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Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial

Author

Listed:
  • Lindsay N. Carpp

    (Fred Hutchinson Cancer Center)

  • Ollivier Hyrien

    (Fred Hutchinson Cancer Center
    Fred Hutchinson Cancer Center)

  • Youyi Fong

    (Fred Hutchinson Cancer Center
    Fred Hutchinson Cancer Center)

  • David Benkeser

    (Emory University)

  • Sanne Roels

    (Johnson & Johnson Innovative Medicine)

  • Daniel J. Stieh

    (Janssen Vaccines and Prevention
    Vaccine Company Inc.)

  • Ilse Van Dromme

    (Johnson & Johnson Innovative Medicine)

  • Griet A. Van Roey

    (Janssen Vaccines and Prevention)

  • Avi Kenny

    (University of Washington School of Public Health
    Duke University
    Duke University)

  • Ying Huang

    (Fred Hutchinson Cancer Center
    Fred Hutchinson Cancer Center
    University of Washington School of Public Health)

  • Marco Carone

    (University of Washington School of Public Health)

  • Adrian B. McDermott

    (National Institutes of Health
    Sanofi Vaccines R&D)

  • 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)

  • Obrimpong Amoa-Awua

    (National Institutes of Health)

  • Manjula Basappa

    (National Institutes of Health)

  • Britta Flach

    (National Institutes of Health)

  • Bob C. Lin

    (National Institutes of Health)

  • Christopher Moore

    (National Institutes of Health)

  • Mursal Naisan

    (National Institutes of Health)

  • Muhammed Naqvi

    (National Institutes of Health)

  • Sandeep Narpala

    (National Institutes of Health)

  • Sarah O’Connell

    (National Institutes of Health)

  • Allen Mueller

    (National Institutes of Health)

  • Leo Serebryannyy

    (National Institutes of Health)

  • Mike Castro

    (National Institutes of Health)

  • Jennifer Wang

    (National Institutes of Health)

  • Christos J. Petropoulos

    (LabCorp-Monogram Biosciences)

  • Alex Luedtke

    (University of Washington)

  • Yiwen Lu

    (Fred Hutchinson Cancer Center)

  • Chenchen Yu

    (Fred Hutchinson Cancer Center)

  • Michal Juraska

    (Fred Hutchinson Cancer Center)

  • Nima S. Hejazi

    (Fred Hutchinson Cancer Center
    Harvard University)

  • Daniel N. Wolfe

    (Biomedical Advanced Research and Development Authority)

  • Jerald Sadoff

    (Janssen Vaccines and Prevention
    Centivax)

  • Glenda E. Gray

    (University of the Witwatersrand
    South African Medical Research Council)

  • Beatriz Grinsztejn

    (Evandro Chagas National Institute of Infectious Diseases-Fundação Oswaldo Cruz)

  • Paul A. Goepfert

    (University of Alabama at Birmingham)

  • Linda-Gail Bekker

    (Observatory
    Observatory
    University of Cape Town)

  • Aditya H. Gaur

    (St. Jude Children’s Research Hospital)

  • Valdilea G. Veloso

    (Evandro Chagas National Institute of Infectious Diseases-Fundação Oswaldo Cruz)

  • April K. Randhawa

    (Fred Hutchinson Cancer Center)

  • Michele P. Andrasik

    (Fred Hutchinson Cancer Center)

  • Jenny Hendriks

    (Janssen Vaccines and Prevention)

  • Carla Truyers

    (Johnson & Johnson Innovative Medicine)

  • An Vandebosch

    (Johnson & Johnson Innovative Medicine
    argenx BV)

  • Frank Struyf

    (Johnson & Johnson Innovative Medicine
    GSK)

  • Hanneke Schuitemaker

    (Janssen Vaccines and Prevention
    Valneva)

  • Macaya Douoguih

    (Janssen Vaccines and Prevention
    Merck)

  • James G. Kublin

    (Fred Hutchinson Cancer Center)

  • Lawrence Corey

    (Fred Hutchinson Cancer Center
    University of Washington)

  • Kathleen M. Neuzil

    (University of Maryland School of Medicine
    Fogarty International Center)

  • Dean Follmann

    (National Institutes of Health)

  • 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 School of Public Health)

Abstract

Assessment of immune correlates of severe COVID-19 has been hampered by the low numbers of severe cases in COVID-19 vaccine efficacy (VE) trials. We assess neutralizing and binding antibody levels at 4 weeks post-Ad26.COV2.S vaccination as correlates of risk and of protection against severe-critical COVID-19 through 220 days post-vaccination in the ENSEMBLE trial (NCT04505722), constituting ~4.5 months longer follow-up than our previous correlates analysis and enabling inclusion of 42 severe-critical vaccine-breakthrough cases. Neutralizing antibody titer is a strong inverse correlate of severe-critical COVID-19, with estimated hazard ratio (HR) per 10-fold increase 0.35 (95% CI: 0.13, 0.90). In a multivariable model, HRs are 0.31 (0.11, 0.89) for neutralizing antibody titer and 1.22 (0.49, 3.02) for anti-Spike binding antibody concentration. VE against severe-critical COVID-19 rises with neutralizing antibody titer: 63.1% (95% CI: 40.0%, 77.3%) at unquantifiable [

Suggested Citation

  • Lindsay N. Carpp & Ollivier Hyrien & Youyi Fong & David Benkeser & Sanne Roels & Daniel J. Stieh & Ilse Van Dromme & Griet A. Van Roey & Avi Kenny & Ying Huang & Marco Carone & Adrian B. McDermott & C, 2024. "Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial," Nature Communications, Nature, vol. 15(1), pages 1-18, December.
    • Handle: RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-53727-y
    DOI: 10.1038/s41467-024-53727-y
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    References listed on IDEAS

    as
    1. Deborah Cromer & Megan Steain & Arnold Reynaldi & Timothy E. Schlub & Shanchita R. Khan & Sarah C. Sasson & Stephen J. Kent & David S. Khoury & Miles P. Davenport, 2023. "Predicting vaccine effectiveness against severe COVID-19 over time and against variants: a meta-analysis," Nature Communications, Nature, vol. 14(1), pages 1-9, December.
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    3. Nima S. Hejazi & Mark J. van der Laan & Holly E. Janes & Peter B. Gilbert & David C. Benkeser, 2021. "Efficient nonparametric inference on the effects of stochastic interventions under two‐phase sampling, with applications to vaccine efficacy trials," Biometrics, The International Biometric Society, vol. 77(4), pages 1241-1253, December.
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