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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。
In view of the safety of live attenuated vaccines, most national drug regulatory regulations require the study of neurotoxicity in monkeys when attenuated vaccine strains are isolated from wild-type CNS-targeted strains To evaluate the safety of attenuated vaccine strains. However, there are differences between different laws and regulations on the test of neurotoxicity in monkeys and not applicable to some attenuated live attenuated vaccines. Before carrying out the test of neurotoxicity in monkeys, we should consider the clinical characteristics of wild-type strains, the clinical experience of vaccines already in the market, the in vitro evaluation of vaccines and in vivo test results to determine whether it is necessary to conduct a study on the neurotoxicity of monkeys . This article reviews the problems existing in the neurotoxicity test of monkeys and their alternatives and their applications in the safety assessment of live attenuated vaccines.