Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure
Open Access
- 31 March 2020
- journal article
- research article
- Published by Oxford University Press (OUP) in The Journal of Infectious Diseases
- Vol. 221 (11), 1752-1756
- https://doi.org/10.1093/infdis/jiaa152
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.Keywords
Funding Information
- National Institute of Allergy and Infectious Diseases (AI114617-01A1)
- National Institute of General Medical Sciences (U54GM088558)
- Morris-Singer Foundation
- Department of Health and Social Care
- Medical Research Council
- Department for International Development
- European Commission
This publication has 9 references indexed in Scilit:
- Characteristics of pediatric SARS-CoV-2 infection and potential evidence for persistent fecal viral sheddingNature Medicine, 2020
- [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China].2020
- Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus EntryJournal of Virology, 2020
- The Epidemiological Characteristics of an Outbreak of 2019 Novel Coronavirus Diseases (COVID-19) — China, 2020China CDC Weekly, 2020
- Risk to Nonparticipants in HIV Remission Studies With Treatment Interruption: A SymposiumThe Journal of Infectious Diseases, 2019
- The Future of Flu: A Review of the Human Challenge Model and Systems Biology for Advancement of Influenza VaccinologyFrontiers in Cellular and Infection Microbiology, 2019
- Ethical issues in HIV remission trialsCurrent Opinion in HIV and AIDS, 2018
- The Ethical Challenges of Human ResearchPublished by Oxford University Press (OUP) ,2012