摘要
人体挑战试验(Human challenge trial,HCT)是用致病性菌株故意感染人类受试者的一类试验。作为一种加速疫苗研发的研究方法,HCT的主要作用包括阐明致病机理和免疫机制、评价疫苗效力、筛选候选疫苗、加快疫苗审批许可等。本文介绍了HCT的概念、开展HCT需考虑的因素和试验步骤、HCT的既往应用以及开展新型冠状病毒疫苗HCT的考虑。
Human challenge trials(HCTs) involve deliberate exposure of volunteers to pathogens. As an approach to accelerate vaccine development, HCTs aim to clarify pathogenic and immunologic mechanisms, evaluate efficacy of vaccine candidates, select candidate vaccines for further development, and ultimately shorten time required for vaccine approval. In this article, we describe HCT concepts, considerations and procedures for HCT implementation, previous applications of HCTs, and considerations for SARS-CoV-2 vaccine HCTs.
作者
胡倩倩
张倩
李媛秋
郑徽
王富珍
尹遵栋
Hu Qianqian;Zhang Qian;Li Yuanqiu;Zheng Hui;Wang Fuzhen;Yin Zundong(National Immunization Program,Chinese Center for Disease Control and Prevention,Beijing 100050,China)
出处
《中国疫苗和免疫》
CSCD
北大核心
2021年第2期221-225,共5页
Chinese Journal of Vaccines and Immunization
基金
国家科技重大专项“疫苗临床评价技术平台建设”课题(2018ZX09734004)。
