Coronavirus Human Infection Challenge Studies: Assessing Potential Benefits and Risks

Area of Science:

• Infectious Diseases
• Vaccinology
• Bioethics

Background:

• Human infection challenge studies (HCS) are proposed to expedite SARS-CoV-2 vaccine development.
• Ethical acceptability of SARS-CoV-2 HCS hinges on a favorable risk-benefit balance.
• Systematic risk-benefit assessments are crucial for public trust in research and vaccines.

Purpose of the Study:

• To explore considerations for systematic risk-benefit assessments of SARS-CoV-2 HCS.
• To detail potential benefits of SARS-CoV-2 HCS, including accelerated vaccine development.
• To identify the need for modeling in ethical evaluations of HCS.

Main Methods:

• Review of ethical considerations for human infection challenge studies.
• Identification of key benefits associated with SARS-CoV-2 HCS.
• Exploration of modeling applications for risk-benefit analysis in HCS.

Main Results:

• Potential benefits of SARS-CoV-2 HCS, particularly in accelerating vaccine development, are detailed.
• Modeling is identified as essential for comparing HCS with field trials and estimating participant risks.
• Interactions between public health policy and research priorities are highlighted.

Conclusions:

• Systematic risk-benefit assessments are vital for the ethical conduct of SARS-CoV-2 HCS.
• Modeling can enhance ethical evaluations by comparing study types and quantifying risks.
• Balancing competing ethical considerations is necessary for research ethics review.