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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| Published in | Science (American Association for the Advancement of Science) Vol. 375; no. 6576; pp. 43 - 50 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
The American Association for the Advancement of Science
07.01.2022
American Association for the Advancement of Science |
| Subjects | |
| Online Access | Get full text |
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| Abstract | 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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| AbstractList | Antibody levels predict vaccine efficacy
Symptomatic COVID-19 infection can be prevented by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. A “correlate of protection” is a molecular biomarker to measure how much immunity is needed to fight infection and is key for successful global immunization programs. Gilbert
et al
. determined that antibodies are the correlate of protection in vaccinated individuals enrolled in the Moderna COVE phase 3 clinical trial (see the Perspective by Openshaw). By measuring binding and neutralizing antibodies against the viral spike protein, the authors found that the levels of both antibodies correlated with the degree of vaccine efficacy. The higher the antibody level, the greater the protection afforded by the messenger RNA (mRNA) vaccine. Antibody levels that predict mRNA vaccine efficacy can therefore be used to guide vaccine regimen modifications and support regulatory approvals for a broader spectrum of the population. —PNK
SARS-CoV-2 binding and neutralizing antibodies correlate with the degree of vaccine efficacy and protection for the Moderna mRNA COVID-19 vaccine.
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. Antibody levels predict vaccine efficacySymptomatic COVID-19 infection can be prevented by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. A “correlate of protection” is a molecular biomarker to measure how much immunity is needed to fight infection and is key for successful global immunization programs. Gilbert et al. determined that antibodies are the correlate of protection in vaccinated individuals enrolled in the Moderna COVE phase 3 clinical trial (see the Perspective by Openshaw). By measuring binding and neutralizing antibodies against the viral spike protein, the authors found that the levels of both antibodies correlated with the degree of vaccine efficacy. The higher the antibody level, the greater the protection afforded by the messenger RNA (mRNA) vaccine. Antibody levels that predict mRNA vaccine efficacy can therefore be used to guide vaccine regimen modifications and support regulatory approvals for a broader spectrum of the population. —PNKIn 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. 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. Symptomatic COVID-19 infection can be prevented by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. A “correlate of protection” is a molecular biomarker to measure how much immunity is needed to fight infection and is key for successful global immunization programs. Gilbert et al . determined that antibodies are the correlate of protection in vaccinated individuals enrolled in the Moderna COVE phase 3 clinical trial (see the Perspective by Openshaw). By measuring binding and neutralizing antibodies against the viral spike protein, the authors found that the levels of both antibodies correlated with the degree of vaccine efficacy. The higher the antibody level, the greater the protection afforded by the messenger RNA (mRNA) vaccine. Antibody levels that predict mRNA vaccine efficacy can therefore be used to guide vaccine regimen modifications and support regulatory approvals for a broader spectrum of the population. —PNK SARS-CoV-2 binding and neutralizing antibodies correlate with the degree of vaccine efficacy and protection for the Moderna mRNA COVID-19 vaccine. 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. 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.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. |
| Author | Sarzotti-Kelsoe, Marcella De La Cruz, Luis Miller, Jacqueline Baden, Lindsey R Kalams, Spyros Follmann, Dean Kelley, Colleen F Houchens, Christopher R Lu, Yiwen Huynh, Chuong Castellino, Flora McDanal, Charlene Fong, Youyi Lin, Bob C Neuzil, Kathleen M Eaton, Amanda Borate, Bhavesh Koup, Richard A O'Connell, Sarah Gay, Cynthia Jayashankar, Lakshmi El Sahly, Hana M Baron, Mira Corey, Lawrence Gilbert, Peter B Carpp, Lindsay N Flach, Britta Donis, Ruben O van der Laan, Lars W P Deng, Weiping Yu, Chenchen Zhou, Honghong Hejazi, Nima S Benkeser, David McDermott, Adrian B Pajon, Rolando Martins, Karen Kublin, James G Montefiori, David C Andrasik, Michele P |
