Abstract：
The traditional regulatory pathway for the evaluation of new vaccine candidates generally proceeds from preclinical through three successive phases of human trials, and the demonstration of efficacy is usually done through randomized-controlled clinical trials. However, human challenge trials or controlled human infection models have been used in vaccine clinical development to generate supportive data for establishment of correlates of protection, supportive data for licensure, as well as licensure in the case of Vaxchora® by the US FDA. Despite this, there are no codified regulations from national regulatory authorities (NRAs) that specifically address HCTs, nor guidance related to standardization of approaches to HCTs among regulators. NRAs may agree that HCTs are innovative, promising tools to accelerate vaccine development; however, a strong benefit/risk assessment is needed to ensure the safety of study participants. Lastly, it is important to consider the regulatory framework in which the human challenge trial may be conducted.
摘要：
评估新候选疫苗的传统调节途径通常从临床前开始，经过三个连续的人体试验阶段，疗效的证明通常是通过随机对照临床试验完成的。然而,人类攻击试验或受控人类感染模型已用于疫苗临床开发，以产生支持性数据，以建立相关的保护，许可的支持性数据，以及美国FDA对Vaxchora®的许可。尽管如此,没有来自国家监管机构(NRA)的专门针对HCT的成文法规，也不是与监管机构之间HCT方法标准化相关的指导。NRA可能会同意HCT是创新的，加速疫苗开发的有希望的工具；然而，需要进行强有力的获益/风险评估,以确保研究参与者的安全.最后,重要的是要考虑进行人类挑战试验的监管框架。
