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Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine.
Benkeser, David; Fong, Youyi; Janes, Holly E; Kelly, Elizabeth J; Hirsch, Ian; Sproule, Stephanie; Stanley, Ann Marie; Maaske, Jill; Villafana, Tonya; Houchens, Christopher R; Martins, Karen; Jayashankar, Lakshmi; Castellino, Flora; Ayala, Victor; Petropoulos, Christos J; Leith, Andrew; Haugaard, Deanne; Webb, Bill; Lu, Yiwen; Yu, Chenchen; Borate, Bhavesh; van der Laan, Lars W P; Hejazi, Nima S; Carpp, Lindsay N; Randhawa, April K; Andrasik, Michele P; Kublin, James G; Isaacs, Margaret Brewinski; Makhene, Mamodikoe; Tong, Tina; Robb, Merlin L; Corey, Lawrence; Neuzil, Kathleen M; Follmann, Dean; Hoffman, Corey; Falsey, Ann R; Sobieszczyk, Magdalena; Koup, Richard A; Donis, Ruben O; Gilbert, Peter B.
Afiliação
  • Benkeser D; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
  • Fong Y; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Janes HE; Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Kelly EJ; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Hirsch I; Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Sproule S; Translational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Stanley AM; Biometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.
  • Maaske J; Biometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Villafana T; Translational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Houchens CR; Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Martins K; Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Jayashankar L; Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
  • Castellino F; Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
  • Ayala V; Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
  • Petropoulos CJ; Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
  • Leith A; Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
  • Haugaard D; LabCorp-Monogram Biosciences, South San Francisco, CA, USA.
  • Webb B; Nexelis, Seattle, WA, USA.
  • Lu Y; Nexelis, Seattle, WA, USA.
  • Yu C; Nexelis, Seattle, WA, USA.
  • Borate B; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • van der Laan LWP; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Hejazi NS; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Carpp LN; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Randhawa AK; Department of Statistics, University of Washington, Seattle, WA, USA.
  • Andrasik MP; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Kublin JG; Department of Biostatistics, T.H. Chan School of Public Health, Harvard University, Boston, MA, USA.
  • Isaacs MB; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Makhene M; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Tong T; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Robb ML; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Corey L; Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
  • Neuzil KM; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Follmann D; Vaccine Translational Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
  • Hoffman C; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.
  • Falsey AR; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
  • Sobieszczyk M; 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.
  • Donis RO; Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Gilbert PB; Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
NPJ Vaccines ; 8(1): 36, 2023 Mar 11.
Article em En | MEDLINE | ID: mdl-36899062
ABSTRACT
In the phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine conducted in the U.S., Chile, and Peru, anti-spike binding IgG concentration (spike IgG) and pseudovirus 50% neutralizing antibody titer (nAb ID50) measured four weeks after two doses were assessed as correlates of risk and protection against PCR-confirmed symptomatic SARS-CoV-2 infection (COVID-19). These analyses of SARS-CoV-2 negative participants were based on case-cohort sampling of vaccine recipients (33 COVID-19 cases by 4 months post dose two, 463 non-cases). The adjusted hazard ratio of COVID-19 was 0.32 (95% CI 0.14, 0.76) per 10-fold increase in spike IgG concentration and 0.28 (0.10, 0.77) per 10-fold increase in nAb ID50 titer. At nAb ID50 below the limit of detection (< 2.612 IU50/ml), 10, 100, and 270 IU50/ml, vaccine efficacy was -5.8% (-651%, 75.6%), 64.9% (56.4%, 86.9%), 90.0% (55.8%, 97.6%) and 94.2% (69.4%, 99.1%). These findings provide further evidence towards defining an immune marker correlate of protection to help guide regulatory/approval decisions for COVID-19 vaccines.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies Idioma: En Revista: NPJ Vaccines Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies Idioma: En Revista: NPJ Vaccines Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos