人呼吸道合胞病毒疫苗临床研发与评价  

Clinical development and evaluation of human respiratory syncytial virus vaccines

作　　者：陈艳 王海学 CHEN Yan;WANG Hai-xue(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,北京100076

出　　处：《中国新药杂志》2025年第1期43-51,共9页Chinese Journal of New Drugs

摘　　要：人呼吸道合胞病毒(human respiratory syncytial virus, RSV)是常见的呼吸道病毒,在全球广泛流行。RSV可感染各年龄段人群,但主要集中在儿童、老年人和免疫功能低下者等高危人群,给5岁以下儿童和老年人群带来较重的疾病负担。疫苗是预防RSV感染、传播、导致重症的重要手段之一,世界卫生组织将RSV疫苗列为全球最优先研发的疫苗之一。目前国外已有3款RSV疫苗获批上市,国内已有多个进口RSV疫苗获得临床试验许可,但尚无RSV疫苗获批上市。本文梳理了国外已上市RSV疫苗确证性临床试验评价的关键要点以及RSV疫苗临床研发技术指南,结合国内相关工作基础和技术文献,分析和讨论了此类疫苗在国内临床研发的可行性及可借鉴的经验,供研发企业和临床研究者参考。Human respiratory syncytial virus(RSV)is a common respiratory virus that is widely prevalent worldwide.RSV can infect people of all ages,but it is mainly concentrated in high-risk groups such as children,elderly,and immunocompromised individuals,bringing a heavy disease burden to children under 5 years old and the elderly population.Vaccines are one of the important means to prevent RSV infection,transmission,and progression of illness.The WHO has listed RSV vaccines as one of the world's top priority vaccines to research and develop.At present,three RSV vaccines have been approved for marketing abroad,and several imported RSV vaccines have obtained clinical trial licenses in China,but have not yet been approved for marketing.This article summarizes the key points of confirmatory clinical trials of RSV vaccines that have already been marketed,as well as the technical guidelines for clinical development of RSV vaccines abroad.Based on relevant domestic work foundations and technical literatures,the feasibility and reference experiences of such vaccines in clinical development in China are analyzed and discussed,providing references for sponsors and clinical researchers.

关 键 词：人呼吸道合胞病毒 疫苗 临床研发 指南 

分 类 号：R95[医药卫生—药学]