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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2005-28-10
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
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Location
GSK Investigational Site
Gent, Belgium, 9000
Status
Study Complete
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Location
GSK Investigational Site
Bruxelles, Belgium, 1200
Status
Study Complete
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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
Completed
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

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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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