Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials

被引：70

作者：

Mehrotra, Devan, V ^{[1
]}

Janes, Holly E. ^{[2
,13
]}

Fleming, Thomas R. ^{[2
,3
,14
]}

Annunziato, Paula W. ^{[4
]}

Neuzil, Kathleen M. ^{[5
]}

Carpp, Lindsay N. ^{[2
,13
]}

Benkeser, David ^{[2
,6
]}

Brown, Elizabeth R. ^{[2
,3
,14
,15
]}

Carone, Marco ^{[2
,3
,14
,15
]}

Cho, Iksung ^{[7
,16
]}

Donnell, Deborah ^{[13
]}

Fay, Michael P. ^{[8
,17
]}

Fong, Youyi ^{[2
,13
]}

Han, Shu ^{[9
]}

Hirsch, Ian ^{[10
,18
]}

Huang, Ying ^{[2
,13
]}

Huang, Yunda ^{[2
,13
]}

Hyrien, Ollivier ^{[2
,13
]}

Juraska, Michal ^{[2
,13
]}

Luedtke, Alex ^{[3
,19
]}

Nason, Martha ^{[8
,17
]}

Vandebosch, An ^{[11
,20
]}

Zhou, Honghong ^{[9
]}

Cohen, Myron S. ^{[12
]}

Corey, Lawrence ^{[2
,3
,13
,21
,22
]}

Hartzel, Jonathan ^{[1
]}

Follmann, Dean ^{[8
,17
]}

Gilbert, Peter B. ^{[2
,3
,14
,15
]}

机构：

[1] Merck & Co Inc, Biostat & Res Decis Sci, UG1CD-44,351 North Sumneytown Pike, N Wales, PA 19454 USA

[2] Fred Hutchinson Canc Res Ctr, 1124 Columbia St, Seattle, WA 98104 USA

[3] Univ Washington, Seattle, WA 98195 USA

[4] Merck & Co Inc, Vaccines Clin Res, 2000 Galloping Hill Rd, Kenilworth, NJ 07033 USA

[5] Univ Maryland, Sch Med, Baltimore, MD 21201 USA

[6] Emory Univ, Rollins Sch Publ Hlth, 1518 Clifton Rd, Atlanta, GA 30322 USA

[7] Novavax, Gaithersburg, MD USA

[8] NIAID, 9000 Rockville Pike, Bethesda, MD 20892 USA

[9] Moderna, 200 Technol Sq, Cambridge, MA 02139 USA

[10] AstraZeneca, Cambridge, England

[11] Janssen Pharmaceut, Beerse, Belgium

[12] Univ N Carolina, Inst Global Hlth & Infect Dis, 130 Mason Farm Rd,2nd Floor, Chapel Hill, NC 27599 USA

[13] Fred Hutchinson Canc Res Ctr, Vaccine & Infect Dis Div, 1100 Fairview Av, Seattle, WA 98109 USA

[14] Univ Washington, Dept Biostat, 1705 NE Pacific St, Seattle, WA 98195 USA

[15] Fred Hutchinson Canc Res Ctr, Vaccine & Infect Dis Div, 1100 Fairview Ave North, Seattle, WA 98109 USA

[16] Novavax, Biostat, 21 Firstfield Rd, Gaithersburg, MD 20878 USA

[17] NIAID, Biostat Res Branch, 5601 Fishers Lane,MSC 9820, Bethesda, MD 20892 USA

[18] AstraZeneca, BioPharmaceut R&D, Late Stage Dev, Biometr, 1 Francis Crick Ave, Cambridge CB2 0AA, England

[19] Univ Washington, Dept Stat, B313 Padelford Hall,Northeast Stevens Way, Seattle, WA 98195 USA

[20] Janssen Pharmaceut NV, Janssen R&D, Turnhoutseweg 30, B-2340 Beerse, Belgium

[21] Univ Washington, Dept Med, 1959 NE Pacific St, Seattle, WA 98195 USA

[22] Univ Washington, Dept Lab Med, 1959 NE Pacific St, Seattle, WA 98195 USA

来源：

ANNALS OF INTERNAL MEDICINE | 2021年 / 174卷 / 02期

基金：

美国国家卫生研究院;

关键词：

PARAINFLUENZA VIRUS-VACCINE; PREVENTION; INFANTS;

D O I：

10.7326/M20-6169

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：221 / +

页数：9

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