猴体神经毒力试验在减毒活疫苗安全性评价中的应用  

Application of monkey neurovirulence test in safety assessment of live attenuated vaccines

作　　者：尹雅姝 谷业新 黄金凤 

机构地区：[1]科兴(大连)疫苗技术有限公司,辽宁大连116620

出　　处：《中国生物制品学杂志》2015年第7期760-764,共5页Chinese Journal of Biologicals

摘　　要：出于对减毒活疫苗的安全性考虑,当从具有中枢神经系统靶向性的野毒株中分离得到减毒疫苗株时,大多数国家的药品注册法规均要求开展猴体神经毒力研究,以评价减毒疫苗株的安全性。但猴体神经毒力试验存在不同法规间的差异、对个别减毒活疫苗不适用等问题。在开展猴体神经毒力试验前,应综合考虑野毒株的临床学特性、已上市疫苗的临床应用经验、疫苗的体外评价及体内试验结果,最终确定是否有必要开展猴体神经毒力研究。本文对猴体神经毒力试验存在的问题、替代方法及其在不同减毒活疫苗安全性评价中的应用作一综述。Taking account of the safety of live attenuated vaccines, monkey neurovirulence test is required for isolation of attenuated vaccine strains from the wild strains targeting central nervous system in regulations for registration of drugs in most countries. However, monkey neurovirulence tests are different in various regulations, and unsuitable for individual live attenuated vaccines. Therefore it is recommended that once monkey neurovirulence test will be conducted, the neces-sary should be fully assessed by considering the clinical characters of wild strain, the experience in clinical applications of commercial vaccines as well as the available results of some in vitro and in vivo tests. This paper reviews the problems of monkey neutrovirulence test, some replacement methods as well as their application in safety assessment of various live attenuated vaccines.

关 键 词：猴体神经毒力试验 减毒活疫苗 安全性评价 

分 类 号：Q939.93[生物学—微生物学] R392-33[医药卫生—免疫学]