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Immune Correlates Analysis of a Single Ad26.COV2.S Dose in the ENSEMBLE COVID-19 Vaccine Efficacy Clinical Trial.
Fong, Youyi; McDermott, Adrian B; Benkeser, David; Roels, Sanne; Stieh, Daniel J; Vandebosch, An; Gars, Mathieu Le; Van Roey, Griet A; Houchens, Christopher R; Martins, Karen; Jayashankar, Lakshmi; Castellino, Flora; Amoa-Awua, Obrimpong; Basappa, Manjula; Flach, Britta; Lin, Bob C; Moore, Christopher; Naisan, Mursal; Naqvi, Muhammed; Narpala, Sandeep; O'Connell, Sarah; Mueller, Allen; Serebryannyy, Leo; Castro, Mike; Wang, Jennifer; Petropoulos, Christos J; Luedtke, Alex; Hyrien, Ollivier; Lu, Yiwen; Yu, Chenchen; Borate, Bhavesh; van der Laan, Lars W P; Hejazi, Nima S; Kenny, Avi; Carone, Marco; Wolfe, Daniel N; Sadoff, Jerald; Gray, Glenda E; Grinsztejn, Beatriz; Goepfert, Paul A; Little, Susan J; de Sousa, Leonardo Paiva; Maboa, Rebone; Randhawa, April K; Andrasik, Michele P; Hendriks, Jenny; Truyers, Carla; Struyf, Frank; Schuitemaker, Hanneke; Douoguih, Macaya.
Affiliation
  • Fong Y; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • McDermott AB; Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Benkeser D; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Roels S; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
  • Stieh DJ; Janssen R&D, a division of Janssen Pharmaceutica NV, Beerse, Belgium.
  • Vandebosch A; Janssen Vaccines and Prevention, Leiden, the Netherlands.
  • Gars ML; Janssen R&D, a division of Janssen Pharmaceutica NV, Beerse, Belgium.
  • Van Roey GA; Janssen Vaccines and Prevention, Leiden, the Netherlands.
  • Houchens CR; Janssen Vaccines and Prevention, Leiden, the Netherlands.
  • Martins K; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Jayashankar L; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Castellino F; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Amoa-Awua O; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Basappa M; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Flach B; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Lin BC; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Moore C; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Naisan M; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Naqvi M; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Narpala S; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • O'Connell S; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Mueller A; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Serebryannyy L; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Castro M; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Wang J; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Petropoulos CJ; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Luedtke A; LabCorp-Monogram Biosciences, South San Francisco, CA, USA.
  • Hyrien O; Department of Statistics, University of Washington, Seattle, WA, USA.
  • Lu Y; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Yu C; Public Health Sciences Division, Fred Hutchinson Cancer Center, 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.
  • Kenny A; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Carone M; Department of Statistics, University of Washington, Seattle, WA, USA.
  • Wolfe DN; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Sadoff J; Division of Biostatistics, School of Public Health, Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
  • Gray GE; Department of Biostatistics, University of Washington School of Public Health, Seattle, WA, USA.
  • Grinsztejn B; Department of Biostatistics, University of Washington School of Public Health, Seattle, WA, USA.
  • Goepfert PA; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Little SJ; Janssen Vaccines and Prevention, Leiden, the Netherlands.
  • de Sousa LP; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Maboa R; South African Medical Research Council, Cape Town, South Africa.
  • Randhawa AK; Evandro Chagas National Institute of Infectious Diseases-Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.
  • Andrasik MP; Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
  • Hendriks J; Division of Infectious Diseases, University of California San Diego, La Jolla, CA, USA.
  • Truyers C; Evandro Chagas National Institute of Infectious Diseases-Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.
  • Struyf F; Ndlovu Elandsdoorn Site, Limpopo, Dennilton, South Africa.
  • Schuitemaker H; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Douoguih M; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
medRxiv ; 2022 Apr 12.
Article in En | MEDLINE | ID: mdl-35441174
ABSTRACT
Anti-spike IgG binding antibody, anti-receptor binding domain IgG antibody, and pseudovirus neutralizing antibody measurements four weeks post-vaccination were assessed as correlates of risk of moderate to severe-critical COVID-19 outcomes through 83 days post-vaccination and as correlates of protection following a single dose of Ad26.COV2.S COVID-19 vaccine in the placebo-controlled phase of ENSEMBLE, an international, randomized efficacy trial. Each marker had evidence as a correlate of risk and of protection, with strongest evidence for 50% inhibitory dilution (ID50) neutralizing antibody titer. The outcome hazard ratio was 0.49 (95% confidence interval 0.29, 0.81; p=0.006) per 10-fold increase in ID50; vaccine efficacy was 60% (43, 72%) at nonquantifiable ID50 (< 2.7 IU50/ml) and rose to 89% (78, 96%) at ID50 = 96.3 IU50/ml. Comparison of the vaccine efficacy by ID50 titer curves for ENSEMBLE-US, the COVE trial of the mRNA-1273 vaccine, and the COV002-UK trial of the AZD1222 vaccine supported consistency of the ID50 titer correlate of protection across trials and vaccine types.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials Language: En Journal: MedRxiv Year: 2022 Document type: Article Affiliation country: United States
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials Language: En Journal: MedRxiv Year: 2022 Document type: Article Affiliation country: United States