tetano
Editor, Senior Moderator
Hum Vaccin Immunother. 2016 Oct 3:0. [Epub ahead of print]
[h=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.[/h] Ruiz-Palacios GM[SUP]1[/SUP], Leroux-Roels G[SUP]2[/SUP], Beran J[SUP]3[/SUP], Devaster JM[SUP]4[/SUP], Esen M[SUP]5[/SUP], Launay O[SUP]6[/SUP], McElhaney JE[SUP]7[/SUP], van Essen GA[SUP]8[/SUP], Benoit A[SUP]9[/SUP], Claeys C[SUP]10[/SUP], Dew? W[SUP]11[/SUP], Durand C[SUP]12[/SUP], Duval X[SUP]13[/SUP], Falsey AR[SUP]14[/SUP], Feldman G[SUP]15[/SUP], Galtier F[SUP]16[/SUP], Gervais P[SUP]17[/SUP], Hwang SJ[SUP]18[/SUP], McNeil S[SUP]19[/SUP], Richardus JH[SUP]20[/SUP], Trofa A[SUP]21[/SUP], Oostvogels L[SUP]22[/SUP]; Influence 65 study group.
[h=3]Author information[/h]
[h=3]Abstract[/h] 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 days and 180 days post-vaccination in each vaccine group in the 2008/09 (Year 1) and 2009/10 (Year 2) influenza seasons. Manufacturing consistency of three 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 days post-vaccination in both years. The manufacturing consistency of three 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 four-fold increase in post-vaccination titers against A/H3N2 was associated with a two-fold decrease in the odds of A/H3N2 infection.
[h=4]KEYWORDS:[/h] AS03; Seasonal influenza; correlates of protection; immunogenicity; older; vaccine
PMID: 27690762 DOI: 10.1080/21645515.2016.1219809
[PubMed - as supplied by publisher]
[h=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.[/h] Ruiz-Palacios GM[SUP]1[/SUP], Leroux-Roels G[SUP]2[/SUP], Beran J[SUP]3[/SUP], Devaster JM[SUP]4[/SUP], Esen M[SUP]5[/SUP], Launay O[SUP]6[/SUP], McElhaney JE[SUP]7[/SUP], van Essen GA[SUP]8[/SUP], Benoit A[SUP]9[/SUP], Claeys C[SUP]10[/SUP], Dew? W[SUP]11[/SUP], Durand C[SUP]12[/SUP], Duval X[SUP]13[/SUP], Falsey AR[SUP]14[/SUP], Feldman G[SUP]15[/SUP], Galtier F[SUP]16[/SUP], Gervais P[SUP]17[/SUP], Hwang SJ[SUP]18[/SUP], McNeil S[SUP]19[/SUP], Richardus JH[SUP]20[/SUP], Trofa A[SUP]21[/SUP], Oostvogels L[SUP]22[/SUP]; Influence 65 study group.
[h=3]Author information[/h]
[h=3]Abstract[/h] 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 days and 180 days post-vaccination in each vaccine group in the 2008/09 (Year 1) and 2009/10 (Year 2) influenza seasons. Manufacturing consistency of three 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 days post-vaccination in both years. The manufacturing consistency of three 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 four-fold increase in post-vaccination titers against A/H3N2 was associated with a two-fold decrease in the odds of A/H3N2 infection.
[h=4]KEYWORDS:[/h] AS03; Seasonal influenza; correlates of protection; immunogenicity; older; vaccine
PMID: 27690762 DOI: 10.1080/21645515.2016.1219809
[PubMed - as supplied by publisher]