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Nguyen LC, Bakerlee CW, McKelvey TG, et al. Evaluating Use Cases for Human Challenge Trials in Accelerating SARS-CoV-2 Vaccine Development. Clin Infect Dis. 2021;72(4):710-715doi: 10.1093/cid/ciaa935.
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. (2021). Evaluating Use Cases for Human Challenge Trials in Accelerating SARS-CoV-2 Vaccine Development. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 72(4), 710-715. https://doi.org/10.1093/cid/ciaa935
Nguyen, Linh Chi, et al. "Evaluating Use Cases for Human Challenge Trials in Accelerating SARS-CoV-2 Vaccine Development." Clinical infectious diseases : an official publication of the Infectious Diseases Society of America vol. 72,4 (2021): 710-715. doi: https://doi.org/10.1093/cid/ciaa935
Nguyen LC, Bakerlee CW, McKelvey TG, Rose SM, Norman AJ, Joseph N, Manheim D, McLaren MR, Jiang S, Barnes CF, Kinniment M, Foster D, Darton TC, Morrison J. Evaluating Use Cases for Human Challenge Trials in Accelerating SARS-CoV-2 Vaccine Development. Clin Infect Dis. 2021 Feb 16;72(4):710-715. doi: 10.1093/cid/ciaa935. PMID: 32628748; PMCID: PMC7454474.
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Clin Infect Dis. 2021 Feb 16;72(4):710-715. doi: 10.1093/cid/ciaa935.

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

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Linh Chi Nguyen, Christopher W Bakerlee, 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

Affiliations

  1. Department of Politics and International Relations, University of Oxford, Oxford, United Kingdom.
  2. Department of Molecular and Cellular Biology, Harvard University, Cambridge, Massachusetts, USA.
  3. Department of Organismic and Evolutionary Biology, Harvard University, Cambridge, Massachusetts, USA.
  4. ASAPP, Inc, NY, USA.
  5. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  6. Independent Scholar, Worthing, United Kingdom.
  7. Independent Scholar, Oakland, California, USA.
  8. Health and Risk Communication Research Center, School of Public Health, University of Haifa, Haifa, Israel.
  9. Department of Population Health and Pathobiology, North Carolina State University, Raleigh, North Carolina, USA.
  10. Harvard Law School, Cambridge, Massachusetts, USA.
  11. Independent Scholar, Kelowna, British Columbia, Canada.
  12. Department of Physics, University of Oxford, Oxford, United Kingdom.
  13. Rethink Priorities, Redwood City, California, USA.
  14. Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.
  15. Waitlist Zero, Brooklyn, New York, USA.

PMID: 32628748 PMCID: PMC7454474 DOI: 10.1093/cid/ciaa935

Abstract

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.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected].

Keywords: COVID-19; controlled human infection; human challenge trial; pandemic; vaccine evaluation

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