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Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials.
Mehrotra, Devan V; Janes, Holly E; Fleming, Thomas R; Annunziato, Paula W; Neuzil, Kathleen M; Carpp, Lindsay N; Benkeser, David; Brown, Elizabeth R; Carone, Marco; Cho, Iksung; Donnell, Deborah; Fay, Michael P; Fong, Youyi; Han, Shu; Hirsch, Ian; Huang, Ying; Huang, Yunda; Hyrien, Ollivier; Juraska, Michal; Luedtke, Alex; Nason, Martha; Vandebosch, An; Zhou, Honghong; Cohen, Myron S; Corey, Lawrence; Hartzel, Jonathan; Follmann, Dean; Gilbert, Peter B.
  • Mehrotra DV; Biostatistics and Research Decision Sciences, Merck & Co., North Wales, Pennsylvania (D.V.M., J.H.).
  • 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.).
  • 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.).
  • Annunziato PW; Vaccines Clinical Research, Merck & Co., Kenilworth, New Jersey (P.W.A.).
  • Neuzil KM; University of Maryland School of Medicine, Baltimore, Maryland (K.M.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.).
  • Benkeser D; Rollins School of Public Health, Emory University, Atlanta, Georgia (D.B.).
  • 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.).
  • 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.).
  • Cho I; Novavax, Gaithersburg, Maryland (I.C.).
  • 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.).
  • Fay MP; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland (M.P.F., M.N., D.F.).
  • 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.).
  • Han S; Moderna, Cambridge, Massachusetts (S.H., H.Z.).
  • Hirsch I; AstraZeneca, Cambridge, United Kingdom (I.H.).
  • 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.).
  • 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.).
  • 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.).
  • 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.).
  • Luedtke A; University of Washington, Seattle, Washington (A.L.).
  • Nason M; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland (M.P.F., M.N., D.F.).
  • Vandebosch A; Janssen Pharmaceuticals, Beerse, Belgium (A.V.).
  • Zhou H; Moderna, Cambridge, Massachusetts (S.H., H.Z.).
  • Cohen MS; Institute for Global Health and Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina (M.S.C.).
  • 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.).
  • Hartzel J; Biostatistics and Research Decision Sciences, Merck & Co., North Wales, Pennsylvania (D.V.M., J.H.).
  • Follmann D; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland (M.P.F., M.N., D.F.).
  • 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.).
Ann Intern Med ; 174(2): 221-228, 2021 02.
Artículo en Inglés | MEDLINE | ID: covidwho-890662
ABSTRACT
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.
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Texto completo: Disponible Colección: Bases de datos internacionales Base de datos: MEDLINE Asunto principal: Ensayos Clínicos Controlados Aleatorios como Asunto / Vacunas contra la COVID-19 / COVID-19 Tipo de estudio: Estudios diagnósticos / Estudio experimental / Estudio pronóstico / Ensayo controlado aleatorizado Tópicos: Vacunas Límite: Humanos Idioma: Inglés Revista: Ann Intern Med Año: 2021 Tipo del documento: Artículo

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Texto completo: Disponible Colección: Bases de datos internacionales Base de datos: MEDLINE Asunto principal: Ensayos Clínicos Controlados Aleatorios como Asunto / Vacunas contra la COVID-19 / COVID-19 Tipo de estudio: Estudios diagnósticos / Estudio experimental / Estudio pronóstico / Ensayo controlado aleatorizado Tópicos: Vacunas Límite: Humanos Idioma: Inglés Revista: Ann Intern Med Año: 2021 Tipo del documento: Artículo