Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration.

Autor: Follmann D; Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. dfollmann@niaid.nih.gov., O'Brien MP; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Fintzi J; Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Fay MP; Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Montefiori D; Department of Surgery, Duke University Medical Center, Durham, NC, USA., Mateja A; Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA., Herman GA; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Hooper AT; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Turner KC; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Chan KC; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Forleo-Neto E; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Isa F; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Baden LR; Brigham and Women's Hospital, Boston, MA, USA., El Sahly HM; Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA., Janes H; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Doria-Rose N; Vaccine Research Center, National Institutes of Health, Bethesda, MD, USA., Miller J; Moderna, Inc., Cambridge, MA, USA., Zhou H; Moderna, Inc., Cambridge, MA, USA., Dang W; Moderna, Inc., Cambridge, MA, USA., Benkeser D; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA., Fong Y; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.; Department of Biostatistics, University of Washington, Seattle, WA, USA., Gilbert PB; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.; Department of Biostatistics, University of Washington, Seattle, WA, USA., Marovich M; Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.; Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, USA., Cohen MS; Institute for Global Health and Infectious Diseases, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Jazyk: angličtina
Zdroj: Nature communications [Nat Commun] 2023 Jun 17; Vol. 14 (1), pp. 3605. Date of Electronic Publication: 2023 Jun 17.
DOI: 10.1038/s41467-023-39292-w
Abstrakt: While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.gov #NCT04470427). In the mAb trial, protective efficacy of 92% (95% confidence interval (CI): 84%, 98%) is associated with a nAb titer of 1000 IU50/ml, with lower efficacy at lower nAb titers. In the vaccine trial, protective efficacies of 93% [95% CI: 91%, 95%] and 97% (95% CI: 95%, 98%) are associated with nAb titers of 100 and 1000 IU50/ml, respectively. These data quantitate a nAb titer correlate of protection for mAbs benchmarked alongside vaccine induced nAb titers and support nAb titer as a surrogate endpoint for authorizing new mAbs.
(© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
Databáze: MEDLINE
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