Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial

Fong, Youyi; McDermott, Adrian B.; Benkeser, David; Roels, Sanne; Stieh, Daniel J.; Vandebosch, An; Le Gars, Mathieu; Roey, Griet A. Van; Houchens, Christopher R.; Martins, Karen; Jayashankar, Lakshmi; Castellino, Flora; Amoa-Awua, Obrimpong; Basappa, Manjula; Flach, Britta; Lin, Bob C.; Moore, Christopher; Naisan, Mursal; Naqvi, Muhammed; Narpala, Sandeep; O'Connell, Sarah; Mueller, Allen; Serebryannyy, Leo; Castro, Mike; Wang, Jennifer; Petropoulos, Christos J.; Luedtke, Alex; Hyrien, Ollivier; Lu, Yiwen; Yu, Chenchen; Borate, Bhavesh; Laan, Lars W. P. Van Der; Hejazi, Nima S.; Kenny, Avi; Carone, Marco; Wolfe, Daniel N.; Sadoff, Jerald; Gray, Glenda E.; Grinsztejn, Beatriz; Goepfert, Paul A.; Little, Susan J.; Sousa, Leonardo Paiva de; Maboa, Rebone; Randhawa, April K.; Andrasik, Michele P.; Hendriks, Jenny; Truyers, Carla; Struyf, Frank; Schuitemaker, Hanneke; Douoguih, Macaya; Kublin, James G.; Corey, Lawrence; Neuzil, Kathleen M.; Carpp, Lindsay N.; Follmann, Dean; Gilbert, Peter B.; Koup, Richard A.; Donis, Ruben O.

Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial

Detalhes bibliográficos
Autor(a) principal:	Fong, Youyi
Data de Publicação:	2022
Outros Autores:	McDermott, Adrian B., Benkeser, David, Roels, Sanne, Stieh, Daniel J., Vandebosch, An, Le Gars, Mathieu, Roey, Griet A. Van, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Amoa-Awua, Obrimpong, Basappa, Manjula, Flach, Britta, Lin, Bob C., Moore, Christopher, Naisan, Mursal, Naqvi, Muhammed, Narpala, Sandeep, O'Connell, Sarah, Mueller, Allen, Serebryannyy, Leo, Castro, Mike, Wang, Jennifer, Petropoulos, Christos J., Luedtke, Alex, Hyrien, Ollivier, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, Laan, Lars W. P. Van Der, Hejazi, Nima S., Kenny, Avi, Carone, Marco, Wolfe, Daniel N., Sadoff, Jerald, Gray, Glenda E., Grinsztejn, Beatriz, Goepfert, Paul A., Little, Susan J., Sousa, Leonardo Paiva de, Maboa, Rebone, Randhawa, April K., Andrasik, Michele P., Hendriks, Jenny, Truyers, Carla, Struyf, Frank, Schuitemaker, Hanneke, Douoguih, Macaya, Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Carpp, Lindsay N., Follmann, Dean, Gilbert, Peter B., Koup, Richard A., Donis, Ruben O.
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Institucional da FIOCRUZ (ARCA)
DOI:	10.1038/s41564-022-01262-1
Texto Completo:	https://www.arca.fiocruz.br/handle/icict/56387
Resumo:	Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA.

