Evaluating use cases for human challenge trials in accelerating COVID-19 vaccine development

• DOI: 10.31219/osf.io/7gc4b
• Publication Date: 2020-05-14T11:50:01Z
• Authors: Linh Chi Nguyen; Christopher W Bak...; T Greg McKelvey; Sophie M Rose; Alexander J Norman; Nicholas Joseph; David Manheim; Michael R McLaren; Steven Jiang; Conor F Barnes; Megan Kinniment; Derek Foster; Thomas C Darton; Josh Morrison
• Keywords: Commit; Pandemic; 2019-20 coronavirus outbreak

Recently, human challenge trials (HCTs) have been proposed as a means to accelerate the development of an effective SARS-CoV-2 vaccine. In this paper, we discuss potential role for such studies in current COVID-19 pandemic. First, present three scenarios which HCTs could be useful: evaluating efficacy, converging on correlates protection, and improving understanding pathogenesis immune response. We go outline practical limitations these scenarios. conclude that, while currently limited their application, there are would vastly beneficial and, thus, option using vaccine should preserved. To end, recommend immediate, coordinated effort by all stakeholders (1) establish ethical guidelines use COVID-19; (2) take first steps toward HCT, including preparing virus under GMP making preliminary logistical arrangements; (3) commit periodically re-evaluating utility amid evolving