人体挑战试验在疫苗临床评价中的应用  

Use of human challenge trials in vaccine clinical evaluation

作　　者：胡文婧 金来润 王家琪 曹祥 朱凤才[1,2] 李靖欣 Hu Wenjing;Jin Lairun;Wang Jiaqi;Cao Xiang;Zhu Fengcai;Li Jingxin(School of Public Health,Southeast University,Nanjing 210009,Jiangsu,China;Jiangsu Provincial Medical Innovation Center,National Health Commission Key Laboratory of Enteric Pathogenic Microbiology,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,Jiangsu,China;Department of Vaccine Clinical Evaluation,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,Jiangsu,China)

机构地区：[1]东南大学公共卫生学院,江苏南京210009 [2]江苏省疾病预防控制中心国家卫生健康委员会肠道病原微生物重点实验室,江苏省医学创新中心,江苏南京210009 [3]江苏省疾病预防控制中心疫苗临床评价所,江苏南京210009

出　　处：《中国疫苗和免疫》2024年第1期87-94,共8页Chinese Journal of Vaccines and Immunization

基　　金：国家自然科学基金(82222062);江苏省杰出青年科学基金(BK20220064);江苏省重点研发计划(BE2021738)。

摘　　要：人体挑战试验(Human challenge trial,HCT)是旨在通过志愿者主动感染病原体以全面了解特定传染病的发病机制、传播、预防和治疗的一种研究方法,可应用于疫苗的临床评价,有利于加速疫苗研发。HCT在一些国家已应用于疟疾疫苗、流感疫苗、霍乱疫苗等临床评价中,中国尚无相关政策支持开展HCT。本文综述了在疫苗临床评价中HCT的开展条件、应用、优缺点和伦理问题,探讨HCT在疫苗临床评价中的应用价值和前景。A human challenge trial(HCT)is a research method to comprehensively explore the pathogenesis,transmission,prevention,and treatment of specific infectious diseases by deliberately infecting volunteers with pathogens.Such trials can be used for vaccine clinical evaluation and can help accelerate vaccine development.HCTs have been used in clinical evaluations of many vaccines,including malaria,influenza,and cholera vaccines in some countries;in China,there are no relevant policies supporting the conduct of HCTs.In this article,we describe conditions,applications,advantages/disadvantages,and ethical issues of conducting HCTs for vaccine clinical evaluation and discuss the value and prospects of HCT use in vaccine clinical evaluation.

关 键 词：人体挑战试验 疫苗 临床评价 伦理 

分 类 号：R181[医药卫生—流行病学]