Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)

GlaxoSmithKline200 enrolled

Overview

This study was done to evaluate the effect of various adjuvants in combination with HBsAg as a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the various adjuvanted vaccines.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

200

Conditions

Hepatitis B Disease

Interventions

287615 containing HBsAg with adjuvantsBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers between 18 and 40 years of age * Written informed consent obtained from subject * Female of non-childbearing potential Exclusion Criteria: * Any hepatitis B vaccination. * Positive HBV serological markers: anti-HBs, anti-HBc, and/ or HBsAg * Pregnancy or lactating female * Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is the longer) preceding the first vaccine administration

Locations (1)

GSK Clinical Trials Call Center

Ghent, Belgium

Outcomes

Primary Outcomes

Intensity of the CTL response at Week 6

Secondary Outcomes

Solicited symptoms (7 days), other AEs (up to 6 mths), SAEs (entire study), intensity of CTL response at Week 46, 48, 78; anti-HBs response up to week 78

Data from ClinicalTrials.gov

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