The purpose of this long-term follow-up study was to evaluate the persistence of the cellular and the humoral immune response 4 years after the first dose of GSK Biologicals' investigational vaccine formulations containing HBsAg (used as a model antigen) and an adjuvant.
Subjects in this long-term follow-up study were recruited among those subjects who completed the study 287615 (NCT00508833) and who were enrolled in specific groups. All subjects were vaccinated in the study 287615 (NCT00508833) according to a 0, 1, 10 month schedule. No new subjects were enrolled and no vaccine was administered in this long-term follow-up study. There was a single visit at Year 4 at which blood samples for immunogenicity assays were taken.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
93
Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Ghent, Belgium
Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.
The blood samples at Week 48 were taken during the primary study 287615 (NCT00508833).
Time frame: Week 48.
Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.
The blood samples at Week 78 were taken during the primary study 287615 (NCT00508833).
Time frame: Week 78.
Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.
Time frame: Year 4.
Anti-HBs antibody titres as measured by ELISA.
The blood samples at Week 48 and Week 78 were taken during the primary study 287615 (NCT00508833).
Time frame: Week, 48, Week 78, Year 4.
Exploratory analysis of proteins and low molecular weight biomolecules in the serum using ELISA and other techniques to be defined.
The blood samples at Day 0 and Day 1 were taken during the primary study 287615 (NCT00508833).
Time frame: Day 0, Day 1.
Frequency of HBsAg specific memory B cells by B Cell Elispot assay.
The blood samples at Week 48 and Week 78 were taken during the primary study 287615 (NCT00508833).
Time frame: Week 48, Week 78, Year 4.
Frequency of HBs-specific or non specific T regulatory cells using cytokine flow cytometry and other techniques to be defined.
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The blood samples at Day 0, Week 6, Week 46 and Week 48 were taken during the primary study 287615 (NCT00508833).
Time frame: Day 0, Week 6, Week 46, Week 48.