1. Immunogenicity of AS03-adjuvanted and non-adjuvanted trivalent inactivated influenza vaccines in elderly adults: A Phase 3, randomized trial and post-hoc correlate of protection analysis
- Author
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Ruiz-Palacios, Guillermo M, Leroux-Roels, Geert, Beran, Jiri, Devaster, Jeanne-Marie, Esen, Meral, Launay, Odile, McElhaney, Janet E, van Essen, Gerrit A, Benoit, Anne, Claeys, Carine, Dewé, Walthère, Durand, Christelle, Duval, Xavier, Falsey, Ann R, Feldman, Gregory, Galtier, Florence, Gervais, Pierre, Hwang, Shinn-Jang, McNeil, Shelly, Richardus, Jan Hendrik, Trofa, Andrew, Oostvogels, Lidia, Influence65 study group, Cell biology, Public Health, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán - National Institute of Medical Science and Nutrition Salvador Zubiran [Mexico], Center for Vaccinology, Ghent University Hospital, First Faculty of Medicine Charles University [Prague], GlaxoSmithKline Pharmaceuticals [Rixensart] (GSK), Institut für Tropenmedizin [Tübingen], University of Tübingen, Université Sorbonne Paris Cité (USPC), Health Sciences North Research Institute [Sudbury], University Medical Center [Utrecht], Université Catholique de Louvain = Catholic University of Louvain (UCL), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC Hôpital Bichat, Institut National de la Santé et de la Recherche Médicale (INSERM)-UFR de Médecine-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University of Rochester Medical Center (URMC), Carolina Pharmaceutical Research [Spartanburg], Biocommunication en Cardio-Métabolique (BC2M), Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CIC Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-CHU Saint-Eloi-Institut National de la Santé et de la Recherche Médicale (INSERM), National Yang Ming University (NYMU), Dalhousie University [Halifax], GGD Rotterdam-Rijnmond, GlaxoSmithKline [King of Prussia] (GSK), GlaxoSmithKline Vaccines [Wavre], UCL - SSH/LIDAM/ISBA - Institut de Statistique, Biostatistique et Sciences Actuarielles, KARLI, Mélanie, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-UFR de Médecine, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Saint Eloi (CHRU Montpellier), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)
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Male ,correlates of protection ,Attack rate ,alpha-Tocopherol ,RESPIRATORY SYNCYTIAL VIRUS ,Polysorbates ,CHILDREN ,immunogenicity ,Antibodies, Viral ,AS03 ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,vaccine ,Medicine and Health Sciences ,Immunology and Allergy ,Medicine ,Single-Blind Method ,030212 general & internal medicine ,Elderly adults ,Aged, 80 and over ,[SDV.MHEP.GEG] Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology ,Immunogenicity ,[SDV.MHEP.GEG]Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology ,Antibody titer ,Research Papers ,3. Good health ,COMMUNITY ,Titer ,Drug Combinations ,Treatment Outcome ,Influenza Vaccines ,SAFETY ,[SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,Female ,seasonal influenza ,PRIOR VACCINATION ,Squalene ,030231 tropical medicine ,Immunology ,UNITED-STATES ,03 medical and health sciences ,[SDV.IMM.VAC] Life Sciences [q-bio]/Immunology/Vaccinology ,SDG 3 - Good Health and Well-being ,PEOPLE ,Correlates of protection ,Influenza, Human ,older ,Humans ,Seroconversion ,OLDER-ADULTS ,Seasonal influenza ,Aged ,Pharmacology ,business.industry ,Influenza A Virus, H3N2 Subtype ,Hemagglutination Inhibition Tests ,EFFICACY ,Older ,Vaccines, Inactivated ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,[SDV.IMM.VAC]Life Sciences [q-bio]/Immunology/Vaccinology ,business ,Vaccine - Abstract
International audience; In this study we describe the immunogenicity results from a subset of older people (N = 5187) who participated in a Phase 3 randomized, observer-blinded trial of AS03-TIV versus TIV (Fluarix™) (ClinicalTrials.gov, NCT00753272). Participants received one dose of AS03-TIV or TIV in each study year and antibody titers against the vaccine strains were assessed using hemagglutination-inhibition (HI) assay at 21 d and 180 d post-vaccination in each vaccine group in the 2008/09 (Year 1) and 2009/10 (Year 2) influenza seasons. Manufacturing consistency of 3 lots of AS03-TIV for HI antibody responses in Year 1 was a co-primary objective. In a post-hoc analysis, a statistical regression model included 4830 subjects in whom immunogenicity and laboratory-confirmed attack rate data were available; the analysis was performed to assess HI antibody titers against A/H3N2 as a correlate of protection for laboratory-confirmed A/H3N2 influenza. AS03-TIV and TIV elicited strong HI antibody responses against each vaccine strain 21 d post-vaccination in both years. The manufacturing consistency of 3 lots of AS03-TIV was demonstrated. In both years and each vaccine group, HI antibody responses were lower for A/H1N1 than the other vaccine strains. Day 180 seroconversion rates (proportion with ≥4-fold increase in titer compared with pre-vaccination titer) in Year 1 in the AS03-TIV and TIV groups, respectively, were 87.7% and 74.1% for A/H3N2, 69.7% and 59.6% for influenza B, and 58.3% and 47.4% for A/H1N1. The post-hoc statistical model based on A/H3N2 attack rates and HI antibody titers estimated that a 4-fold increase in post-vaccination titers against A/H3N2 was associated with a 2-fold decrease in the odds of A/H3N2 infection.
- Published
- 2016
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