Back to resultsStudy 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
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Blood Sampling
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring HBsAg, Persistence of the immune response, Adjuvants
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
HBsAg + adjuvant 1 Group
HBsAg + adjuvant 2 Group
HBsAg + adjuvant 3 Group
Arm Description
Single blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 1 in study 287615 (NCT00508833).
Single blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 2 in study 287615 (NCT00508833).
Single blood sample taken from subjects who had received GSK candidate vaccines containing HBsAg together with an adjuvant 3 in study 287615 (NCT00508833).
Outcomes
Primary Outcome Measures
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).
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).
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.
Secondary Outcome Measures
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).
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).
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).
Frequency of HBs-specific or non specific T regulatory cells using cytokine flow cytometry and other techniques to be defined.
The blood samples at Day 0, Week 6, Week 46 and Week 48 were taken during the primary study 287615 (NCT00508833).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02153320
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 5, 2005 (Actual)
Primary Completion Date
October 28, 2005 (Actual)
Study Completion Date
October 28, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
HBsAg, Persistence of the immune response, Adjuvants
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HBsAg + adjuvant 1 Group
Arm Type
Experimental
Arm Description
Single blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 1 in study 287615 (NCT00508833).
Arm Title
HBsAg + adjuvant 2 Group
Arm Type
Experimental
Arm Description
Single blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 2 in study 287615 (NCT00508833).
Arm Title
HBsAg + adjuvant 3 Group
Arm Type
Experimental
Arm Description
Single blood sample taken from subjects who had received GSK candidate vaccines containing HBsAg together with an adjuvant 3 in study 287615 (NCT00508833).
Intervention Type
Procedure
Intervention Name(s)
Blood Sampling
Intervention Description
Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).
Primary Outcome Measure Information:
Title
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.
Description
The blood samples at Week 48 were taken during the primary study 287615 (NCT00508833).
Time Frame
Week 48.
Title
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.
Description
The blood samples at Week 78 were taken during the primary study 287615 (NCT00508833).
Time Frame
Week 78.
Title
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 Measure Information:
Title
Anti-HBs antibody titres as measured by ELISA.
Description
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.
Title
Exploratory analysis of proteins and low molecular weight biomolecules in the serum using ELISA and other techniques to be defined.
Description
The blood samples at Day 0 and Day 1 were taken during the primary study 287615 (NCT00508833).
Time Frame
Day 0, Day 1.
Title
Frequency of HBsAg specific memory B cells by B Cell Elispot assay.
Description
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.
Title
Frequency of HBs-specific or non specific T regulatory cells using cytokine flow cytometry and other techniques to be defined.
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
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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