The Ethics of Human Challenge Trials Using Emerging Severe Acute Respiratory Syndrome 2 Variants

J Infect Dis. 2022 Mar 15;225(6):934-937. doi: 10.1093/infdis/jiab488.

Abstract

The world's first coronavirus disease 2019 human challenge trial using the D614G strain of severe acute respiratory syndrome 2 (SARS-CoV-2) is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta and Delta variant for a follow-up human challenge trial, and researchers at hVIVO are considering conducting these trials. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern. We explore 2 specific characteristics of some variants that may initially be thought to make such trials unethical and conclude that SARS-CoV-2 variant challenge trials can remain ethical.

Keywords: COVID-19; controlled human infection model; human challenge trials; research ethics; vaccine ethics.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • COVID-19 / prevention & control*
  • COVID-19 Vaccines / administration & dosage*
  • COVID-19 Vaccines / adverse effects
  • COVID-19 Vaccines / immunology
  • Ethics
  • Ethics, Research*
  • Humans
  • SARS-CoV-2 / genetics*
  • United Kingdom
  • Vaccines

Substances

  • COVID-19 Vaccines
  • Vaccines

Supplementary concepts

  • SARS-CoV-2 variants