National Institutes for Food and Drug Control, Beijing, 100050, China.
Front Med. 2013 Mar;7(1):111-21. doi: 10.1007/s11684-012-0237-z. Epub 2012 Dec 17.
Enterovirus 71 (EV71) infections, which can cause severe complications, have become one of the serious public health issues in the Western Pacific region and China. To date, a number of pharmaceutical companies and institutes have initiated the research and development of EV71 vaccines as a countermeasure. As is the case with innovative vaccine development, there are several critical bottlenecks in EV71 vaccine development that must be overcome before the clinical trials, including the selection of vaccine strain, standardization of the procedure for quantifying neutralizing antibody (NTAb) and antigen, establishment and application of a reference standard and biological standards, development of animal models for the evaluation of protective efficacy, and identification of the target patient population. To tackle these technical obstacles, researchers in Mainland of China have conducted a series of studies concerning the screening of vaccine strains and the establishment of criteria, biological standards and detection methods, thereby advancing EV71 vaccine development. This review summarizes recent worldwide progress on the quality control and evaluation of EV71 vaccines.
肠道病毒 71 型（EV71）感染可导致严重并发症，已成为西太平洋地区和中国的严重公共卫生问题之一。迄今为止，许多制药公司和研究机构已启动 EV71 疫苗的研究和开发，作为一种应对措施。与创新疫苗的开发一样，EV71 疫苗开发存在几个关键的瓶颈，在临床试验之前必须克服这些瓶颈，包括疫苗株的选择、中和抗体（NTAb）和抗原定量程序的标准化、参考标准和生物标准的建立和应用、用于评估保护效力的动物模型的开发，以及目标患者人群的确定。为了解决这些技术障碍，中国大陆的研究人员对疫苗株的筛选和标准、生物标准和检测方法的建立进行了一系列研究，从而推进了 EV71 疫苗的开发。本文综述了最近全球在 EV71 疫苗的质量控制和评估方面的进展。
