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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.
  • Gilbert PB; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Montefiori DC; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • McDermott AB; Department of Biostatistics, University of Washington, Seattle, WA, USA.
  • Fong Y; Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
  • Benkeser D; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Deng W; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Zhou H; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Houchens CR; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
  • Martins K; Moderna, Inc., Cambridge, MA, USA.
  • Jayashankar L; Moderna, Inc., Cambridge, MA, USA.
  • Castellino F; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Flach B; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Lin BC; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • O'Connell S; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • McDanal C; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Eaton A; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Sarzotti-Kelsoe M; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Lu Y; Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
  • Yu C; Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
  • Borate B; Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
  • van der Laan LWP; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Hejazi NS; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Huynh C; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Miller J; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • El Sahly HM; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Baden LR; Division of Biostatistics, School of Public Health, University of California Berkeley, Berkeley, CA, USA.
  • Baron M; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • De La Cruz L; Moderna, Inc., Cambridge, MA, USA.
  • Gay C; Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
  • Kalams S; Brigham and Women's Hospital, Boston, MA, USA.
  • Kelley CF; Palm Beach Research Center, West Palm Beach, FL, USA.
  • Andrasik MP; Keystone Vitalink Research, Greenville, SC, USA.
  • Kublin JG; 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.
  • Corey L; Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
  • Neuzil KM; Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine and the Grady Health System, Atlanta, GA, USA.
  • Carpp LN; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Pajon R; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Follmann D; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Donis RO; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.
  • Koup RA; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Science ; 375(6576): 43-50, 2022 Jan 07.
Article in English | MEDLINE | ID: covidwho-1649486
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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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / SARS-CoV-2 / COVID-19 / Vaccine Efficacy / 2019-nCoV Vaccine mRNA-1273 / Antibodies, Viral Type of study: Diagnostic study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Science Year: 2022 Document Type: Article Affiliation country: Science.abm3425

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / SARS-CoV-2 / COVID-19 / Vaccine Efficacy / 2019-nCoV Vaccine mRNA-1273 / Antibodies, Viral Type of study: Diagnostic study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Science Year: 2022 Document Type: Article Affiliation country: Science.abm3425