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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Hepatitis B

Treatments: Procedure: Blood Sampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT02153320

105721

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 22 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

HBsAg + adjuvant 1 Group

Experimental group

Description:

Single blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 1 in study 287615 (NCT00508833).

Treatment:

Procedure: Blood Sampling

HBsAg + adjuvant 2 Group

Experimental group

Description:

Single blood sample taken from subjects who had received GSK candidate vaccine containing HBsAg together with an adjuvant 2 in study 287615 (NCT00508833).

Treatment:

Procedure: Blood Sampling

HBsAg + adjuvant 3 Group

Experimental group

Description:

Single blood sample taken from subjects who had received GSK candidate vaccines containing HBsAg together with an adjuvant 3 in study 287615 (NCT00508833).

Treatment:

Procedure: Blood Sampling