| Author | Carpp, Lindsay N. | |
| Author | Hyrien, Ollivier | |
| Author | Fong, Youyi | |
| Author | Benkeser, David | |
| Author | Roels, Sanne | |
| Author | Stieh, Daniel J. | |
| Author | Dromme, Ilse Van | |
| Author | Roey, Griet A. Van | |
| Author | Kenny, Avi | |
| Author | Huang, Ying | |
| Author | Carone, Marco | |
| Author | McDermott, Adrian B. | |
| Author | Houchens, Christopher R. | |
| Author | Martins, Karen | |
| Author | Jayashankar, Lakshmi | |
| Author | Castellino, Flora | |
| Author | Amoa-Awua, Obrimpong | |
| Author | Basappa, Manjula | |
| Author | Flach, Britta | |
| Author | Lin, Bob C. | |
| Author | Moore, Christopher | |
| Author | Naisan, Mursal | |
| Author | Naqvi, Muhammed | |
| Author | Narpala, Sandeep | |
| Author | O'Connell, Sarah | |
| Author | Mueller, Allen | |
| Author | Serebryannyy, Leo | |
| Author | Castro, Mike | |
| Author | Wang, Jennifer | |
| Author | Petropoulos, Christos J. | |
| Author | Luedtke, Alex | |
| Author | Lu, Yiwen | |
| Author | Yu, Chenchen | |
| Author | Juraska, Michal | |
| Author | Hejazi, Nima S. | |
| Author | Wolfe, Daniel N. | |
| Author | Sadoff, Jerald | |
| Author | Gray, Glenda E. | |
| Author | Grinsztejn, Beatriz | |
| Author | Goepfert, Paul A. | |
| Author | Bekker, Linda-Gail | |
| Author | Gaur, Aditya H. | |
| Author | Veloso, Valdiléa G. | |
| Author | Randhawa, April K. | |
| Author | Andrasik, Michele P. | |
| Author | Hendriks, Jenny | |
| Author | Truyers, Carla | |
| Author | Vandebosch, An | |
| Author | Struyf, Frank | |
| Author | Schuitemaker, Hanneke | |
| Author | Douoguih, Macaya | |
| Author | Kublin, James G. | |
| Author | Corey, Lawrence | |
| Author | Neuzil, Kathleen M. | |
| Author | Follmann, Dean | |
| Author | Koup, Richard A. | |
| Author | Donis, Ruben O. | |
| Author | Gilbert, Peter B. | |
| Access date | 2025-02-19T00:02:08Z | |
| Available date | 2025-02-19T00:02:08Z | |
| Document date | 2024 | |
| Citation | CARPP, Lindsay N. et al. Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial. Nature Communications, v. 15, n. 1, p. 1-18, Nov. 2024. | en_US |
| ISSN | 2041-1723 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/68627 | |
| Description | On behalf of the Immune Assays Team: 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, Daniel N. Wolfe, Richard A. Koup & Ruben O. Donis. | |
| Description | The Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team: Ilse Van Dromme, Griet A. Van Roey, Jerald Sadoff, Glenda E. Gray, Beatriz Grinsztejn, Paul A. Goepfert, Linda-Gail Bekker, Aditya H. Gaur, Jenny Hendriks, Carla Truyers, An Vandebosch, Frank Struyf, Hanneke Schuitemaker, Macaya Douoguih, James G. Kublin, Lawrence Corey & Kathleen M. Neuzil. | |
| Description | The United States Government (USG)/CoVPN Biostatistics Team: Lindsay N. Carpp, Ollivier Hyrien, Youyi Fong, David Benkeser, Avi Kenny, Ying Huang, Marco Carone, Alex Luedtke, Yiwen Lu, Chenchen Yu, Michal Juraska, Nima S. Hejazi, April K. Randhawa, Dean Follmann & Peter B. Gilbert. | |
| Language | eng | en_US |
| Publisher | Nature Pub. | en_US |
| Rights | open access | en_US |
| Title | Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial | en_US |
| Type | Article | en_US |
| DOI | 10.1038/s41467-024-53727-y | |
| 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 [<4.8975 International Units (IU)50/ml], 85.2% (47.2%, 95.3%) at just-quantifiable (5.2 IU50/ml), and 95.1% (81.1%, 96.9%) at 90th percentile (30.2 IU50/ml). At the same titers, VE against moderate COVID-19 is 32.5% (11.8%, 48.4%), 33.9% (19.1%, 59.3%), and 60.7% (40.4%, 76.4%). Protection against moderate vs. severe disease may require higher antibody levels, and very low antibody levels and/or other immune responses may associate with protection against severe disease. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA. | en_US |
| Affilliation | Emory University. Rollins School of Public Health. Department of Biostatistics and Bioinformatics. Atlanta, GA, USA. | en_US |
| Affilliation | Johnson & Johnson Innovative Medicine. Beerse, Belgium. | en_US |
| Affilliation | Vaccine Company Inc. South San Francisco, CA, USA / Janssen Vaccines and Prevention. Leiden, The Netherlands. | en_US |
