title: Impact of adjuvants on CD4(+) T cell and B cell responses to a protein antigen vaccine: Results from a phase II, randomized, multicenter trial.
abstract: Immunogenicity and safety of different adjuvants combined with a model antigen (HBsAg) were compared. Healthy HBV-naïve adults were randomized to receive HBs adjuvanted with alum or Adjuvant Systems AS01B, AS01E, AS03A or AS04 at Days 0 and 30. Different frequencies of HBs-specific CD4+ T cells 14days post dose 2 but similar polyfunctionality profiles were induced by the different adjuvants with frequencies significantly higher in the AS01B and AS01E groups than in the other groups. Antibody concentrations 30days post-dose 2 were significantly higher in AS01B, AS01E and AS03A than in other groups. Limited correlations were observed between HBs-specific CD4+ T cell and antibody responses. Injection site pain was the most common solicited local symptom and was more frequent in AS groups than in alum group. Different adjuvants formulated with the same antigen induced different adaptive immune responses and reactogenicity patterns in healthy naïve adults. The results summary for this study (GSK study number 112115 - NCT# NCT00805389) is available on the GSK Clinical Study Register and can be accessed at www.gsk-clinicalstudyregister.com.
authors.affiliation: Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium. Electronic address: Geert.LerouxRoels@UGent.be.
authors.forename: Geert
authors.initials: G
authors.lastname: Leroux-Roels
authors.affiliation: ImmuneHealth, Gosselies, Belgium; Institute for Medical Immunology, Université Libre de Bruxelles, Gosselies, Belgium.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Marchant
authors.affiliation: ImmuneHealth, Gosselies, Belgium; CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Jack
authors.initials: J
authors.lastname: Levy
authors.affiliation: Center for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
authors.affiliation: Central Laboratory and Vaccination Center, Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Wuerzburg, Germany.
authors.forename: Tino F
authors.initials: TF
authors.lastname: Schwarz
authors.affiliation: Unité de Pharmacologie Clinique, University Hospital St-Luc, Brussels, Belgium.
authors.forename: Yves
authors.initials: Y
authors.lastname: Horsmans
authors.affiliation: Institute for Medical Microbiology and Hygiene, University of Regensburg, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Jilg
authors.affiliation: Institut für Tropenmedizin, Universitätsklinikum Tübingen, Germany.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kremsner
authors.affiliation: ImmuneHealth, Gosselies, Belgium.
authors.forename: Edwige
authors.initials: E
authors.lastname: Haelterman
authors.affiliation: Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Clément
authors.affiliation: Institut für Tropenmedizin, Universitätsklinikum Tübingen, Germany.
authors.forename: Julian J
authors.initials: JJ
authors.lastname: Gabor
authors.affiliation: Institut für Tropenmedizin, Universitätsklinikum Tübingen, Germany.
authors.forename: Meral
authors.initials: M
authors.lastname: Esen
authors.affiliation: Center for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
authors.forename: Annick
authors.initials: A
authors.lastname: Hens
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Carletti
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Laurence
authors.initials: L
authors.lastname: Fissette
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Fernanda
authors.initials: F
authors.lastname: Tavares Da Silva
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Wivine
authors.initials: W
authors.lastname: Burny
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Michel
authors.initials: M
authors.lastname: Janssens
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Philippe
authors.initials: P
authors.lastname: Moris
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Arnaud M
authors.initials: AM
authors.lastname: Didierlaurent
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Robbert
authors.initials: R
authors.lastname: Van Der Most
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Garçon
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Pascale
authors.initials: P
authors.lastname: Van Belle
authors.affiliation: GSK Vaccines, Rixensart/Wavre, Belgium.
authors.forename: Marcelle
authors.initials: M
authors.lastname: Van Mechelen
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000328:Adult; D000917:Antibody Formation / Q000276:immunology*; D001402:B-Lymphocytes / Q000276:immunology*; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008163:Luminescent Measurements; D008297:Male; D014611:Vaccination / Q000379:methods; D014612:Vaccines / Q000008:administration & dosage / Q000276:immunology*
chemical_list: D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D014612:Vaccines
keywords: Adaptive immune response; Adjuvant system; CD4(+) T cell; Hepatitis B virus surface antigen; Memory B cell; Polyfunctionality