Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

• Anti-HBs antibody concentrations [ Time Frame: Months 1, 2, 3, 6, 12, 13, 42 ]
• Serious adverse experiences (SAE). [ Time Frame: Throughout the study period ]
• Occurrence and intensity of solicited local symptoms [ Time Frame: 8-day follow-up after vaccination ]
• Occurrence, intensity and relationship of solicited general symptoms [ Time Frame: 8-day follow-up after vaccination ]
• Incidence of unsolicited symptoms [ Time Frame: During the 30-day follow-up after vaccination ]

The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months

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

• Biological: Engerix™-B
  Intramuscular injection, 1 or 3 doses
• Biological: HBV-MPL vaccine
  Intramuscular injection, 1 or 3 doses

• Experimental: Group A
  Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months
  Intervention: Biological: HBV-MPL vaccine
• Experimental: Group B
  Subjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
  Interventions:

  • Biological: Engerix™-B
  • Biological: HBV-MPL vaccine
• Experimental: Group C
  Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months
  Intervention: Biological: Engerix™-B
• Experimental: Group D
  Subjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
  Interventions:

  • Biological: Engerix™-B
  • Biological: HBV-MPL vaccine
• Experimental: Group E
  Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months
  Intervention: Biological: HBV-MPL vaccine
• Experimental: Group F
  Subjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
  Interventions:

  • Biological: Engerix™-B
  • Biological: HBV-MPL vaccine
• Experimental: Group G
  Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months
  Intervention: Biological: Engerix™-B
• Experimental: Group H
  Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
  Interventions:

  • Biological: Engerix™-B
  • Biological: HBV-MPL vaccine

Inclusion Criteria:

• Between 18 and 40 years old.
• Written informed consent will have been obtained from the subjects.
• Good physical condition as established by physical examination and history taking at the time of entry.
• Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.

Exclusion Criteria:

• Positive titres for anti hepatitis B antibodies.
• Any vaccination against hepatitis B in the past.
• Elevated serum liver enzymes.
• History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
• Axillary temperature > 37°C at the time of injection.
• Any acute disease at the moment of entry.
• Chronic alcohol consumption.
• 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.
• Administration of any other vaccine(s) or any immunoglobulin during the study period.
• Simultaneous participation in any other clinical trial.