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Evaluating Use Cases for Human Challenge Trials in Accelerating SARS-CoV-2 Vaccine Development.
Nguyen, Linh Chi; Bakerlee, Christopher W; McKelvey, T Greg; Rose, Sophie M; Norman, Alexander J; Joseph, Nicholas; Manheim, David; McLaren, Michael R; Jiang, Steven; Barnes, Conor F; Kinniment, Megan; Foster, Derek; Darton, Thomas C; Morrison, Josh.
  • Nguyen LC; Department of Politics and International Relations, University of Oxford, Oxford, United Kingdom.
  • Bakerlee CW; Department of Molecular and Cellular Biology, Harvard University, Cambridge, Massachusetts, USA.
  • McKelvey TG; Department of Organismic and Evolutionary Biology, Harvard University, Cambridge, Massachusetts, USA.
  • Rose SM; ASAPP, Inc, NY, USA.
  • Norman AJ; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
  • Joseph N; Independent Scholar, Worthing, United Kingdom.
  • Manheim D; Independent Scholar, Oakland, California, USA.
  • McLaren MR; Health and Risk Communication Research Center, School of Public Health, University of Haifa, Haifa, Israel.
  • Jiang S; Department of Population Health and Pathobiology, North Carolina State University, Raleigh, North Carolina, USA.
  • Barnes CF; Harvard Law School, Cambridge, Massachusetts, USA.
  • Kinniment M; Independent Scholar, Kelowna, British Columbia, Canada.
  • Foster D; Department of Physics, University of Oxford, Oxford, United Kingdom.
  • Darton TC; Rethink Priorities, Redwood City, California, USA.
  • Morrison J; Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.
Clin Infect Dis ; 72(4): 710-715, 2021 02 16.
Article in English | MEDLINE | ID: covidwho-634179
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: Cid

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: Cid