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

NCT ID: NCT02153320

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-05
• Study Completion Date: 2005-10-28

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.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Blood Sampling

Intervention Type: PROCEDURE

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

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).

Group Type: EXPERIMENTAL

Blood Sampling

Intervention Type: PROCEDURE

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

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).

Group Type: EXPERIMENTAL

Blood Sampling

Intervention Type: PROCEDURE

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

Interventions

Blood Sampling

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Ghent, , Belgium

Countries

Belgium

Other Identifiers

105721

Identifier Type: -

Identifier Source: org_study_id