 相关手足口病。（由国家基础研究计划等资助；ClinicalTrials.gov 注册号，NCT01569581。）
Zotero 插件