肠道病毒 71 型疫苗的许可挑战。
Challenges to licensure of enterovirus 71 vaccines.
机构信息
National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes, Taiwan.
出版信息
PLoS Negl Trop Dis. 2012;6(8):e1737. doi: 10.1371/journal.pntd.0001737. Epub 2012 Aug 28.
Abstract
Human enteroviruses usually cause self-limited infections except polioviruses and enterovirus 71 (EV71), which frequently involve neurological complications. EV71 vaccines are being evaluated in humans. However, several challenges to licensure of EV71 vaccines need to be addressed. Firstly, EV71 and coxsackievirus A (CA) are frequently found to co-circulate and cause hand-foot-mouth disease (HFMD). A polyvalent vaccine that can provide protection against EV71 and prevalent CA are desirable. Secondly, infants are the target population of HFMD vaccines and it would need multi-national efficacy trials to prove clinical protection and speed up the licensure and usage of HFMD vaccines in children. An international network for enterovirus surveillance and clinical trials is urgently needed. Thirdly, EV71 is found to evolve quickly in the past 15 years. Prospective cohort studies are warranted to clarify clinical and epidemiological significances of the antigenic and genetic variations between different EV71 genogroups, which is critical for vaccine design.
摘要
人类肠道病毒通常会引起自限性感染，除了脊髓灰质炎病毒和肠道病毒 71 型（EV71）以外，这两种病毒常引起神经并发症。EV71 疫苗正在进行人体试验。然而，要获得 EV71 疫苗的许可，还需要解决几个挑战。首先，EV71 和柯萨奇病毒 A（CA）经常共同循环并引起手足口病（HFMD）。人们希望有一种多价疫苗，既能预防 EV71，又能预防常见的 CA。其次，婴幼儿是 HFMD 疫苗的目标人群，需要进行跨国疗效试验来证明临床保护效果，从而加快 HFMD 疫苗在儿童中的许可和使用。迫切需要建立一个肠道病毒监测和临床试验的国际网络。第三，过去 15 年来发现 EV71 进化迅速。有必要进行前瞻性队列研究，以阐明不同 EV71 基因型之间抗原和遗传变异的临床和流行病学意义，这对于疫苗设计至关重要。
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