Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial

In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at the time of second vaccination and 4 weeks later, with...

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Autores principales: Gilbert, Peter B., Montefiori, David C., McDermott, Adrian B., Fong, Youyi, Benkeser, David, Deng, Weiping, Zhou, Honghong, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Flach, Britta, Lin, Bob C., O’Connell, Sarah, McDanal, Charlene, Eaton, Amanda, Sarzotti-Kelsoe, Marcella, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Huynh, Chuong, Miller, Jacqueline, El Sahly, Hana M., Baden, Lindsey R., Baron, Mira, De La Cruz, Luis, Gay, Cynthia, Kalams, Spyros, Kelley, Colleen F., Andrasik, Michele P., Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Carpp, Lindsay N., Pajon, Rolando, Follmann, Dean, Donis, Ruben O., Koup, Richard A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Association for the Advancement of Science 2021
Materias:
Research Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9017870/
https://www.ncbi.nlm.nih.gov/pubmed/34812653
http://dx.doi.org/10.1126/science.abm3425
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author Gilbert, Peter B.
Montefiori, David C.
McDermott, Adrian B.
Fong, Youyi
Benkeser, David
Deng, Weiping
Zhou, Honghong
Houchens, Christopher R.
Martins, Karen
Jayashankar, Lakshmi
Castellino, Flora
Flach, Britta
Lin, Bob C.
O’Connell, Sarah
McDanal, Charlene
Eaton, Amanda
Sarzotti-Kelsoe, Marcella
Lu, Yiwen
Yu, Chenchen
Borate, Bhavesh
van der Laan, Lars W. P.
Hejazi, Nima S.
Huynh, Chuong
Miller, Jacqueline
El Sahly, Hana M.
Baden, Lindsey R.
Baron, Mira
De La Cruz, Luis
Gay, Cynthia
Kalams, Spyros
Kelley, Colleen F.
Andrasik, Michele P.
Kublin, James G.
Corey, Lawrence
Neuzil, Kathleen M.
Carpp, Lindsay N.
Pajon, Rolando
Follmann, Dean
Donis, Ruben O.
Koup, Richard A.
author_facet Gilbert, Peter B.
Montefiori, David C.
McDermott, Adrian B.
Fong, Youyi
Benkeser, David
Deng, Weiping
Zhou, Honghong
Houchens, Christopher R.
Martins, Karen
Jayashankar, Lakshmi
Castellino, Flora
Flach, Britta
Lin, Bob C.
O’Connell, Sarah
McDanal, Charlene
Eaton, Amanda
Sarzotti-Kelsoe, Marcella
Lu, Yiwen
Yu, Chenchen
Borate, Bhavesh
van der Laan, Lars W. P.
Hejazi, Nima S.
Huynh, Chuong
Miller, Jacqueline
El Sahly, Hana M.
Baden, Lindsey R.
Baron, Mira
De La Cruz, Luis
Gay, Cynthia
Kalams, Spyros
Kelley, Colleen F.
Andrasik, Michele P.
Kublin, James G.
Corey, Lawrence
Neuzil, Kathleen M.
Carpp, Lindsay N.
Pajon, Rolando
Follmann, Dean
Donis, Ruben O.
Koup, Richard A.
author_sort Gilbert, Peter B.
collection PubMed
description In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at the time of second vaccination and 4 weeks later, with values reported in standardized World Health Organization international units. All markers were inversely associated with COVID-19 risk and directly associated with vaccine efficacy. Vaccine recipients with postvaccination 50% neutralization titers 10, 100, and 1000 had estimated vaccine efficacies of 78% (95% confidence interval, 54 to 89%), 91% (87 to 94%), and 96% (94 to 98%), respectively. These results help define immune marker correlates of protection and may guide approval decisions for messenger RNA (mRNA) COVID-19 vaccines and other COVID-19 vaccines.
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spelling pubmed-90178702022-05-16 Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial Gilbert, Peter B. Montefiori, David C. McDermott, Adrian B. Fong, Youyi Benkeser, David Deng, Weiping Zhou, Honghong Houchens, Christopher R. Martins, Karen Jayashankar, Lakshmi Castellino, Flora Flach, Britta Lin, Bob C. O’Connell, Sarah McDanal, Charlene Eaton, Amanda Sarzotti-Kelsoe, Marcella Lu, Yiwen Yu, Chenchen Borate, Bhavesh van der Laan, Lars W. P. Hejazi, Nima S. Huynh, Chuong Miller, Jacqueline El Sahly, Hana M. Baden, Lindsey R. Baron, Mira De La Cruz, Luis Gay, Cynthia Kalams, Spyros Kelley, Colleen F. Andrasik, Michele P. Kublin, James G. Corey, Lawrence Neuzil, Kathleen M. Carpp, Lindsay N. Pajon, Rolando Follmann, Dean Donis, Ruben O. Koup, Richard A. Science Research Articles In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at the time of second vaccination and 4 weeks later, with values reported in standardized World Health Organization international units. All markers were inversely associated with COVID-19 risk and directly associated with vaccine efficacy. Vaccine recipients with postvaccination 50% neutralization titers 10, 100, and 1000 had estimated vaccine efficacies of 78% (95% confidence interval, 54 to 89%), 91% (87 to 94%), and 96% (94 to 98%), respectively. These results help define immune marker correlates of protection and may guide approval decisions for messenger RNA (mRNA) COVID-19 vaccines and other COVID-19 vaccines. American Association for the Advancement of Science 2021-11-23 2022-01-07 /pmc/articles/PMC9017870/ /pubmed/34812653 http://dx.doi.org/10.1126/science.abm3425 Text en Copyright © 2022 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works. Distributed under a Creative Commons Attribution License 4.0 (CC BY). https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution license (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Articles
Gilbert, Peter B.
Montefiori, David C.
McDermott, Adrian B.
Fong, Youyi
Benkeser, David
Deng, Weiping
Zhou, Honghong
Houchens, Christopher R.
Martins, Karen
Jayashankar, Lakshmi
Castellino, Flora
Flach, Britta
Lin, Bob C.
O’Connell, Sarah
McDanal, Charlene
Eaton, Amanda
Sarzotti-Kelsoe, Marcella
Lu, Yiwen
Yu, Chenchen
Borate, Bhavesh
van der Laan, Lars W. P.
Hejazi, Nima S.
Huynh, Chuong
Miller, Jacqueline
El Sahly, Hana M.
Baden, Lindsey R.
Baron, Mira
De La Cruz, Luis
Gay, Cynthia
Kalams, Spyros
Kelley, Colleen F.
Andrasik, Michele P.
Kublin, James G.
Corey, Lawrence
Neuzil, Kathleen M.
Carpp, Lindsay N.
Pajon, Rolando
Follmann, Dean
Donis, Ruben O.
Koup, Richard A.
Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial
title Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial
title_full Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial
title_fullStr Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial
title_full_unstemmed Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial
title_short Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial
title_sort immune correlates analysis of the mrna-1273 covid-19 vaccine efficacy clinical trial
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9017870/
https://www.ncbi.nlm.nih.gov/pubmed/34812653
http://dx.doi.org/10.1126/science.abm3425
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