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Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial.
Zhang, Bo; Fong, Youyi; Fintzi, Jonathan; Chu, Eric; Janes, Holly E; Kenny, Avi; Carone, Marco; Benkeser, David; van der Laan, Lars W P; Deng, Weiping; Zhou, Honghong; Wang, Xiaowei; Lu, Yiwen; Yu, Chenchen; Borate, Bhavesh; Chen, Haiyan; Reeder, Isabel; Carpp, Lindsay N; Houchens, Christopher R; Martins, Karen; Jayashankar, Lakshmi; Huynh, Chuong; Fichtenbaum, Carl J; Kalams, Spyros; Gay, Cynthia L; Andrasik, Michele P; Kublin, James G; Corey, Lawrence; Neuzil, Kathleen M; Priddy, Frances; Das, Rituparna; Girard, Bethany; El Sahly, Hana M; Baden, Lindsey R; Jones, Thomas; Donis, Ruben O; Koup, Richard A; Gilbert, Peter B; Follmann, Dean.
Afiliação
  • Zhang B; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Fong Y; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Fintzi J; Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Chu E; Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Janes HE; Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
  • Kenny A; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Carone M; Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Benkeser D; Department of Biostatistics, University of Washington, Seattle, WA, USA.
  • van der Laan LWP; Department of Biostatistics, University of Washington, Seattle, WA, USA.
  • Deng W; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
  • Zhou H; Department of Statistics, University of Washington, Seattle, WA, USA.
  • Wang X; Moderna, Inc, Cambridge, MA, USA.
  • Lu Y; Moderna, Inc, Cambridge, MA, USA.
  • Yu C; Moderna, Inc, Cambridge, MA, USA.
  • Borate B; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Chen H; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Reeder I; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Carpp LN; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Houchens CR; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Martins K; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Jayashankar L; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Huynh C; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Fichtenbaum CJ; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Kalams S; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Gay CL; Division of Infectious Diseases, Department of Medicine, University of Cincinnati, Cincinnati, OH, USA.
  • Andrasik MP; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, 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; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Neuzil KM; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Priddy F; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Das R; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.
  • Girard B; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
  • El Sahly HM; Fogarty International Center, National Institutes of Health, Bethesda, MD, USA.
  • Baden LR; Moderna, Inc, Cambridge, MA, USA.
  • Jones T; Moderna, Inc, Cambridge, MA, USA.
  • Donis RO; Moderna, Inc, Cambridge, MA, USA.
  • Koup RA; Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
  • Gilbert PB; Brigham and Women's Hospital, Boston, MA, USA.
  • Follmann D; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
Nat Commun ; 15(1): 7954, 2024 Sep 11.
Article em En | MEDLINE | ID: mdl-39261482
ABSTRACT
In the phase 3 Coronavirus Efficacy (COVE) trial (NCT04470427), post-dose two Ancestral Spike-specific binding (bAb) and neutralizing (nAb) antibodies were shown to be correlates of risk (CoR) and of protection against Ancestral-lineage COVID-19 in SARS-CoV-2 naive participants. In the SARS-CoV-2 Omicron era, Omicron subvariants with varying degrees of immune escape now dominate, seropositivity rates are high, and booster doses are administered, raising questions on whether and how these developments affect the bAb and nAb correlates. To address these questions, we assess post-boost BA.1 Spike-specific bAbs and nAbs as CoRs and as correlates of booster efficacy in COVE. For naive individuals, bAbs and nAbs inversely correlate with Omicron COVID-19 hazard ratios (HR) per 10-fold marker increase (95% confidence interval) are 0.16 (0.03, 0.79) and 0.31 (0.10, 0.96), respectively. In non-naive individuals the analogous results are similar 0.15 (0.04, 0.63) and 0.28 (0.07, 1.08). For naive individuals, three vs two-dose booster efficacy correlates with predicted nAb titer at exposure, with estimates -8% (-126%, 48%), 50% (25%, 67%), and 74% (49%, 87%), at 56, 251, and 891 Arbitrary Units/ml. These results support the continued use of antibody as a surrogate endpoint.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Imunização Secundária / Anticorpos Neutralizantes / Glicoproteína da Espícula de Coronavírus / SARS-CoV-2 / COVID-19 / Vacina de mRNA-1273 contra 2019-nCoV / Anticorpos Antivirais Idioma: En Ano de publicação: 2024 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Imunização Secundária / Anticorpos Neutralizantes / Glicoproteína da Espícula de Coronavírus / SARS-CoV-2 / COVID-19 / Vacina de mRNA-1273 contra 2019-nCoV / Anticorpos Antivirais Idioma: En Ano de publicação: 2024 Tipo de documento: Article