2021 review

Evaluating Use Cases for Human Challenge Trials in Accelerating SARS-CoV-2 Vaccine Development

[Review of ]. CLINICAL INFECTIOUS DISEASES, 72(4), 710–715.

By: L. Nguyen*, C. Bakerlee*, T. McKelvey, S. Rose*, A. Norman, N. Joseph*, D. Manheim*, M. McLaren n ...

co-author countries: Canada 🇨🇦 United Kingdom of Great Britain and Northern Ireland 🇬🇧 Israel 🇮🇱 United States of America 🇺🇸
author keywords: vaccine evaluation; COVID-19; pandemic; controlled human infection; human challenge trial
MeSH headings : COVID-19; COVID-19 Vaccines; Clinical Trials as Topic; Humans; Pandemics; SARS-CoV-2
Source: Web Of Science
Added: June 10, 2021

Human challenge trials (HCTs) have been proposed as a means to accelerate SARS-CoV-2 vaccine development. We identify and discuss 3 potential use cases of HCTs in the current pandemic: evaluating efficacy, converging on correlates of protection, and improving understanding of pathogenesis and the human immune response. We outline the limitations of HCTs and find that HCTs are likely to be most useful for vaccine candidates currently in preclinical stages of development. We conclude that, while currently limited in their application, there are scenarios in which HCTs would be extremely beneficial. Therefore, the option of conducting HCTs to accelerate SARS-CoV-2 vaccine development should be preserved. As HCTs require many months of preparation, we recommend an immediate effort to (1) establish guidelines for HCTs for COVID-19; (2) take the first steps toward HCTs, including preparing challenge virus and making preliminary logistical arrangements; and (3) commit to periodically re-evaluating the utility of HCTs.