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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

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ClinicalTrials.gov Identifier: NCT02153320
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Procedure: Blood Sampling Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : September 5, 2005
Actual Primary Completion Date : October 28, 2005
Actual Study Completion Date : October 28, 2005

Arm Intervention/treatment
Experimental: HBsAg + adjuvant 1 Group
Single blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 1 in study 287615 (NCT00508833).
Procedure: Blood Sampling
Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).

Experimental: HBsAg + adjuvant 2 Group
Single blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 2 in study 287615 (NCT00508833).
Procedure: Blood Sampling
Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).

Experimental: HBsAg + adjuvant 3 Group
Single blood sample taken from subjects who had received GSK candidate vaccines containing HBsAg together with an adjuvant 3 in study 287615 (NCT00508833).
Procedure: Blood Sampling
Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).




Primary Outcome Measures :
  1. 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: Week 48. ]
    The blood samples at Week 48 were taken during the primary study 287615 (NCT00508833).

  2. 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: Week 78. ]
    The blood samples at Week 78 were taken during the primary study 287615 (NCT00508833).

  3. 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. ]

Secondary Outcome Measures :
  1. Anti-HBs antibody titres as measured by ELISA. [ Time Frame: Week, 48, Week 78, Year 4. ]
    The blood samples at Week 48 and Week 78 were taken during the primary study 287615 (NCT00508833).

  2. Exploratory analysis of proteins and low molecular weight biomolecules in the serum using ELISA and other techniques to be defined. [ Time Frame: Day 0, Day 1. ]
    The blood samples at Day 0 and Day 1 were taken during the primary study 287615 (NCT00508833).

  3. Frequency of HBsAg specific memory B cells by B Cell Elispot assay. [ Time Frame: Week 48, Week 78, Year 4. ]
    The blood samples at Week 48 and Week 78 were taken during the primary study 287615 (NCT00508833).

  4. Frequency of HBs-specific or non specific T regulatory cells using cytokine flow cytometry and other techniques to be defined. [ Time Frame: Day 0, Week 6, Week 46, Week 48. ]
    The blood samples at Day 0, Week 6, Week 46 and Week 48 were taken during the primary study 287615 (NCT00508833).



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Ages Eligible for Study:   22 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153320


Locations
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Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02153320     History of Changes
Other Study ID Numbers: 105721
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by GlaxoSmithKline:
HBsAg
Persistence of the immune response
Adjuvants
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Vaccines
Immunologic Factors
Physiological Effects of Drugs