| Author_xml | – sequence: 1 givenname: Peter B orcidid: 0000-0002-2662-9427 surname: Gilbert fullname: Gilbert, Peter B organization: Department of Biostatistics, University of Washington, Seattle, WA, USA – sequence: 2 givenname: David C orcidid: 0000-0003-0856-6319 surname: Montefiori fullname: Montefiori, David C organization: Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA – sequence: 3 givenname: Adrian B orcidid: 0000-0003-0616-9117 surname: McDermott fullname: McDermott, Adrian B organization: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA – sequence: 4 givenname: Youyi surname: Fong fullname: Fong, Youyi organization: Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA – sequence: 5 givenname: David surname: Benkeser fullname: Benkeser, David organization: Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA – sequence: 6 givenname: Weiping surname: Deng fullname: Deng, Weiping organization: Moderna, Inc., Cambridge, MA, USA – sequence: 7 givenname: Honghong surname: Zhou fullname: Zhou, Honghong organization: Moderna, Inc., Cambridge, MA, USA – sequence: 8 givenname: Christopher R orcidid: 0000-0001-8125-4173 surname: Houchens fullname: Houchens, Christopher R organization: Biomedical Advanced Research and Development Authority, Washington, DC, USA – sequence: 9 givenname: Karen orcidid: 0000-0001-6536-3492 surname: Martins fullname: Martins, Karen organization: Biomedical Advanced Research and Development Authority, Washington, DC, USA – sequence: 10 givenname: Lakshmi orcidid: 0000-0003-0384-2388 surname: Jayashankar fullname: Jayashankar, Lakshmi organization: Biomedical Advanced Research and Development Authority, Washington, DC, USA – sequence: 11 givenname: Flora surname: Castellino fullname: Castellino, Flora organization: Biomedical Advanced Research and Development Authority, Washington, DC, USA – sequence: 12 givenname: Britta surname: Flach fullname: Flach, Britta organization: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA – sequence: 13 givenname: Bob C surname: Lin fullname: Lin, Bob C organization: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA – sequence: 14 givenname: Sarah surname: O'Connell fullname: O'Connell, Sarah organization: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA – sequence: 15 givenname: Charlene surname: McDanal fullname: McDanal, Charlene organization: Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA – sequence: 16 givenname: Amanda orcidid: 0000-0003-3064-2947 surname: Eaton fullname: Eaton, Amanda organization: Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA – sequence: 17 givenname: Marcella surname: Sarzotti-Kelsoe fullname: Sarzotti-Kelsoe, Marcella organization: Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA – sequence: 18 givenname: Yiwen surname: Lu fullname: Lu, Yiwen organization: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA – sequence: 19 givenname: Chenchen surname: Yu fullname: Yu, Chenchen organization: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA – sequence: 20 givenname: Bhavesh surname: Borate fullname: Borate, Bhavesh organization: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA – sequence: 21 givenname: Lars W P surname: van der Laan fullname: van der Laan, Lars W P organization: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA – sequence: 22 givenname: Nima S surname: Hejazi fullname: Hejazi, Nima S organization: Division of Biostatistics, School of Public Health, University of California Berkeley, Berkeley, CA, USA – sequence: 23 givenname: Chuong surname: Huynh fullname: Huynh, Chuong organization: Biomedical Advanced Research and Development Authority, Washington, DC, USA – sequence: 24 givenname: Jacqueline orcidid: 0000-0002-7083-2182 surname: Miller fullname: Miller, Jacqueline organization: Moderna, Inc., Cambridge, MA, USA – sequence: 25 givenname: Hana M orcidid: 0000-0003-0489-0074 surname: El Sahly fullname: El Sahly, Hana M organization: Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA – sequence: 26 givenname: Lindsey R surname: Baden fullname: Baden, Lindsey R organization: Brigham and Women's Hospital, Boston, MA, USA – sequence: 27 givenname: