Testing SARS-CoV-2 vaccine efficacy through deliberate natural viral exposure.
Coronavirus
Ethics
Human challenge studies
Randomized controlled trials
Research design
Vaccines
Journal
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
ISSN: 1469-0691
Titre abrégé: Clin Microbiol Infect
Pays: England
ID NLM: 9516420
Informations de publication
Date de publication:
Mar 2021
Mar 2021
Historique:
received:
07
10
2020
revised:
19
12
2020
accepted:
24
12
2020
pubmed:
10
1
2021
medline:
12
3
2021
entrez:
9
1
2021
Statut:
ppublish
Résumé
A vaccine trial with a conventional challenge design can be very fast once it starts, but it requires a long prior process, in part to grow and standardize challenge virus in the laboratory. This detracts somewhat from its overall promise for accelerated efficacy testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine candidates, and from the ability of developing countries and small companies to conduct it. We set out to identify a challenge design that avoids this part of the long prior process. Literature in trial design (including a proof of concept flu challenge trial by B. Killingley et al.), vaccinology, medical ethics, and various aspects of COVID response. A challenge design with deliberate natural viral exposure avoids the need to grow culture. This new design is described and compared both to a conventional challenge design and to a conventional phase III field trial. In comparison, the proposed design has ethical, scientific, and feasibility strengths. The proposed new design should be considered for future vaccine trials.
Sections du résumé
BACKGROUND
BACKGROUND
A vaccine trial with a conventional challenge design can be very fast once it starts, but it requires a long prior process, in part to grow and standardize challenge virus in the laboratory. This detracts somewhat from its overall promise for accelerated efficacy testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine candidates, and from the ability of developing countries and small companies to conduct it.
AIMS
OBJECTIVE
We set out to identify a challenge design that avoids this part of the long prior process.
SOURCES
METHODS
Literature in trial design (including a proof of concept flu challenge trial by B. Killingley et al.), vaccinology, medical ethics, and various aspects of COVID response.
CONTENT
BACKGROUND
A challenge design with deliberate natural viral exposure avoids the need to grow culture. This new design is described and compared both to a conventional challenge design and to a conventional phase III field trial. In comparison, the proposed design has ethical, scientific, and feasibility strengths.
IMPLICATIONS
CONCLUSIONS
The proposed new design should be considered for future vaccine trials.
Identifiants
pubmed: 33421580
pii: S1198-743X(20)30792-8
doi: 10.1016/j.cmi.2020.12.032
pmc: PMC7787506
pii:
doi:
Substances chimiques
COVID-19 Vaccines
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
372-377Informations de copyright
Copyright © 2021 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
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