The following articles cover important research around controlled human infection studies and COVID-19.
- Shah et al. describe an ethical framework for controlled human infection (CHI) studies for SARS-CoV-2 vaccines. They outline ethical conditions for conducting CHIs, including whether the potential social value justifies the risk, and provide guidance for various research stakeholders who are considering CHIs.
- Eyal et al. write in the Journal of Infectious Diseases that CHI trials could speed testing and rollout of an efficacious SARS-CoV-2 vaccine by several months and the net risk could be acceptable if certain conditions are met.
- The World Health Organization offers guidance to various research stakeholders on CHI studies by outlining necessary study criteria to ensure CHI’s for SARS-CoV-2 vaccines are ethically acceptable.
- AVAC and TAG released a statement in response to the WHO guidelines that argue ethical CHI studies may not be possible in the absence of well-understood pathogenesis and approved treatment. They call for a standing committee of research stakeholders, including community representatives, to address the ethics of SARS-CoV-2 challenge trials and review protocols.
- STAT News points out the myriad issues involved in CHI studies, including observations that the time needed to develop the challenge model may negate anticipated acceleration.
- The outcome of a pre-COVID Welcome Trust sponsored meeting on controlled human infection studies offers a framework for considering benefits and barriers to the conduct of CHI studies in low and middle income country settings.