Challenges to licensure of enterovirus 71 vaccines.
Challenges to licensure of enterovirus 71 vaccines.
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DOI：
10.1371/journal.pntd.0001737
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发表时间：
2012
影响因子：
3.8
通讯作者：
Su IJ
中科院分区：
文献类型：
--
作者：
Lee MS;Tseng FC;Wang JR;Chi CY;Chong P;Su IJ
人类肠道病毒通常引起自限性感染，但脊髓灰质炎病毒和肠道病毒71（EV71）除外，后者经常涉及神经系统并发症。EV71疫苗正在人类中进行评估。然而，需要解决EV71疫苗许可证的几个挑战。首先，EV71和柯萨奇病毒A（CA）经常被发现共同传播并引起手足口病（HFMD）。需要可提供针对EV71和流行CA的保护的多价疫苗。其次，婴儿是手足口病疫苗的目标人群，需要进行多国功效试验来证明临床保护作用，并加快手足口病疫苗在儿童中的许可和使用。迫切需要建立一个国际性的肠道病毒监测和临床试验网络。第三，EV71在过去15年中进化迅速。因此，需要进行前瞻性队列研究，以阐明不同EV71基因组之间抗原和遗传变异的临床和流行病学意义，这对疫苗设计至关重要。
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.
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