人用狂犬病疫苗不同免疫程序临床试验设计要点的考虑  

Consideration of clinical trial design for human rabies vaccines with different immunization schedules

作　　者：邓霞 刘波 高晨燕 Deng Xia;Liu Bo;Gao Chenyan(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中华微生物学和免疫学杂志》2021年第12期974-978,共5页Chinese Journal of Microbiology and Immunology

摘　　要：本文参考疫苗临床试验相关指导原则和人用狂犬病疫苗研发及审评经验积累,同时结合世界卫生组织(World Health Organization,WHO)等主要卫生机构关于人用狂犬病疫苗使用的技术推荐,探讨了人用狂犬病疫苗临床试验设计中重点考虑的问题,包括对照疫苗的选择、有效性终点的设计和评价、受试人群的选择、样本量的估算、免疫持久性和再次暴露免疫程序的研究、上市后研究等,为开展人用狂犬病疫苗临床试验提供借鉴和参考。This article referred to the relevant guidelines for vaccine clinical trials and the accumulated experience in the development and review of human rabies vaccines,as well as combined the technical recommendations for human rabies vaccines from major health facilities such as WHO,to discuss the key considerations in the design of clinical trials for human rabies vaccines,including control vaccines,evaluation of efficacy endpoints,clinical subjects,the sample size,immunity persistence,re-exposure immunization schedule and post-marketing study.This article aimed to provide reference for the design of human rabies vaccine clinical trials.

关 键 词：人用狂犬病疫苗 免疫程序 临床试验 

分 类 号：R392[医药卫生—免疫学]