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Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial

Author

Listed:
  • Youyi Fong

    (Fred Hutchinson Cancer Center
    Fred Hutchinson Cancer Center)

  • Yunda Huang

    (Fred Hutchinson Cancer Center
    University of Washington)

  • David Benkeser

    (Emory University)

  • Lindsay N. Carpp

    (Fred Hutchinson Cancer Center)

  • Germán Áñez

    (Novavax, Inc.)

  • Wayne Woo

    (Novavax, Inc.)

  • Alice McGarry

    (Novavax, Inc.)

  • Lisa M. Dunkle

    (Novavax, Inc.)

  • Iksung Cho

    (Novavax, Inc.)

  • Christopher R. Houchens

    (Biomedical Advanced Research and Development Authority)

  • Karen Martins

    (Biomedical Advanced Research and Development Authority)

  • Lakshmi Jayashankar

    (Biomedical Advanced Research and Development Authority)

  • Flora Castellino

    (Biomedical Advanced Research and Development Authority)

  • Christos J. Petropoulos

    (LabCorp-Monogram Biosciences)

  • Andrew Leith

    (Nexelis)

  • Deanne Haugaard

    (Nexelis)

  • Bill Webb

    (Nexelis)

  • Yiwen Lu

    (Fred Hutchinson Cancer Center)

  • Chenchen Yu

    (Fred Hutchinson Cancer Center)

  • Bhavesh Borate

    (Fred Hutchinson Cancer Center)

  • Lars W. P. van der Laan

    (Fred Hutchinson Cancer Center
    University of Washington)

  • Nima S. Hejazi

    (Fred Hutchinson Cancer Center
    Harvard University)

  • April K. Randhawa

    (Fred Hutchinson Cancer Center)

  • Michele P. Andrasik

    (Fred Hutchinson Cancer Center)

  • James G. Kublin

    (Fred Hutchinson Cancer Center)

  • Julia Hutter

    (National Institute of Allergy and Infectious Diseases, NIH)

  • Maryam Keshtkar-Jahromi

    (National Institute of Allergy and Infectious Diseases, NIH)

  • Tatiana H. Beresnev

    (National Institute of Allergy and Infectious Diseases, NIH)

  • Lawrence Corey

    (Fred Hutchinson Cancer Center
    University of Washington)

  • Kathleen M. Neuzil

    (University of Maryland School of Medicine)

  • Dean Follmann

    (National Institutes of Health)

  • Julie A. Ake

    (Walter Reed Army Institute of Research)

  • Cynthia L. Gay

    (University of North Carolina School of Medicine)

  • Karen L. Kotloff

    (University of Maryland School of Medicine)

  • Richard A. Koup

    (National Institutes of Health)

  • Ruben O. Donis

    (Biomedical Advanced Research and Development Authority)

  • Peter B. Gilbert

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

Abstract

In the PREVENT-19 phase 3 trial of the NVX-CoV2373 vaccine (NCT04611802), anti-spike binding IgG concentration (spike IgG), anti-RBD binding IgG concentration (RBD IgG), and pseudovirus 50% neutralizing antibody titer (nAb ID50) measured two weeks post-dose two are assessed as correlates of risk and as correlates of protection against COVID-19. Analyses are conducted in the U.S. cohort of baseline SARS-CoV-2 negative per-protocol participants using a case-cohort design that measures the markers from all 12 vaccine recipient breakthrough COVID-19 cases starting 7 days post antibody measurement and from 639 vaccine recipient non-cases. All markers are inversely associated with COVID-19 risk and directly associated with vaccine efficacy. In vaccine recipients with nAb ID50 titers of 50, 100, and 7230 international units (IU50)/ml, vaccine efficacy estimates are 75.7% (49.8%, 93.2%), 81.7% (66.3%, 93.2%), and 96.8% (88.3%, 99.3%). The results support potential cross-vaccine platform applications of these markers for guiding decisions about vaccine approval and use.

Suggested Citation

  • Youyi Fong & Yunda Huang & David Benkeser & Lindsay N. Carpp & Germán Áñez & Wayne Woo & Alice McGarry & Lisa M. Dunkle & Iksung Cho & Christopher R. Houchens & Karen Martins & Lakshmi Jayashankar & F, 2023. "Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial," Nature Communications, Nature, vol. 14(1), pages 1-15, December.
    • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-022-35768-3
    DOI: 10.1038/s41467-022-35768-3
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    References listed on IDEAS

    as
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    2. Hubbard Alan E. & Kherad-Pajouh Sara & van der Laan Mark J., 2016. "Statistical Inference for Data Adaptive Target Parameters," The International Journal of Biostatistics, De Gruyter, vol. 12(1), pages 3-19, May.
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    2. Grace Kenny & Sophie O’Reilly & Neil Wrigley Kelly & Riya Negi & Colette Gaillard & Dana Alalwan & Gurvin Saini & Tamara Alrawahneh & Nathan Francois & Matthew Angeliadis & Alejandro Abner Garcia Leon, 2023. "Distinct receptor binding domain IgG thresholds predict protective host immunity across SARS-CoV-2 variants and time," Nature Communications, Nature, vol. 14(1), pages 1-11, December.

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