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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
GM. Ruiz-Palacios, G. Leroux-Roels, J. Beran, JM. Devaster, M. Esen, O. Launay, JE. McElhaney, GA. van Essen, A. Benoit, C. Claeys, W. Dewé, C. Durand, X. Duval, AR. Falsey, G. Feldman, F. Galtier, P. Gervais, SJ. Hwang, S. McNeil, JH. Richardus,...
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
NLK
Free Medical Journals
od 2012 do Před 1 rokem
PubMed Central
od 2012 do Před 1 rokem
Europe PubMed Central
od 2012 do Před 1 rokem
- MeSH
- alfa-tokoferol aplikace a dávkování MeSH
- chřipka lidská prevence a kontrola virologie MeSH
- fixní kombinace léků MeSH
- inaktivované vakcíny aplikace a dávkování imunologie MeSH
- jednoduchá slepá metoda MeSH
- lidé MeSH
- polysorbáty aplikace a dávkování MeSH
- protilátky virové krev MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- skvalen aplikace a dávkování MeSH
- testy inhibice hemaglutinace MeSH
- vakcíny proti chřipce aplikace a dávkování imunologie MeSH
- virus chřipky A, podtyp H3N2 imunologie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
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.
2nd Faculty of Medicine Charles University Prague Czech Republic
Assistance Publique Hôpitaux de Paris Hôpital Cochin CIC Cochin Pasteur Paris France
b Centre for Vaccinology Ghent University and Ghent University Hospital Ghent Belgium
c Vaccination and Travel Medicine Centre Hradec Kralove Czech Republic
e Institut für Tropenmedizin Tübingen Germany
f Inserm CIC 1417 and French Network of Clinical Investigation in Vaccinology France
Inserm CIC 007 for the French Network of Clinical Investigation in Vaccinology Paris Cedex 18 France
Inserm CIC 1001 for the French Network of Clinical Investigation in Vaccinology Montpellier France
Jeanne Marie Devaster MD GSK Vaccines Rixensart Belgium
k GSK Vaccines Rixensart Belgium
m Hôpital Bichat Claude Bernard GH BICHAT Paris cedex 18 France
National Yang Ming University School of Medicine Taipei Taiwan
o Carolina Pharmaceutical Research Spartanburg South Carolina United States
p CHRU de Montpellier Hôpital Saint Eloi Montpellier France
q Q and T Research Sherbrooke Sherbrooke QC Canada
r Department of Family Medicine Taipei Veterans General Hospital Taipei Taiwan
t GGD Rotterdam Rijnmond Rotterdam The Netherlands
u GSK Vaccines King of Prussia PA USA
Université Paris Descartes Sorbonne Paris Cité Paris France
University of Rochester Medical Center Rochester General Hospital Rochester NY USA
Citace poskytuje Crossref.org
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