Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults

• Haematological and biochemical levels in each group. [ Time Frame: At protocol defined time points ] [ Designated as safety issue: No ]
• Occurrence, intensity and relationship to vaccination of any solicited local and general symptoms in each group. [ Time Frame: During the 7-day follow-up period following vaccination after each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence, intensity and relationship to vaccination of any unsolicited symptoms in each group. [ Time Frame: During the 30-day follow-up period following vaccination after each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence and relationship to vaccination of any serious adverse events in each group. [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]

• Haematological and biochemical levels (safety and reactogenicity) [ Time Frame: At protocol defined time points ]
• Occurrence, intensity and relationship to vaccination of any solicited local and general symptoms (safety and reactogenicity) [ Time Frame: During the 7-day follow-up period following vaccination after each vaccine dose ]
• Occurrence, intensity and relationship to vaccination of any unsolicited symptoms (safety and reactogenicity) [ Time Frame: During the 30-day follow-up period following vaccination after each vaccine dose ]
• Occurrence and relationship to vaccination of any serious adverse events (safety and reactogenicity) [ Time Frame: During the entire study period ]

• Analysis of cytokines expression by M72-specific CD4+/CD8+ T cells by means of in vitro flow cytometry [ Time Frame: At protocol defined time points ] [ Designated as safety issue: No ]
• Antibody titres to M72 as measured by ELISA [ Time Frame: At protocol defined time points ] [ Designated as safety issue: No ]

• Analysis of cytokines expression by M72-specific CD4+/CD8+ T cells by means of in vitro flow cytometry using ICS(immunogenicity assessment) [ Time Frame: At protocol defined time points ]
• Antibody titres to M72 as measured by ELISA (immunogenicity assessment) [ Time Frame: At protocol defined time points ]

This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

• Biological: Control vaccine with physiological saline
  Intramuscular injection, 2 doses
• Biological: GSK Biologicals' Candidate Tuberculosis Vaccines (692342) - different formulations
  Intramuscular injection, 2 doses
• Biological: Control vaccine with the adjuvant system.
  Intramuscular injection, 2 doses

• Active Comparator: Group F
  Intervention: Biological: Control vaccine with physiological saline
• Placebo Comparator: Group C
  Intervention: Biological: Control vaccine with the adjuvant system.
• Experimental: Group E
  Intervention: Biological: GSK Biologicals' Candidate Tuberculosis Vaccines (692342) - different formulations
• Experimental: Group D
  Intervention: Biological: GSK Biologicals' Candidate Tuberculosis Vaccines (692342) - different formulations
• Experimental: Group A
  Intervention: Biological: GSK Biologicals' Candidate Tuberculosis Vaccines (692342) - different formulations
• Experimental: Group B
  Intervention: Biological: GSK Biologicals' Candidate Tuberculosis Vaccines (692342) - different formulations

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 18 and 45 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject prior to any study procedure.
• Free of obvious health problems as established by medical history and clinical examination before enrolment into the study.
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
• No evidence of pulmonary pathology as confirmed by chest X-ray.
• No history of extrapulmonary TB.
• Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and urinalysis.
• Seronegative for human immunodeficiency virus-1 and -2 (HIV-1 and -2) antibodies.
• Subjects must have a PPD positive skin reactivity 48 to 72 hours after PPD skin test administration.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies and SSRIs.
• History of previous administration of experimental Mycobacterium tuberculosis vaccines.
• History of previous exposure to experimental products containing MPL or QS21.
• Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• A family history (first generation) of congenital or hereditary immunodeficiency.
• History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
• History of any neurological disorders or seizures.
• History of allergic reactions or anaphylaxis to previous immunisations.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• History of chronic alcohol consumption and/or drug abuse.
• Major congenital defects.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.