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: Geert Leroux-Roels, Arnaud Marchant, Jack Levy, Pierre Van Damme, Tino F Schwarz, Yves Horsmans, Wolfgang Jilg, Peter G Kremsner, Edwige Haelterman, Frédéric Clément, Julian J Gabor, Meral Esen, Annick Hens, Isabelle Carletti, Laurence Fissette, Fernanda Tavares Da Silva, Wivine Burny, Michel Janssens, Philippe Moris, Arnaud M Didierlaurent, Robbert Van Der Most, Nathalie Garçon, Pascale Van Belle, Marcelle Van Mechelen
• Journal: Clinical immunology (Orlando, Fla.) (Clin Immunol) Vol. 169 Pg. 16-27 (08 2016) ISSN: 1521-7035 [Electronic] United States
• PMID: 27236001 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Adjuvants, Immunologic
• Hepatitis B Antibodies
• Hepatitis B Surface Antigens
• Vaccines

Topics

• Adjuvants, Immunologic (administration & dosage)
• Adult
• Antibody Formation (immunology)
• B-Lymphocytes (immunology)
• CD4-Positive T-Lymphocytes (immunology)
• Double-Blind Method
• Female
• Hepatitis B Antibodies (blood, immunology)
• Hepatitis B Surface Antigens (immunology)
• Humans
• Immunoassay (methods)
• Luminescent Measurements
• Male
• Vaccination (methods)
• Vaccines (administration & dosage, immunology)