Department of Paediatrics, University of Oxford, United Kingdom.
Radboud University Medical Center, the Netherlands.
Biologicals. 2020 Jul;66:41-52. doi: 10.1016/j.biologicals.2020.04.004. Epub 2020 Jun 4.
The third Human Challenge Trial Meeting brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable delegation from Low- and Middle-Income Countries. Controlled human infection models (CHIMs) can be helpful to study pathogenesis and for the development of vaccines. As challenge agents are used to infect healthy volunteers, ethical considerations include that the challenge studies need to be safe and results should be meaningful. The meeting provided a state-of-the-art overview on a wide range of CHIMs, including viral, bacterial and parasitic challenge agents. Recommendations included globally aligned guidance documents for CHIM studies; further definition of a CHIM, based on the challenge agent used; standardization of methodology and study endpoints; capacity building in Low- and Middle-Income Countries, in performance as well as regulation of CHIM studies; guidance on compensation for participation in CHIM studies; and preparation of CHIM studies, with strong engagement with stakeholders.
第三届人类挑战试验会议汇聚了广泛的国际利益相关者，包括学术界、监管机构、资助者和行业，其中有相当数量的来自中低收入国家的代表。人体感染控制模型（CHIM）有助于研究发病机制和疫苗开发。由于挑战剂被用于感染健康志愿者，因此需要考虑到伦理问题，即挑战研究必须安全，并且结果应该有意义。会议全面介绍了广泛的 CHIM，包括病毒、细菌和寄生虫挑战剂。建议包括为 CHIM 研究制定全球一致的指导文件；根据使用的挑战剂进一步定义 CHIM；标准化方法和研究终点；在中低收入国家进行能力建设，包括 CHIM 研究的实施和监管；关于参与 CHIM 研究的补偿的指导；以及 CHIM 研究的准备，与利益相关者密切合作。