Metadados do item

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network_acronym_str	CRUZ
network_name_str	Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str	2135
spelling	Fong, YouyiMcDermott, Adrian B.Benkeser, DavidRoels, SanneStieh, Daniel J.Vandebosch, AnLe Gars, MathieuRoey, Griet A. VanHouchens, Christopher R.Martins, KarenJayashankar, LakshmiCastellino, FloraAmoa-Awua, ObrimpongBasappa, ManjulaFlach, BrittaLin, Bob C.Moore, ChristopherNaisan, MursalNaqvi, MuhammedNarpala, SandeepO'Connell, SarahMueller, AllenSerebryannyy, LeoCastro, MikeWang, JenniferPetropoulos, Christos J.Luedtke, AlexHyrien, OllivierLu, YiwenYu, ChenchenBorate, BhaveshLaan, Lars W. P. Van DerHejazi, Nima S.Kenny, AviCarone, MarcoWolfe, Daniel N.Sadoff, JeraldGray, Glenda E.Grinsztejn, BeatrizGoepfert, Paul A.Little, Susan J.Sousa, Leonardo Paiva deMaboa, ReboneRandhawa, April K.Andrasik, Michele P.Hendriks, JennyTruyers, CarlaStruyf, FrankSchuitemaker, HannekeDouoguih, MacayaKublin, James G.Corey, LawrenceNeuzil, Kathleen M.Carpp, Lindsay N.Follmann, DeanGilbert, Peter B.Koup, Richard A.Donis, Ruben O.2023-01-09T11:59:24Z2023-01-09T11:59:24Z2022FONG, 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, 2022.2058-5276https://www.arca.fiocruz.br/handle/icict/5638710.1038/s41564-022-01262-1engNatureImmune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.Emory University. Rollins School of Public Health. Department of Biostatistics and Bioinformatics. Atlanta, GA, USA.Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium.Janssen Vaccines and Prevention. Leiden, the Netherlands.Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium.Janssen Vaccines and Prevention. Leiden, the Netherlands.Janssen Vaccines and Prevention. Leiden, the Netherlands.Biomedical Advanced Research and Development Authority. Washington, DC, USA.Biomedical Advanced Research and Development Authority. Washington, DC, USA.Biomedical Advanced Research and Development Authority. Washington, DC, USA.Biomedical Advanced Research and Development Authority. Washington, DC, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.LabCorp-Monogram Biosciences. South San Francisco, CA, USA.University of Washington. Department of Statistics. Seattle, WA, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / University of Washington. Department of Statistics. Seattle, WA, USA.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.University of Washington School of Public Health. Department of Biostatistics. Seattle, WA, USA.University of Washington School of Public Health. Department of Biostatistics. Seattle, WA, USA.Biomedical Advanced Research and Development Authority. Washington, DC, USA.Janssen Vaccines and Prevention. Leiden, the Netherlands.University of the Witwatersrand. Faculty of Health Sciences. Perinatal HIV Research Unit. Johannesburg, South Africa / South African Medical Research Council. Cape Town, South Africa.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.University of Alabama at Birmingham. Department of Medicine. Division of Infectious Diseases. Birmingham, AL, USA.University of California San Diego. Division of Infectious Diseases. La Jolla, CA, USA.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.Ndlovu Elandsdoorn Site. Limpopo, Dennilton, South Africa.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.Janssen Vaccines and Prevention. Leiden, the Netherlands.Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium.Janssen R&D. a division of Janssen Pharmaceutica NV. Beerse, Belgium.Janssen Vaccines and Prevention. Leiden, the Netherlands.Janssen Vaccines and Prevention. Leiden, the Netherlands.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / University of Washington. Department of Laboratory Medicine and Pathology. Seattle, WA, USA.University of Maryland School of Medicine. Center for Vaccine Development and Global Health. Baltimore, MD, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Biostatistics Research Branch. Bethesda, MD, USA.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.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA.Biomedical Advanced Research and Development Authority. Washington, DC, USA.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.COVID-19ENSEMBLEVaccine efficacyinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZORIGINALImmune_Beatriz_Grinsztejn_etal_INI_2022.pdfImmune_Beatriz_Grinsztejn_etal_INI_2022.pdfapplication/pdf7334574https://www.arca.fiocruz.br/bitstream/icict/56387/2/Immune_Beatriz_Grinsztejn_etal_INI_2022.pdfb7010543aee4506e9a689fb783662919MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/56387/1/license.txt5a560609d32a3863062d77ff32785d58MD51icict/563872023-01-09 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dc.title.en_US.fl_str_mv	Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial
title	Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial
spellingShingle	Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial Fong, Youyi COVID-19 ENSEMBLE Vaccine efficacy
title_short	Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial
title_full	Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial
title_fullStr	Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial
