Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure.
J Infect Dis
; 221(11): 1752-1756, 2020 05 11.
Article
en En
| MEDLINE
| ID: mdl-32232474
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, if they have a high baseline risk of natural infection, and if during the trial they receive frequent monitoring and, following any infection, the best available care.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Neumonía Viral
/
Vacunas Virales
/
Ensayos Clínicos como Asunto
/
Infecciones por Coronavirus
/
Pandemias
/
Desarrollo de Medicamentos
Tipo de estudio:
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
J Infect Dis
Año:
2020
Tipo del documento:
Article
País de afiliación:
Estados Unidos