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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153320
• Other study ID #: 105721
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2014
• Last updated: May 24, 2017
• Start date: September 5, 2005
• Est. completion date: October 28, 2005

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 28, 2005
• Est. primary completion date: October 28, 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Procedure:
• Blood Sampling
Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Gent

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of CD4 and CD8 T cells expressing IFN-? and/or TNF-a 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.
Primary	Frequency of CD4 and CD8 T cells expressing IFN-? and/or TNF-a 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.
Primary	Frequency of CD4 and CD8 T cells expressing IFN-? and/or TNF-a and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.		Year 4.
Secondary	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).	Week, 48, Week 78, Year 4.
Secondary	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).	Day 0, Day 1.
Secondary	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).	Week 48, Week 78, Year 4.
Secondary	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).	Day 0, Week 6, Week 46, Week 48.

External Links

•   Results for study 105721 can be found on the GSK Clinical Study Register