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

May 24, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Gent, Belgium, 9000
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
Time Frame: Week 78.
The blood samples at Week 78 were taken during the primary study 287615 (NCT00508833).
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.
Time Frame: Year 4.
Year 4.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
Time Frame: Day 0, Day 1.
The blood samples at Day 0 and Day 1 were taken during the primary study 287615 (NCT00508833).
Day 0, Day 1.
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).
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.
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).
Day 0, Week 6, Week 46, Week 48.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2005

Primary Completion (Actual)

October 28, 2005

Study Completion (Actual)

October 28, 2005

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105721

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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