Author | Fong, Youyi | |
Author | McDermott, Adrian B. | |
Author | Benkeser, David | |
Author | Roels, Sanne | |
Author | Stieh, Daniel J. | |
Author | Vandebosch, An | |
Author | Le Gars, Mathieu | |
Author | Roey, Griet A. Van | |
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 | Hyrien, Ollivier | |
Author | Lu, Yiwen | |
Author | Yu, Chenchen | |
Author | Borate, Bhavesh | |
Author | Laan, Lars W. P. Van Der | |
Author | Hejazi, Nima S. | |
Author | Kenny, Avi | |
Author | Carone, Marco | |
Author | Wolfe, Daniel N. | |
Author | Sadoff, Jerald | |
Author | Gray, Glenda E. | |
Author | Grinsztejn, Beatriz | |
Author | Goepfert, Paul A. | |
Author | Little, Susan J. | |
Author | Sousa, Leonardo Paiva de | |
Author | Maboa, Rebone | |
Author | Randhawa, April K. | |
Author | Andrasik, Michele P. | |
Author | Hendriks, Jenny | |
Author | Truyers, Carla | |
Author | Struyf, Frank | |
Author | Schuitemaker, Hanneke | |
Author | Douoguih, Macaya | |
Author | Kublin, James G. | |
Author | Corey, Lawrence | |
Author | Neuzil, Kathleen M. | |
Author | Carpp, Lindsay N. | |
Author | Follmann, Dean | |
Author | Gilbert, Peter B. | |
Author | Koup, Richard A. | |
Author | Donis, Ruben O. | |
Access date | 2023-01-09T11:59:24Z | |
Available date | 2023-01-09T11:59:24Z | |
Document date | 2022 | |
Citation | FONG, Youyi et al. Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial. Nature microbiology, v. 7, n. 12, p. 1996-2010, 2022. | en_US |
ISSN | 2058-5276 | en_US |
URI | https://www.arca.fiocruz.br/handle/icict/56387 | |
Language | eng | en_US |
Publisher | Nature | en_US |
Rights | open access | en_US |
Title | Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial | en_US |
Type | Article | en_US |
DOI | 10.1038/s41564-022-01262-1 | |
Abstract | Measuring immune correlates of disease acquisition and protection in the context of a clinical trial is a prerequisite for improved vaccine design. We analysed binding and neutralizing antibody measurements 4 weeks post vaccination as correlates of risk of moderate to severe-critical COVID-19 through 83 d post vaccination in the phase 3, double-blind placebo-controlled phase of ENSEMBLE, an international randomized efficacy trial of a single dose of Ad26.COV2.S. We also evaluated correlates of protection in the trial cohort. Of the three antibody immune markers we measured, we found most support for 50% inhibitory dilution (ID50) neutralizing antibody titre as a correlate of risk and of protection. The outcome hazard ratio was 0.49 (95% confidence interval 0.29, 0.81; P = 0.006) per 10-fold increase in ID50; vaccine efficacy was 60% (43%, 72%) at non-quantifiable ID50 (<2.7 IU50 ml-1) and increased to 89% (78%, 96%) at ID50 = 96.3 IU50 ml-1. Comparison of the vaccine efficacy by ID50 titre curves for ENSEMBLE-US, the COVE trial of the mRNA-1273 vaccine and the COV002-UK trial of the AZD1222 vaccine supported the ID50 titre as a correlate of protection across trials and vaccine types. | 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 | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | en_US |
Affilliation | Emory University. Rollins School of Public Health. Department of Biostatistics and Bioinformatics. Atlanta, GA, USA. | en_US |
Affilliation | Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium. | en_US |
Affilliation | Janssen Vaccines and Prevention. Leiden, the Netherlands. | en_US |
Affilliation | Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium. | en_US |
Affilliation | Janssen Vaccines and Prevention. Leiden, the Netherlands. | en_US |
Affilliation | Janssen Vaccines and Prevention. Leiden, the Netherlands. | 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 / 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. | 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 / University of Washington. Department of Statistics. Seattle, WA, USA. | en_US |
Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Weill Cornell Medicine. Department of Population Health Sciences. School of Public Health. Division of Biostatistics. New York, NY, USA. | en_US |
Affilliation | 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 | Biomedical Advanced Research and Development Authority. Washington, DC, USA. | en_US |
Affilliation | 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/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 California San Diego. Division of Infectious Diseases. La Jolla, CA, USA. | en_US |
Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. | en_US |
Affilliation | Ndlovu Elandsdoorn Site. Limpopo, Dennilton, South Africa. | 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 | Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium. | en_US |
Affilliation | Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium. | en_US |
Affilliation | Janssen Vaccines and Prevention. Leiden, the Netherlands. | en_US |
Affilliation | 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 | University of Maryland School of Medicine. Center for Vaccine Development and Global Health. Baltimore, MD, USA. | en_US |
Affilliation | Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | en_US |
Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Biostatistics Research Branch. Bethesda, MD, 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 | 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 |
Subject | COVID-19 | en_US |
Subject | ENSEMBLE | en_US |
Subject | Vaccine efficacy | en_US |