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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

(2016) HUMAN VACCINES & IMMUNOTHERAPEUTICS. 12(12). p.3043-3055
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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 (TM)) 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.
Keywords
AS03, correlates of protection, immunogenicity, older, seasonal influenza, vaccine, RESPIRATORY SYNCYTIAL VIRUS, OLDER-ADULTS, SEASONAL INFLUENZA, PRIOR VACCINATION, UNITED-STATES, EFFICACY, SAFETY, PEOPLE, COMMUNITY, CHILDREN

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MLA
Ruiz-Palacios, Guillermo M., et al. “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, vol. 12, no. 12, 2016, pp. 3043–55, doi:10.1080/21645515.2016.1219809.
APA
Ruiz-Palacios, G. M., Leroux-Roels, G., Beran, J., Devaster, J.-M., Esen, M., Launay, O., … Oostvogels, L. (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
Chicago author-date
Ruiz-Palacios, Guillermo M, Geert Leroux-Roels, Jiri Beran, Jeanne-Marie Devaster, Meral Esen, Odile Launay, Janet E McElhaney, 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): 3043–55. https://doi.org/10.1080/21645515.2016.1219809.
Chicago author-date (all authors)
Ruiz-Palacios, Guillermo M, Geert Leroux-Roels, Jiri Beran, Jeanne-Marie Devaster, Meral Esen, Odile Launay, Janet E McElhaney, Gerrit A van Essen, Anne Benoit, Carine Claeys, Walthère Dewé, Christelle Durand, Xavier Duval, Ann R Falsey, Gregory Feldman, Florence Galtier, Pierre Gervais, Shinn-Jang Hwang, Shelly McNeil, Jan Hendrik Richardus, Andrew Trofa, and Lidia Oostvogels. 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. doi:10.1080/21645515.2016.1219809.
Vancouver
1.
Ruiz-Palacios GM, Leroux-Roels G, Beran J, Devaster J-M, Esen M, Launay O, et al. 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. 2016;12(12):3043–55.
IEEE
[1]
G. M. Ruiz-Palacios et al., “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, vol. 12, no. 12, pp. 3043–3055, 2016.
@article{8528356,
  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 (TM)) 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.}},
  author       = {{Ruiz-Palacios, Guillermo M and Leroux-Roels, Geert and Beran, Jiri and Devaster, Jeanne-Marie and Esen, Meral and Launay, Odile and McElhaney, Janet E and van Essen, Gerrit A and Benoit, Anne and Claeys, Carine and Dewé, Walthère and Durand, Christelle and Duval, Xavier and Falsey, Ann R and Feldman, Gregory and Galtier, Florence and Gervais, Pierre and Hwang, Shinn-Jang and McNeil, Shelly and Richardus, Jan Hendrik and Trofa, Andrew and Oostvogels, Lidia}},
  issn         = {{2164-5515}},
  journal      = {{HUMAN VACCINES & IMMUNOTHERAPEUTICS}},
  keywords     = {{AS03,correlates of protection,immunogenicity,older,seasonal influenza,vaccine,RESPIRATORY SYNCYTIAL VIRUS,OLDER-ADULTS,SEASONAL INFLUENZA,PRIOR VACCINATION,UNITED-STATES,EFFICACY,SAFETY,PEOPLE,COMMUNITY,CHILDREN}},
  language     = {{eng}},
  number       = {{12}},
  pages        = {{3043--3055}},
  title        = {{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}},
  url          = {{http://doi.org/10.1080/21645515.2016.1219809}},
  volume       = {{12}},
  year         = {{2016}},
}

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