Nguyen, L.C., Bakerlee, C.W., McKelvey, T.G. et al. (11 more authors) (2021) Evaluating use cases for human challenge trials in accelerating SARS-CoV-2 vaccine development. Clinical Infectious Diseases, 72 (4). pp. 710-715. ISSN 1058-4838
Abstract
Human challenge trials (HCTs) have been proposed as a means to accelerate SARS-CoV-2 vaccine development. We identify and discuss three 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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. This is an author-produced version of a paper subsequently published in Clinical Infectious Diseases. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | Vaccine evaluation; COVID-19; Pandemic; Controlled Human Infection; Human Challenge Trial |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Sheffield Teaching Hospitals |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 10 Jul 2020 16:17 |
Last Modified: | 20 Jan 2022 11:04 |
Status: | Published |
Publisher: | Oxford University Press (OUP) |
Refereed: | Yes |
Identification Number: | 10.1093/cid/ciaa935 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:163143 |