Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials
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Mehrotra, D.V, et al. Clinical Endpoints for Evaluating Efficacy In Covid-19 Vaccine Trials. American College of Physicians, 2021. https://doi.org/10.17615/rkbd-nv74APA
Mehrotra, D., Janes, H., Fleming, T., Annunziato, P., Neuzil, K., Carpp, L., Benkeser, D., Brown, E., Carone, M., Cho, I., Donnell, D., Fay, M., Fong, Y., Han, S., Hirsch, I., Huang, Y., Hyrien, O., Juraska, M., Luedtke, A., Nason, M., Vandebosch, A., Zhou, H., Cohen, M., Corey, L., Hartzel, J., Follmann, D., & Gilbert, P. (2021). Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials. American College of Physicians. https://doi.org/10.17615/rkbd-nv74Chicago
Mehrotra, D.V., H.E Janes, T.R Fleming, P.W Annunziato, K.M Neuzil, L.N Carpp, D Benkeser et al. 2021. Clinical Endpoints for Evaluating Efficacy In Covid-19 Vaccine Trials. American College of Physicians. https://doi.org/10.17615/rkbd-nv74- Creator
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Mehrotra, D.V.
- Other Affiliation: Merck and Co.
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Janes, H.E.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Fleming, T.R.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Annunziato, P.W.
- Other Affiliation: Merck and Co.
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Neuzil, K.M.
- Other Affiliation: University of Maryland
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Carpp, L.N.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Benkeser, D.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Brown, E.R.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Carone, M.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Cho, I.
- Other Affiliation: Novavax
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Donnell, D.
- Other Affiliation: Emory University
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Fay, M.P.
- Other Affiliation: National Institute of Allergy and Infectious Diseases
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Fong, Y.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Han, S.
- Other Affiliation: Moderna Inc.
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Hirsch, I.
- Other Affiliation: AstraZeneca
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Huang, Y.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Huang, Y.
- Other Affiliation: Merck and Co.
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Hyrien, O.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Juraska, M.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Luedtke, A.
- Other Affiliation: University of Washington,
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Nason, M.
- Other Affiliation: National Institute of Allergy and Infectious Diseases
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Vandebosch, A.
- Other Affiliation: Janssen Pharmaceuticals NV
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Zhou, H.
- Other Affiliation: Moderna
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Cohen, M.S.
- Affiliation: School of Medicine, Institute for Global Health and Infectious Diseases
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Corey, L.
- Other Affiliation: Fred Hutchinson Cancer Research Center
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Hartzel, J.
- Other Affiliation: Merck and Co.
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Follmann, D.
- Other Affiliation: National Institute of Allergy and Infectious Diseases
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Gilbert, P.B.
- Other Affiliation: Fred Hutchinson Cancer Research Center
- 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.
- Date of publication
- 2021
- Keyword
- coronavirus disease 2019
- human
- diagnosis
- Asymptomatic Infections
- drug therapy
- prevention and control
- COVID-19 Testing
- adverse event
- comparative effectiveness
- Clinical Trials, Phase III as Topic
- SARS-CoV-2 vaccine
- Severity of Illness Index
- Humans
- follow up
- procedures
- severity of illness index
- randomized controlled trial (topic)
- asymptomatic infection
- phase 3 clinical trial (topic)
- Article
- placebo
- COVID-19 Vaccines
- asymptomatic coronavirus disease 2019
- Randomized Controlled Trials as Topic
- drug efficacy
- SARS-CoV-2
- COVID-19
- DOI
- Identifier
- Resource type
- Article
- Journal title
- Annals of Internal Medicine
- Journal volume
- 174
- Journal issue
- 2
- Page start
- 221
- Page end
- 229
- Language
- English
- Funder
- National Institutes of Health, NIH
- National Institute of Allergy and Infectious Diseases, NIAID: R01AI029168, R37AI054165, UM1AI068614, UM1AI068635
- ISSN
- 0003-4819
- Publisher
- American College of Physicians
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