Comparing antibody assays as correlates of protection against COVID-19 in the COVE mRNA-1273 vaccine efficacy trial.


Journal

Science translational medicine
ISSN: 1946-6242
Titre abrégé: Sci Transl Med
Pays: United States
ID NLM: 101505086

Informations de publication

Date de publication:
19 04 2023
Historique:
medline: 21 4 2023
pubmed: 19 4 2023
entrez: 19 04 2023
Statut: ppublish

Résumé

The best assay or marker to define mRNA-1273 vaccine-induced antibodies as a correlate of protection (CoP) is unclear. In the COVE trial, participants received two doses of the mRNA-1273 COVID-19 vaccine or placebo. We previously assessed IgG binding antibodies to the spike protein (spike IgG) or receptor binding domain (RBD IgG) and pseudovirus neutralizing antibody 50 or 80% inhibitory dilution titer measured on day 29 or day 57, as correlates of risk (CoRs) and CoPs against symptomatic COVID-19 over 4 months after dose. Here, we assessed a new marker, live virus 50% microneutralization titer (LV-MN

Identifiants

pubmed: 37075127
doi: 10.1126/scitranslmed.ade9078
pmc: PMC10243212
mid: NIHMS1899084
doi:

Substances chimiques

2019-nCoV Vaccine mRNA-1273 EPK39PL4R4
Antibodies, Neutralizing 0
Immunoglobulin G 0
Antibodies, Viral 0

Banques de données

ClinicalTrials.gov
['NCT04470427']

Types de publication

Randomized Controlled Trial Journal Article Research Support, U.S. Gov't, Non-P.H.S. Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

eade9078

Subventions

Organisme : NIH HHS
ID : S10 OD028685
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI148685
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 AI148684
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068635
Pays : United States

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Auteurs

David Benkeser (D)

Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.

David C Montefiori (DC)

Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC 27710, USA.

Adrian B McDermott (AB)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.

Youyi Fong (Y)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.

Holly E Janes (HE)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.

Weiping Deng (W)

Moderna Inc., Cambridge, MA 02139, USA.

Honghong Zhou (H)

Moderna Inc., Cambridge, MA 02139, USA.

Christopher R Houchens (CR)

Biomedical Advanced Research and Development Authority, Washington, DC 20201, USA.

Karen Martins (K)

Biomedical Advanced Research and Development Authority, Washington, DC 20201, USA.

Lakshmi Jayashankar (L)

Biomedical Advanced Research and Development Authority, Washington, DC 20201, USA.

Flora Castellino (F)

Biomedical Advanced Research and Development Authority, Washington, DC 20201, USA.

Britta Flach (B)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.

Bob C Lin (BC)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.

Sarah O'Connell (S)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.

Charlene McDanal (C)

Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC 27710, USA.

Amanda Eaton (A)

Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC 27710, USA.

Marcella Sarzotti-Kelsoe (M)

Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC 27710, USA.

Yiwen Lu (Y)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.

Chenchen Yu (C)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.

Bhavesh Borate (B)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.

Lars W P van der Laan (LWP)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.

Nima S Hejazi (NS)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Department of Biostatistics, T.H. Chan School of Public Health, Harvard University, Boston, MA 02115, USA.

Avi Kenny (A)

Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.

Marco Carone (M)

Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.

Brian D Williamson (BD)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Kaiser Permanente Washington Health Research Institute, Seattle, WA 98101, USA.

Jennifer Garver (J)

Battelle, West Jefferson, OH 43162, USA.

Erin Altonen (E)

Battelle, West Jefferson, OH 43162, USA.

Thomas Rudge (T)

Battelle, West Jefferson, OH 43162, USA.

Chuong Huynh (C)

Biomedical Advanced Research and Development Authority, Washington, DC 20201, USA.

Jacqueline Miller (J)

Moderna Inc., Cambridge, MA 02139, USA.

Hana M El Sahly (HM)

Baylor College of Medicine, Houston, TX 77030, USA.

Lindsey R Baden (LR)

Brigham and Women's Hospital, Boston, MA 02115, USA.

Sharon Frey (S)

Department of Internal Medicine, Saint Louis University, St. Louis, MO 63110, USA.

Elissa Malkin (E)

Vaccine Research Unit, School of Medicine and Health Sciences, George Washington University, Washington, DC 20052, USA.

Stephen A Spector (SA)

Division of Pediatric Infectious Diseases, University of California, San Diego, La Jolla, CA 92093, USA.
Rady Children's Hospital, San Diego, CA 92123, USA.

Michele P Andrasik (MP)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.

James G Kublin (JG)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.

Lawrence Corey (L)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA 98115, USA.

Kathleen M Neuzil (KM)

Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD 21201, USA.

Lindsay N Carpp (LN)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.

Rolando Pajon (R)

Moderna Inc., Cambridge, MA 02139, USA.

Dean Follmann (D)

Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.

Ruben O Donis (RO)

Biomedical Advanced Research and Development Authority, Washington, DC 20201, USA.

Richard A Koup (RA)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.

Peter B Gilbert (PB)

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.

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Classifications MeSH