NCT02153320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2005

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

May 22, 2014

Last Update Submit

May 24, 2017

Conditions

Hepatitis B

Keywords

HBsAgPersistence of the immune responseAdjuvants

Outcome Measures

Primary Outcomes (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.

    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.

    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.

    Year 4.

Secondary Outcomes (4)

  • Anti-HBs antibody titres as measured by ELISA.

    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.

    Day 0, Day 1.

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

    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.

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

Study Arms (3)

HBsAg + adjuvant 1 Group

EXPERIMENTAL

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

HBsAg + adjuvant 2 Group

EXPERIMENTAL

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

HBsAg + adjuvant 3 Group

EXPERIMENTAL

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

Interventions

Blood SamplingPROCEDURE

Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).

HBsAg + adjuvant 1 GroupHBsAg + adjuvant 2 GroupHBsAg + adjuvant 3 Group

Eligibility Criteria

Age22 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Hepatitis B

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2014

First Posted

June 3, 2014

Study Start

September 5, 2005

Primary Completion

October 28, 2005

Study Completion

October 28, 2005

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

BE(2)