Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y

Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 18-40 Years

This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Inclusion Criteria:

• Age: between 18 and 40 years old.
• Good physical condition as established by clinical examination and history taking at the time of entry.
• Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
• Written informed consent obtained from the subjects

Exclusion Criteria:

• Positive titres at screening for anti-hepatitis antibodies.
• Elevated serum liver enzymes
• History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
• Any acute disease at the moment of entry.
• Chronic alcohol consumption.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
• History of allergic disease likely to be stimulated by any component of the vaccine.
• Simultaneous participation in any other clinical trial.
• Previous vaccination with a hepatitis B vaccine.
• Previous vaccination with an MPL containing vaccine.
• Administration of immunoglobulins in the past 6 months and during the whole study period
• Vaccination one month before and one month after each dose of the study vaccine