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

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, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Obrimpong Amoa-Awua, Manjula Basappa, Britta Flach, Bob C. Lin, Christopher Moore, Mursal Naisan, Muhammed Naqvi, Sandeep Narpala, Sarah O’Connell, Allen Mueller, Leo Serebryannyy, Mike Castro, Jennifer Wang, Christos J. Petropoulos, Alex Luedtke, Yiwen Lu, Chenchen Yu, Michal Juraska, Nima S. Hejazi, Daniel N. Wolfe, Jerald Sadoff, Glenda E. Gray, Beatriz Grinsztejn, Paul A. Goepfert, Linda-Gail Bekker, Aditya H. Gaur, Valdilea G. Veloso, April K. Randhawa, Michele P. Andrasik, Jenny Hendriks, Carla Truyers, An Vandebosch, Frank Struyf, Hanneke Schuitemaker, Macaya Douoguih, James G. Kublin, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Richard A. Koup, Ruben O. Donis and Peter B. Gilbert ()
Additional contact information
Lindsay N. Carpp: Fred Hutchinson Cancer Center
Ollivier Hyrien: Fred Hutchinson Cancer Center
Youyi Fong: Fred Hutchinson Cancer Center
David Benkeser: Emory University
Sanne Roels: Johnson & Johnson Innovative Medicine
Daniel J. Stieh: Janssen Vaccines and Prevention
Ilse Van Dromme: Johnson & Johnson Innovative Medicine
Griet A. Van Roey: Janssen Vaccines and Prevention
Avi Kenny: University of Washington School of Public Health
Ying Huang: Fred Hutchinson Cancer Center
Marco Carone: University of Washington School of Public Health
Adrian B. McDermott: National Institutes of Health
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
Daniel N. Wolfe: Biomedical Advanced Research and Development Authority
Jerald Sadoff: Janssen Vaccines and Prevention
Glenda E. Gray: University of the Witwatersrand
Beatriz Grinsztejn: Evandro Chagas National Institute of Infectious Diseases-Fundação Oswaldo Cruz
Paul A. Goepfert: University of Alabama at Birmingham
Linda-Gail Bekker: Observatory
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
Frank Struyf: Johnson & Johnson Innovative Medicine
Hanneke Schuitemaker: Janssen Vaccines and Prevention
Macaya Douoguih: Janssen Vaccines and Prevention
James G. Kublin: Fred Hutchinson Cancer Center
Lawrence Corey: Fred Hutchinson Cancer Center
Kathleen M. Neuzil: University of Maryland School of Medicine
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

Nature Communications, 2024, vol. 15, issue 1, 1-18

Abstract: 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 [

Date: 2024
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DOI: 10.1038/s41467-024-53727-y

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