| Affilliation | Johnson & Johnson Innovative Medicine. Beerse, Belgium. | en_US |
| Affilliation | Janssen Vaccines and Prevention. Leiden, The Netherlands. | en_US |
| Affilliation | Duke University. Duke Global Health Institute. Durham, NC, USA / University of Washington School of Public Health. Department of Biostatistics. Seattle, WA, USA. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA / University of Washington School of Public Health. Department of Biostatistics. Seattle, WA, USA. | en_US |
| Affilliation | University of Washington School of Public Health. Department of Biostatistics. Seattle, WA, USA. | en_US |
| Affilliation | Sanofi Vaccines R&D. Marcy l’étoile, France / National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | Biomedical Advanced Research and Development Authority. Washington, DC, USA. | en_US |
| Affilliation | Biomedical Advanced Research and Development Authority. Washington, DC, USA. | en_US |
| Affilliation | Biomedical Advanced Research and Development Authority. Washington, DC, USA. | en_US |
| Affilliation | Biomedical Advanced Research and Development Authority. Washington, DC, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | LabCorp-Monogram Biosciences. South San Francisco, CA, USA. | en_US |
| Affilliation | University of Washington. Department of Statistics. Seattle, WA, USA. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Harvard University. T.H. Chan School of Public Health. Department of Biostatistics. Boston, MA, USA. | en_US |
| Affilliation | Biomedical Advanced Research and Development Authority. Washington, DC, USA. | en_US |
| Affilliation | Centivax. South San Francisco, CA, USA / Janssen Vaccines and Prevention. Leiden, The Netherlands. | en_US |
| Affilliation | University of the Witwatersrand. Faculty of Health Sciences. Perinatal HIV Research Unit. Johannesburg, South Africa / South African Medical Research Council. Cape Town, South Africa. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | University of Alabama at Birmingham. Department of Medicine. Division of Infectious Diseases. Birmingham, AL, USA. | en_US |
| Affilliation | University of Cape Town. Institute of Infectious Disease and Molecular Medicine. Observatory, Cape Town, South Africa / University of Cape Town and Groote Schuur Hospital. Department of Medicine. Observatory, Cape Town, South Africa / University of Cape Town. Desmond Tutu HIV Centre. Cape Town, South Africa. | en_US |
| Affilliation | St. Jude Children’s Research Hospital. Department of Infectious Diseases. Memphis, TN, USA. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | en_US |
| Affilliation | Janssen Vaccines and Prevention. Leiden, The Netherlands. | en_US |
| Affilliation | Johnson & Johnson Innovative Medicine. Beerse, Belgium. | en_US |
| Affilliation | Argenx BV. Ghent, Belgium / Johnson & Johnson Innovative Medicine. Beerse, Belgium. | en_US |
| Affilliation | GSK. Wavre, Belgium / Johnson & Johnson Innovative Medicine. Beerse, Belgium. | en_US |
| Affilliation | Valneva. Saint-Herblain, France / Janssen Vaccines and Prevention. Leiden, The Netherlands. | en_US |
| Affilliation | Merck. Rahway, NJ, USA / Janssen Vaccines and Prevention. Leiden, The Netherlands. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / University of Washington. Department of Laboratory Medicine and Pathology. Seattle, WA, USA. | en_US |
| Affilliation | Fogarty International Center. Bethesda, MD, USA / University of Maryland School of Medicine. Center for Vaccine Development and Global Health. Baltimore, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Biostatistics Research Branch. Bethesda, MD, USA. | en_US |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
| Affilliation | Biomedical Advanced Research and Development Authority. Washington, DC, USA. | en_US |
| Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA / University of Washington School of Public Health. Department of Biostatistics. Seattle, WA, USA. | en_US |
| Subject | Severe COVID-19 | en_US |
| Subject | Ad26.COV2.S | en_US |
| Subject | ENSEMBLE | en_US |
| Subject | COVID-19 vaccine efficacy | en_US |
| e-ISSN | 2041-1723 | |
