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

By: Nguyen L.C., Bakerlee C.W., McKelvey T.G., Rose S.M., Norman A.J., Joseph N., Manheim D., McLaren M.R., Jiang S., Barnes C.F., Kinniment M., Foster D., Darton T.C., Morrison J.
Published in: Clinical Infectious Diseases
SDGs : SDG 03  |  Units:   | Time: 2021 |  Link
Description: Human challenge trials (HCTs) have been proposed as a means to accelerate SARS-CoV-2 vaccine development. We identify an d 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 bemost 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 developmentshould 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. © 2020 The Author(s). Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.