Mira orcidid: 0000-0001-8833-3659 surname: Baron fullname: Baron, Mira organization: Palm Beach Research Center, West Palm Beach, FL, USA – sequence: 28 givenname: Luis surname: De La Cruz fullname: De La Cruz, Luis organization: Keystone Vitalink Research, Greenville, SC, USA – sequence: 29 givenname: Cynthia surname: Gay fullname: Gay, Cynthia organization: Department of Medicine, Division of Infectious Diseases, UNC HIV Cure Center, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA – sequence: 30 givenname: Spyros surname: Kalams fullname: Kalams, Spyros organization: Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA – sequence: 31 givenname: Colleen F orcidid: 0000-0001-5611-0119 surname: Kelley fullname: Kelley, Colleen F organization: Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine and the Grady Health System, Atlanta, GA, USA – sequence: 32 givenname: Michele P orcidid: 0000-0003-1952-7825 surname: Andrasik fullname: Andrasik, Michele P organization: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA – sequence: 33 givenname: James G orcidid: 0000-0003-1279-3741 surname: Kublin fullname: Kublin, James G organization: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA – sequence: 34 givenname: Lawrence orcidid: 0000-0002-2179-2436 surname: Corey fullname: Corey, Lawrence organization: Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA – sequence: 35 givenname: Kathleen M orcidid: 0000-0001-9480-2714 surname: Neuzil fullname: Neuzil, Kathleen M organization: Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA – sequence: 36 givenname: Lindsay N orcidid: 0000-0003-0333-5925 surname: Carpp fullname: Carpp, Lindsay N organization: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA – sequence: 37 givenname: Rolando surname: Pajon fullname: Pajon, Rolando organization: Moderna, Inc., Cambridge, MA, USA – sequence: 38 givenname: Dean orcidid: 0000-0003-4073-0393 surname: Follmann fullname: Follmann, Dean organization: Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA – sequence: 39 givenname: Ruben O orcidid: 0000-0001-6137-8312 surname: Donis fullname: Donis, Ruben O organization: Biomedical Advanced Research and Development Authority, Washington, DC, USA – sequence: 40 givenname: Richard A orcidid: 0000-0002-3090-7282 surname: Koup fullname: Koup, Richard A organization: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34812653$$D View this record in MEDLINE/PubMed |
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| Copyright | 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). 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). 2022 The Authors |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 These authors contributed equally to this work. The members of the Immune Assays Team; Moderna, Inc. Team; CoVPN/COVE Team; and USG/CoVPN Biostatistics Team and their affiliations are listed in the supplementary materials. |
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| Snippet | In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for... Antibody levels predict vaccine efficacy Symptomatic COVID-19 infection can be prevented by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)... Antibody levels predict vaccine efficacySymptomatic COVID-19 infection can be prevented by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)... Symptomatic COVID-19 infection can be prevented by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. A “correlate of protection” is a... |
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| SubjectTerms | 2019-nCoV Vaccine mRNA-1273 - immunology Adolescent Adult Aged Antibodies Antibodies, Neutralizing - blood Antibodies, Neutralizing - immunology Antibodies, Viral - blood Antibodies, Viral - immunology Binding Biomarkers Clinical trials Clinical Trials, Phase III as Topic Comp/Math Confidence intervals Coronavirus Coronaviruses COVID-19 COVID-19 - prevention & control COVID-19 vaccines Female Health risks Humans Immunization Immunization Programs Immunogenicity, Vaccine Immunology Infections Male Middle Aged mRNA Neutralization Neutralizing Randomized Controlled Trials as Topic Respiratory diseases SARS-CoV-2 - immunology Sensitivity and Specificity Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Spike Glycoprotein, Coronavirus - immunology Spike protein Vaccine Efficacy Vaccines Viral diseases Young Adult |
| Title | Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial |
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