Issue 7: Must Read Scientific Articles

May 13, 2020

By Ted Schenkelberg, M.B.A., M.P.H.

Chief Operating Officer

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.

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