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Author Notes:

Dean Follmann, Email: dfollmann@niaid.nih.gov

Conceptualization: D.F., M.M., and M.F. Methodology: D.F., M.F., and J.F. Formal Analysis: D.F., M.F., J.F., and A.M. Writing – original draft: D.F., M.C., M.O.B., and M.M. Writing – review & editing: D.F., J.F., M.P.F., D.M., A.M., H.M.E.S., H.J., N.D.-R., D.B., Y.F., M.M., M.P.O., G.A.H., A.H., K.-C.C., E.F.-N., K.C.T., F.I., L.R.B., J.M., H.Z., W.D., P.G.B., and M.S.C.

We thank the volunteers who participated in the COV-2069 and COVE clinical trials. We thank Heather Angier for assistance with technical editing. This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under Contract No. 75N91019D00024. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. These studies were supported by the National Institutes of Health/National Institute of Allergy and Infectious Diseases. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

D.F., J.F., M.P.F., D.M., A.M., H.M.E.S., H.J., N.D.-R., D.B., Y.F., and M.M. have no competing interests to declare. M.P.O. is an employee, has stock options, a patent pending, and license and royalties with Regeneron Pharmaceuticals, Inc. G.A.H. is an employee and shareholder of Regeneron and is listed on pending patents for the REGEN-COV antibody cocktail. A.H. owns stock in Regeneron and Pfizer. K.-C.C. and E.F.-N. are employees and shareholders of Regeneron. K.C.T. and F.I. are employees and shareholders of Regeneron and are listed on a pending patent. L.R.B. is the Deputy Editor for the New England Journal of Medicine and has grants from the Bill and Melinda Gates Foundation, Harvard Medical School, the National Institutes of Health, and the Wellcome Trust. J.M. is an employee of and has stock options and stock grants from Moderna. H.Z. is an employee of and has stock options from Moderna. W.D. is an employee of Moderna. P.G.B. will be serving as an unpaid advisor on Moderna’s Zika Vaccine Advisory Board. M.S.C. serves on the scientific advisory boards of Aerium, ModexX, and Atea and has consulting roles with Astra Zenica and GSK.

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Research Funding:

Open Access funding provided by the National Institutes of Health (NIH).

Keywords:

  • Science & Technology
  • Multidisciplinary Sciences
  • Science & Technology - Other Topics

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

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Journal Title:

NATURE COMMUNICATIONS

Volume:

Volume 14, Number 1

Publisher:

, Pages 3605-3605

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2023

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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