title_full_unstemmed	Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial
title_sort	Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial
author	Fong, Youyi
author_facet	Fong, Youyi McDermott, Adrian B. Benkeser, David Roels, Sanne Stieh, Daniel J. Vandebosch, An Le Gars, Mathieu Roey, Griet A. Van Houchens, Christopher R. Martins, Karen Jayashankar, Lakshmi Castellino, Flora Amoa-Awua, Obrimpong Basappa, Manjula Flach, Britta Lin, Bob C. Moore, Christopher Naisan, Mursal Naqvi, Muhammed Narpala, Sandeep O'Connell, Sarah Mueller, Allen Serebryannyy, Leo Castro, Mike Wang, Jennifer Petropoulos, Christos J. Luedtke, Alex Hyrien, Ollivier Lu, Yiwen Yu, Chenchen Borate, Bhavesh Laan, Lars W. P. Van Der Hejazi, Nima S. Kenny, Avi Carone, Marco Wolfe, Daniel N. Sadoff, Jerald Gray, Glenda E. Grinsztejn, Beatriz Goepfert, Paul A. Little, Susan J. Sousa, Leonardo Paiva de Maboa, Rebone Randhawa, April K. Andrasik, Michele P. Hendriks, Jenny Truyers, Carla Struyf, Frank Schuitemaker, Hanneke Douoguih, Macaya Kublin, James G. Corey, Lawrence Neuzil, Kathleen M. Carpp, Lindsay N. Follmann, Dean Gilbert, Peter B. Koup, Richard A. Donis, Ruben O.
author_role	author
author2	McDermott, Adrian B. Benkeser, David Roels, Sanne Stieh, Daniel J. Vandebosch, An Le Gars, Mathieu Roey, Griet A. Van Houchens, Christopher R. Martins, Karen Jayashankar, Lakshmi Castellino, Flora Amoa-Awua, Obrimpong Basappa, Manjula Flach, Britta Lin, Bob C. Moore, Christopher Naisan, Mursal Naqvi, Muhammed Narpala, Sandeep O'Connell, Sarah Mueller, Allen Serebryannyy, Leo Castro, Mike Wang, Jennifer Petropoulos, Christos J. Luedtke, Alex Hyrien, Ollivier Lu, Yiwen Yu, Chenchen Borate, Bhavesh Laan, Lars W. P. Van Der Hejazi, Nima S. Kenny, Avi Carone, Marco Wolfe, Daniel N. Sadoff, Jerald Gray, Glenda E. Grinsztejn, Beatriz Goepfert, Paul A. Little, Susan J. Sousa, Leonardo Paiva de Maboa, Rebone Randhawa, April K. Andrasik, Michele P. Hendriks, Jenny Truyers, Carla Struyf, Frank Schuitemaker, Hanneke Douoguih, Macaya Kublin, James G. Corey, Lawrence Neuzil, Kathleen M. Carpp, Lindsay N. Follmann, Dean Gilbert, Peter B. Koup, Richard A. Donis, Ruben O.
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.author.fl_str_mv	Fong, Youyi McDermott, Adrian B. Benkeser, David Roels, Sanne Stieh, Daniel J. Vandebosch, An Le Gars, Mathieu Roey, Griet A. Van Houchens, Christopher R. Martins, Karen Jayashankar, Lakshmi Castellino, Flora Amoa-Awua, Obrimpong Basappa, Manjula Flach, Britta Lin, Bob C. Moore, Christopher Naisan, Mursal Naqvi, Muhammed Narpala, Sandeep O'Connell, Sarah Mueller, Allen Serebryannyy, Leo Castro, Mike Wang, Jennifer Petropoulos, Christos J. Luedtke, Alex Hyrien, Ollivier Lu, Yiwen Yu, Chenchen Borate, Bhavesh Laan, Lars W. P. Van Der Hejazi, Nima S. Kenny, Avi Carone, Marco Wolfe, Daniel N. Sadoff, Jerald Gray, Glenda E. Grinsztejn, Beatriz Goepfert, Paul A. Little, Susan J. Sousa, Leonardo Paiva de Maboa, Rebone Randhawa, April K. Andrasik, Michele P. Hendriks, Jenny Truyers, Carla Struyf, Frank Schuitemaker, Hanneke Douoguih, Macaya Kublin, James G. Corey, Lawrence Neuzil, Kathleen M. Carpp, Lindsay N. Follmann, Dean Gilbert, Peter B. Koup, Richard A. Donis, Ruben O.
dc.subject.en.en_US.fl_str_mv	COVID-19 ENSEMBLE Vaccine efficacy
topic	COVID-19 ENSEMBLE Vaccine efficacy
description	Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / Fred Hutchinson Cancer Center. Public Health Sciences Division. Seattle, WA, USA.
publishDate	2022
dc.date.issued.fl_str_mv	2022
dc.date.accessioned.fl_str_mv	2023-01-09T11:59:24Z
dc.date.available.fl_str_mv	2023-01-09T11:59:24Z
dc.type.status.fl_str_mv	info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv	info:eu-repo/semantics/article
format	article
status_str	publishedVersion
dc.identifier.citation.fl_str_mv	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.
dc.identifier.uri.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/56387
dc.identifier.issn.en_US.fl_str_mv	2058-5276
dc.identifier.doi.none.fl_str_mv	10.1038/s41564-022-01262-1
identifier_str_mv	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. 2058-5276 10.1038/s41564-022-01262-1
url	https://www.arca.fiocruz.br/handle/icict/56387
dc.language.iso.fl_str_mv	eng
language	eng
dc.rights.driver.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	Nature
publisher.none.fl_str_mv	Nature
dc.source.none.fl_str_mv	reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ
instname_str	Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str	FIOCRUZ
institution	FIOCRUZ
reponame_str	Repositório Institucional da FIOCRUZ (ARCA)
collection	Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv	https://www.arca.fiocruz.br/bitstream/icict/56387/2/Immune_Beatriz_Grinsztejn_etal_INI_2022.pdf https://www.arca.fiocruz.br/bitstream/icict/56387/1/license.txt
bitstream.checksum.fl_str_mv	b7010543aee4506e9a689fb783662919 5a560609d32a3863062d77ff32785d58
bitstream.checksumAlgorithm.fl_str_mv	MD5 MD5
repository.name.fl_str_mv	Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv	repositorio.arca@fiocruz.br
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Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial

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