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.
Abstract
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.
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