摘要
手足口病(Hand foot and mouth disease,HFMD)已成为西太平洋区严重的公共卫生问题之一,肠道病毒71型(Enterovirus 71,EV71)是引起HFMD的主要病原体,研发疫苗是控制HFMD流行的有效手段。目前世界范围已有5个EV71全病毒灭活疫苗进入临床试验,其中中国研制的3种EV71疫苗已分别完成III期临床试验,结果表明3种疫苗都具有良好的安全性和保护效果。在EV71疫苗研发中,抗原质控的方法和标准是研发的瓶颈,其中抗原活性测定是工序工艺优化、免疫原性评价和剂量确定的关键指标。综述了EV71疫苗抗原质控的研究进展。
Hand foot and mouth disease （ HFMD） has become the serious public health problem in Asia-Pacific region, and enterovirus 71 （EV71） was the major causative agent for HFMD.The development of EV71 vaccine was the effective method for controlling HFMD.The inactivated EV71 whole-virus vaccines from five manufacturers entered clinical trials in the world.The vaccines from three manufacturers in China have been completed the phase III clinical trials.Clinical results indicated that these vaccines have a high efficacy, satisfactory safety, and sustained immunogenicity.However, it is a gap to establish the quality control of antigen content and standard in development of a vaccine.The detection of antigen content is the crucial item for optimization in production process, evaluation of immunogenicity and dose selection.This article summarized the progress on quality control of EV71 antigen.
出处
《微生物学免疫学进展》
2015年第5期69-72,共4页
Progress In Microbiology and Immunology
基金
国家"十二五"科技重大专项课题(2012ZX10004701)
