一个生物反应器生产的EV-A71疫苗的随机试验,用于儿童的流行病控制
Kao-Pin Hwang1, Quang Chan Luong2, Yhu-Chering Huang3
1Department of Paediatric Infectious Diseases, China Medical University Hospital and Children's Hospital, China Medical University, School of Medicine, Taichung City, Taiwan.
NPJ vaccines
|February 12, 2026
概括
一种新的非活化肠道病毒 (EV) A71疫苗,EnVAX-A71,在预防儿童手足口病 (HFMD) 和甲状腺炎方面表现出99.2%的疗效. 这种疫苗可对严重的EV-A71并发症提供显著的保护.
科学领域:
- 病毒学 病毒学
- 疫苗学 疫苗学 疫苗学
- 儿童传染病 儿童传染病
背景情况:
- 肠道病毒 (EV) A71是一种显著的病原体,导致儿童的手足口病 (HFMD) 和羊舌炎,可能导致严重的后果.
- 目前对EV-A71疫情的控制措施有限,这凸显了对有效疫苗的需求.
研究的目的:
- 为了评估EnVAX-A71的疗效和安全性,一个含辅助剂的非活化EV-A71疫苗,在儿童群体中.
- 评估由EnVAX-A71诱导的免疫性和血清保护的持续时间.
主要方法:
- 一个随机,双盲,安慰剂控制的第三期试验,涉及4011名2-71个月的儿童在台湾和越南.
- 主要终点:实验室证实了与EV-A71相关的HFMD/herpangina. 二级终点包括血清保护率和安全性评估.
- 随访持续时间为1-2年,中位数为接种疫苗后490天.
主要成果:
- 针对EV-A71相关的HFMD/herpangina的疫苗疗效为99.2% (95% CI: 94.3-99.9).
- 血清保护率 (中和抗体标位≥1:32) 在第56天达到98.7%,并在一年内保持在98%以上.
- 在预防住院治疗方面观察到100%的疗效 (0 vs 19 个病例),疫苗和安慰剂组之间的安全性概况相似.
结论:
- EnVAX-A71对于预防EV-A71相关的HFMD和幼儿膜炎是非常有效和安全的.
- 该疫苗诱导了强大且持续的血清保护,支持其用于流行性EV-A71控制.
- 这些发现提供了强有力的证据,证明EnVAX-A71在公共卫生策略中对EV-A71的有用性.
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