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

Safety and the Efficacy of GSK Biologicals' Candidate Adjuvanted Vaccines (287615) Containing HBsAg With Various Adjuvants to Induce Cytotoxic T Lymphocytes (CTL) in Healthy Adult Volunteers

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.

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