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Third human challenge trial conference, Oxford, United Kingdom, February 6-7, 2020, a meeting report.
Biologicals ( IF 1.7 ) Pub Date : 2020-06-04 , DOI: 10.1016/j.biologicals.2020.04.004
Andrew J Pollard 1 , Robert Sauerwein 2 , Marc Baay 3 , Pieter Neels 4 ,
Affiliation  

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.



中文翻译:

2020年2月6日至7日在英国牛津举行的第三次人类挑战试验会议,会议报告。

第三届人类挑战试验会议召集了包括学术界,监管机构,出资者和工业界在内的广泛的国际利益相关者,来自中低收入国家的代表团也参加了此次会议。

受控人类感染模型(CHIM)有助于研究发病机理和开发疫苗。由于使用了挑战剂来感染健康的志愿者,因此从伦理上考虑,挑战研究必须是安全的,结果应有意义。会议提供了有关各种CHIM(包括病毒,细菌和寄生虫激发剂)的最新技术概述。建议包括针对CHIM研究的全球统一指导文件;根据使用的挑战剂,进一步定义CHIM;方法学和研究终点的标准化;低收入和中等收入国家的能力建设,CHIM研究的绩效和监管;参与CHIM研究的补偿指南;并与利益相关者密切合作,准备CHIM研究。

更新日期:2020-06-04
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