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

Author

Listed:
  • 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
    Fred Hutchinson Cancer Research Center
    University of Washington)

  • Peter B. Gilbert

    (Fred Hutchinson Cancer Research Center
    Fred Hutchinson Cancer Research Center
    University of Washington)

  • Mary Marovich

    (National Institutes of Health
    National Institute of Allergy and Infectious Diseases)

  • Myron S. Cohen

    (The University of North Carolina at Chapel Hill)

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.

Suggested Citation

  • 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 , 2023. "Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration," Nature Communications, Nature, vol. 14(1), pages 1-9, December.
    • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-023-39292-w
    DOI: 10.1038/s41467-023-39292-w
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    Cited by:

    1. Bo Zhang & Youyi Fong & Jonathan Fintzi & Eric Chu & Holly E. Janes & Avi Kenny & Marco Carone & David Benkeser & Lars W. P. Laan & Weiping Deng & Honghong Zhou & Xiaowei Wang & Yiwen Lu & Chenchen Yu, 2024. "Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial," Nature Communications, Nature, vol. 15(1), pages 1-13, December.
    2. Rhiannon Edge & Sam Matthews & Bahar Ahani & Anastasia A. Aksyuk & Lindsay Clegg & John L. Perez & Mark T. Esser & Lee-Jah Chang & Ian Hirsch & Tonya Villafana & John Pura & Oleg Stepanov & Katie Stre, 2025. "A SARS-CoV-2 variant‑adjusted threshold of protection model for monoclonal antibody pre-exposure prophylaxis against COVID-19," Nature Communications, Nature, vol. 16(1), pages 1-14, December.
    3. Eva Stadler & Martin T. Burgess & Timothy E. Schlub & Shanchita R. Khan & Khai Li Chai & Zoe K. McQuilten & Erica M. Wood & Mark N. Polizzotto & Stephen J. Kent & Deborah Cromer & Miles P. Davenport &, 2023. "Monoclonal antibody levels and protection from COVID-19," Nature Communications, Nature, vol. 14(1), pages 1-9, December.
    4. Nonhlanhla N. Mkhize & Bo Zhang & Caroline Brackett & Peter James Elyanu & Asa Tapley & Sufia Dadabhai & Jiani Hu & Bich T. N. Do & Daniel J. Schuster & Jack Heptinstall & Sheetal Sawant & Kelly Seato, 2025. "Neutralizing and binding antibodies are a correlate of risk of COVID-19 in the CoVPN 3008 study in people with HIV," Nature Communications, Nature, vol. 16(1), pages 1-19, December.

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