Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials.

Asymptomatic Infections COVID-19 / diagnosis COVID-19 Testing COVID-19 Vaccines / adverse effects Clinical Trials, Phase III as Topic / methods Humans Randomized Controlled Trials as Topic / methods SARS-CoV-2 Severity of Illness Index

Journal

Annals of internal medicine
ISSN: 1539-3704
Titre abrégé: Ann Intern Med
Pays: United States
ID NLM: 0372351

Informations de publication

Date de publication:
02 2021
Historique:
pubmed: 23 10 2020
medline: 25 2 2021
entrez: 22 10 2020
Statut: ppublish

Résumé

Several vaccine candidates to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or coronavirus disease 2019 (COVID-19) have entered or will soon enter large-scale, phase 3, placebo-controlled randomized clinical trials. To facilitate harmonized evaluation and comparison of the efficacy of these vaccines, a general set of clinical endpoints is proposed, along with considerations to guide the selection of the primary endpoints on the basis of clinical and statistical reasoning. The plausibility that vaccine protection against symptomatic COVID-19 could be accompanied by a shift toward more SARS-CoV-2 infections that are asymptomatic is highlighted, as well as the potential implications of such a shift.

Identifiants

DOI: 10.7326/M20-6169 PMID: 33090877 PMC: PMC7596738
pubmed: 33090877
doi: 10.7326/M20-6169
pmc: PMC7596738
doi:

Substances chimiques

COVID-19 Vaccines 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

221-228

Subventions

Organisme : NIAID NIH HHS
ID : R37 AI029168
Pays : United States
Organisme : NIAID NIH HHS
ID : R01 AI029168
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068614
Pays : United States
Organisme : NIAID NIH HHS
ID : R37 AI054165
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068635
Pays : United States

Auteurs

Devan V Mehrotra (DV)

Biostatistics and Research Decision Sciences, Merck & Co., North Wales, Pennsylvania (D.V.M., J.H.).
ORCID: 0000-0002-0316-7362

Holly E Janes (HE)

Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., D.D., Y.F., Y.H., Y.H., O.H., M.J.).

Thomas R Fleming (TR)

Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington (T.R.F., E.R.B., M.C., L.C., P.B.G.).

Paula W Annunziato (PW)

Vaccines Clinical Research, Merck & Co., Kenilworth, New Jersey (P.W.A.).
ORCID: 0000-0002-5387-0216

Kathleen M Neuzil (KM)

University of Maryland School of Medicine, Baltimore, Maryland (K.M.N.).

Lindsay N Carpp (LN)

Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., D.D., Y.F., Y.H., Y.H., O.H., M.J.).
ORCID: 0000-0003-0333-5925

David Benkeser (D)

Rollins School of Public Health, Emory University, Atlanta, Georgia (D.B.).
ORCID: 0000-0002-1019-8343

Elizabeth R Brown (ER)

Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington (T.R.F., E.R.B., M.C., L.C., P.B.G.).
ORCID: 0000-0003-4286-2111

Marco Carone (M)

Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington (T.R.F., E.R.B., M.C., L.C., P.B.G.).

Iksung Cho (I)

Novavax, Gaithersburg, Maryland (I.C.).

Deborah Donnell (D)

Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., D.D., Y.F., Y.H., Y.H., O.H., M.J.).
ORCID: 0000-0002-0587-7480

Michael P Fay (MP)

National Institute of Allergy and Infectious Diseases, Bethesda, Maryland (M.P.F., M.N., D.F.).
ORCID: 0000-0002-8643-9625

Youyi Fong (Y)

Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., D.D., Y.F., Y.H., Y.H., O.H., M.J.).

Shu Han (S)

Moderna, Cambridge, Massachusetts (S.H., H.Z.).

Ian Hirsch (I)

AstraZeneca, Cambridge, United Kingdom (I.H.).
ORCID: 0000-0003-1232-9770

Ying Huang (Y)

Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., D.D., Y.F., Y.H., Y.H., O.H., M.J.).
ORCID: 0000-0002-9655-7502

Yunda Huang (Y)

Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., D.D., Y.F., Y.H., Y.H., O.H., M.J.).
ORCID: 0000-0003-1546-6172

Ollivier Hyrien (O)

Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., D.D., Y.F., Y.H., Y.H., O.H., M.J.).

Michal Juraska (M)

Fred Hutchinson Cancer Research Center, Seattle, Washington (H.E.J., L.N.C., D.D., Y.F., Y.H., Y.H., O.H., M.J.).
ORCID: 0000-0002-0920-2915

Alex Luedtke (A)

University of Washington, Seattle, Washington (A.L.).
ORCID: 0000-0002-9936-3236

Martha Nason (M)

National Institute of Allergy and Infectious Diseases, Bethesda, Maryland (M.P.F., M.N., D.F.).
ORCID: 0000-0002-0110-881X

An Vandebosch (A)

Janssen Pharmaceuticals, Beerse, Belgium (A.V.).

Honghong Zhou (H)

Moderna, Cambridge, Massachusetts (S.H., H.Z.).

Myron S Cohen (MS)

Institute for Global Health and Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina (M.S.C.).

Lawrence Corey (L)

Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington (T.R.F., E.R.B., M.C., L.C., P.B.G.).
ORCID: 0000-0002-2179-2436

Jonathan Hartzel (J)

Biostatistics and Research Decision Sciences, Merck & Co., North Wales, Pennsylvania (D.V.M., J.H.).

Dean Follmann (D)

National Institute of Allergy and Infectious Diseases, Bethesda, Maryland (M.P.F., M.N., D.F.).
ORCID: 0000-0003-4073-0393

Peter B Gilbert (PB)

Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington (T.R.F., E.R.B., M.C., L.C., P.B.G.).
ORCID: 0000-0002-2662-9427

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Classifications MeSH

questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Caractéristiques de la maladie › Maladies asymptomatiques › Infections asymptomatiques › Clinical Endpoints for Evaluating Efficacy in...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Pneumopathie infectieuse › Pneumopathie virale › COVID-19 › Clinical Endpoints for Evaluating Efficacy in...
questionsmedicales.fr › Techniques d'investigation › Techniques de laboratoire clinique › Dépistage de la COVID-19 › Clinical Endpoints for Evaluating Efficacy in...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins antiviraux › Vaccins contre la COVID-19 › Clinical Endpoints for Evaluating Efficacy in...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques de phase III comme sujet › Clinical Endpoints for Evaluating Efficacy in...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Clinical Endpoints for Evaluating Efficacy in...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Clinical Endpoints for Evaluating Efficacy in...
questionsmedicales.fr › Virus › Virus à ARN › Virus à ARN à brin positif › Nidovirales › Coronaviridae › Coronavirus › Betacoronavirus › Virus du SRAS › SARS-CoV-2 › Clinical Endpoints for Evaluating Efficacy in...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Enquêtes de santé › Indicateurs d'état de santé › Acuité des besoins du patient › Indice de gravité de la maladie › Clinical Endpoints for Evaluating Efficacy in...