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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.
Hum Vaccin Immunother. 2016 12; 12(12):3043-3055.HV

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.

Authors+Show Affiliations

a Department of Infectious Diseases , Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Tlalpan, C.P. México City , México.b Centre for Vaccinology , Ghent University and Ghent University Hospital , Ghent , Belgium.c Vaccination and Travel Medicine Centre, Hradec Kralove, Czech Republic; and 2nd Faculty of Medicine , Charles University in Prague , Czech Republic.d Jeanne-Marie Devaster , MD, GSK Vaccines , Rixensart , Belgium.e Institut für Tropenmedizin , Tübingen , Germany.f Inserm, CIC 1417 and French Network of Clinical Investigation in Vaccinology (I-REIVAC), France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Cochin , CIC Cochin Pasteur, Paris , France.g HSN Volunteer Association Chair in Geriatric Research , Health Sciences North Research Institute , Sudbury , ON , Canada.h Julius Center for Health Sciences and Primary Care , University Medical Center Utrecht , Utrecht , The Netherlands.i Institute of Statistics, Biostatistics and Actuarial Sciences, Université Catholique de Louvain , Louvain-la-Neuve , Belgium.j GSK Vaccines , Wavre , Belgium.k GSK Vaccines , Rixensart , Belgium.l GSK Vaccines , Wavre , Belgium.m Hôpital Bichat Claude Bernard, GH BICHAT. Paris cedex 18, France; Inserm, CIC 007 for the French Network of Clinical Investigation in Vaccinology (REIVAC) , Paris Cedex 18, France.n University of Rochester Medical Center , Rochester General Hospital , Rochester , NY , USA.o Carolina Pharmaceutical Research , Spartanburg , South Carolina , United States.p CHRU de Montpellier, Hôpital Saint Eloi, Montpellier, France; Inserm, CIC 1001 for the French Network of Clinical Investigation in Vaccinology (REIVAC) , Montpellier , France.q Q&T Research Sherbrooke , Sherbrooke , QC , Canada.r Department of Family Medicine , Taipei Veterans General Hospital, Taipei, Taiwan; National Yang-Ming University School of Medicine , Taipei , Taiwan.s Queen Elizabeth Health Sciences Centre , Dalhousie University, PCIRN, NACI, CCfV, CAIRE, QEII HSC - VG Site Infectious Diseases , Halifax, Nova Scotia , Canada.t GGD Rotterdam-Rijnmond , Rotterdam , The Netherlands.u GSK Vaccines , King of Prussia , PA , USA.v GSK Vaccines , Wavre , Belgium.No affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27690762

Citation

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. 3043-3055.
Ruiz-Palacios GM, Leroux-Roels G, Beran J, 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. Hum Vaccin Immunother. 2016;12(12):3043-3055.
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., ... 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
Ruiz-Palacios GM, 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. Hum Vaccin Immunother. 2016;12(12):3043-3055. PubMed PMID: 27690762.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Ruiz-Palacios,Guillermo M, AU - Leroux-Roels,Geert, AU - Beran,Jiri, AU - Devaster,Jeanne-Marie, AU - Esen,Meral, AU - Launay,Odile, AU - McElhaney,Janet E, AU - van Essen,Gerrit A, AU - Benoit,Anne, AU - Claeys,Carine, AU - Dewé,Walthère, AU - Durand,Christelle, AU - Duval,Xavier, AU - Falsey,Ann R, AU - Feldman,Gregory, AU - Galtier,Florence, AU - Gervais,Pierre, AU - Hwang,Shinn-Jang, AU - McNeil,Shelly, AU - Richardus,Jan Hendrik, AU - Trofa,Andrew, AU - Oostvogels,Lidia, AU - ,, PY - 2016/10/4/pubmed PY - 2017/10/5/medline PY - 2016/10/4/entrez KW - AS03 KW - correlates of protection KW - immunogenicity KW - older KW - seasonal influenza KW - vaccine SP - 3043 EP - 3055 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 12 IS - 12 N2 - 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. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/27690762/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_ L2 - http://www.tandfonline.com/doi/full/10.1080/21645515.2016.1219809 DB - PRIME DP - Unbound Medicine ER -