Journal
CLINICAL INFECTIOUS DISEASES
Volume 73, Issue 5, Pages E1228-E1234Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciaa1784
Keywords
COVID-19; SARS-CoV-2; controlled human infection model; human challenge model; risk assessment
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Controlled human infection models for SARS-CoV-2 have been proposed to expedite the development of vaccines and drugs, but come with inherent risks that must be carefully evaluated and mitigated to minimize negative impacts on participants and the community.
Controlled human infection (CHI) models for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been proposed as a tool to accelerate the development of vaccines and drugs. Such models carry inherent risks. Participants may develop severe disease or complications after deliberate infection. Prolonged isolation may negatively impact their well-being. Through secondary infection of study personnel or participant household contacts, the experimental virus strain may cause a community outbreak. We identified risks associated with such a SARS-CoV-2 CHI model and assessed their likelihood and impact and propose strategies that mitigate these risks. In this report, we show that risks can be minimized with proper risk mitigation strategies; the residual risk, however, should be weighed carefully against the scientific and social values of such a CHI model.
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