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.

Ruiz-Palacios, Guillermo M;Leroux-Roels, Geert;Beran, Jiri;Devaster, Jeanne-Marie;Influence65 study group;et.al.
(2016) Human Vaccines & Immunotherapeutics — Vol. 12, n° 12, p. 3043-3055 (2016)

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Authors
  • Ruiz-Palacios, Guillermo M
    Author
  • Leroux-Roels, Geert
    Author
  • Beran, Jiri
    Author
  • Devaster, Jeanne-Marie
    Author
  • Benoit, AnneUCLouvain
    Author
  • Influence65 study group
    Collaborator
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Abstract
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.
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Ruiz-Palacios, G. M., Leroux-Roels, G., Beran, J., Devaster, J.-M., Esen, M., Launay, O., McElhaney, J. E., van Essen, G. A., Benoit, A., Claeys, C., Dewé, W., Durand, C., Duval, X., Falsey, A. R., Feldman, G., Galtier, F., Gervais, P., Hwang, S.-J., McNeil, S., et al. (2016). 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. Human Vaccines & Immunotherapeutics, 12(12), 3043-3055. https://doi.org/10.1080/21645515.2016.1219809 (Original work published 2016)