Last updated: 11/07/2018 01:17:05

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

GSK study ID
105721
See study documents
Clinicaltrials.gov ID
NCT02153320
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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.

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.

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:

Anti-HBs antibody titres as measured by ELISA.

Timeframe: 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.

Timeframe: Day 0, Day 1.

Frequency of HBsAg specific memory B cells by B Cell Elispot assay.

Timeframe: 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.

Timeframe: Day 0, Week 6, Week 46, Week 48.

Interventions:
  • Procedure/surgery: Blood Sampling
    • Enrollment:
    93
    Primary completion date:
    2005-28-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Leroux-Roels G et al. (2014) Vaccine Adjuvant Systems containing monophosphoryl lipid A and QS21 induce strong humoral and cellular immune responses against hepatitis B surface antigen which persist for at least 4 years after vaccination. Vaccine. doi:10.1016/j.vaccine.2014.10.078
    Medical condition
    Hepatitis B
    Product
    SB287615
    Collaborators
    GlaxoSmithKline
    Study date(s)
    September 2005 to October 2005
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    22 - 45 years
    Accepts healthy volunteers
    Yes
    • 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).
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bruxelles, Belgium, 1200
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2005-28-10
    Actual study completion date
    2005-28-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study 105721 can be found on the GSK Clinical Study Register
    Click here
    Access to clinical trial data by researchers
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