Clinical trial NCT02153320: Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
Official title: A Long-term Follow-up of a Phase I/II Study to Compare the Persistence and to Perform in Depth Characterisation of the Cellular and Humoral Immune Response Following Vaccinations With GSK Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Keywords: HBsAg
Persistence of the immune response
Adjuvants
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 93
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Subjects who took part in and completed study 287615 (NCT00508833).
* Written informed consent obtained from the subject.
* Healthy subjects as established by medical history before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the blood sampling, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the blood sampling.
* Administration of immunoglobulins within the three months preceding the blood sampling or planned administration during the study period.
* Pregnant or lactating female.
* Documented HIV-positive subject.

Primary outcomes:
measure: 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.
timeFrame: Week 48.
measure: 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.
timeFrame: Week 78.
measure: 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.
timeFrame: Year 4.
Secondary outcomes:
measure: Anti-HBs antibody titres as measured by ELISA.
timeFrame: Week, 48, Week 78, Year 4.
measure: Exploratory analysis of proteins and low molecular weight biomolecules in the serum using ELISA and other techniques to be defined.
timeFrame: Day 0, Day 1.
measure: Frequency of HBsAg specific memory B cells by B Cell Elispot assay.
timeFrame: Week 48, Week 78, Year 4.
measure: Frequency of HBs-specific or non specific T regulatory cells using cytokine flow cytometry and other techniques to be defined.
timeFrame: Day 0, Week 6, Week 46, Week 48.
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: