Human challenge studies to accelerate coronavirus vaccine licensure.
Identifieur interne : 000584 ( Main/Exploration ); précédent : 000583; suivant : 000585Human challenge studies to accelerate coronavirus vaccine licensure.
Auteurs : Nir Eyal [États-Unis] ; Marc Lipsitch [États-Unis] ; Peter G. Smith [Royaume-Uni]Source :
- The Journal of infectious diseases [ 1537-6613 ] ; 2020.
Abstract
Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional Phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly. Obviously, challenging volunteers with this live virus risks inducing severe disease and possibly even death. However, we argue that such studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity. Volunteers in such studies could autonomously authorize the risks to themselves, and their net risk could be acceptable if participants comprise healthy young adults, who are at relatively low risk of serious disease following natural infection, they have a high baseline risk of natural infection, and during the trial they receive frequent monitoring and, following any infection, the best available care.
DOI: 10.1093/infdis/jiaa152
PubMed: 32232474
Affiliations:
- Royaume-Uni, États-Unis
- Angleterre, Grand Londres, Massachusetts, New Jersey
- Londres, New Brunswick (New Jersey)
- Université Rutgers
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<front><div type="abstract" xml:lang="en">Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional Phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly. Obviously, challenging volunteers with this live virus risks inducing severe disease and possibly even death. However, we argue that such studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity. Volunteers in such studies could autonomously authorize the risks to themselves, and their net risk could be acceptable if participants comprise healthy young adults, who are at relatively low risk of serious disease following natural infection, they have a high baseline risk of natural infection, and during the trial they receive frequent monitoring and, following any infection, the best available care.</div>
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