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

Dean Follmann (), Meagan P. O’Brien, Jonathan Fintzi, Michael P. Fay, David Montefiori, Allyson Mateja, Gary A. Herman, Andrea T. Hooper, Kenneth C. Turner, Kuo- Chen Chan, Eduardo Forleo-Neto, Flonza Isa, Lindsey R. Baden, Hana M. El Sahly, Holly Janes, Nicole Doria-Rose, Jacqueline Miller, Honghong Zhou, Weiping Dang, David Benkeser, Youyi Fong, Peter B. Gilbert, Mary Marovich and Myron S. Cohen
Additional contact information
Dean Follmann: National Institutes of Health
Meagan P. O’Brien: Regeneron Pharmaceuticals, Inc.
Jonathan Fintzi: National Institutes of Health
Michael P. Fay: National Institutes of Health
David Montefiori: Duke University Medical Center
Allyson Mateja: Frederick National Laboratory for Cancer Research
Gary A. Herman: Regeneron Pharmaceuticals, Inc.
Andrea T. Hooper: Regeneron Pharmaceuticals, Inc.
Kenneth C. Turner: Regeneron Pharmaceuticals, Inc.
Kuo- Chen Chan: Regeneron Pharmaceuticals, Inc.
Eduardo Forleo-Neto: Regeneron Pharmaceuticals, Inc.
Flonza Isa: Regeneron Pharmaceuticals, Inc.
Lindsey R. Baden: Brigham and Women’s Hospital
Hana M. El Sahly: Baylor College of Medicine
Holly Janes: Fred Hutchinson Cancer Research Center
Nicole Doria-Rose: National Institutes of Health
Jacqueline Miller: Moderna, Inc.
Honghong Zhou: Moderna, Inc.
Weiping Dang: Moderna, Inc.
David Benkeser: Emory University
Youyi Fong: Fred Hutchinson Cancer Research Center
Peter B. Gilbert: Fred Hutchinson Cancer Research Center
Mary Marovich: National Institutes of Health
Myron S. Cohen: The University of North Carolina at Chapel Hill

Nature Communications, 2023, vol. 14, issue 1, 1-9

Abstract: Abstract 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.

Date: 2023
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DOI: 10.1038/s41467-023-39292-w

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