Human challenge trial (HCT) is a test in which human volunteers are intentionally infected with pathogens in order to evaluate the efficacy of candidate preventive or therapeutic drugs. During the COVID-19 pandemic, the HCT of vaccines has aroused people's attention due to its significant advantages over clinical trial. This paper introduces the concept, development and application of HCT, the advantages and limitations of HCT for vaccine evaluation, and the consideration of future HCT of COVID-19 vaccine in China.
人体挑战试验是指让人类志愿者有意感染病原体的试验，作为测试候选预防或治疗药物效果的方法。在新型冠状病毒肺炎（COVID-19）大流行期间，疫苗人体挑战试验因其较临床试验显著的优势而引起人们的关注。本文介绍了人体挑战试验的概念、发展、应用，人体挑战试验进行疫苗评估的优势和局限性，以及在中国未来开展新型冠状病毒疫苗人体挑战试验的考虑。.