• Occurrence, intensity and relationship to vaccination of solicited local and general symptoms. [ Time Frame: During the 7-day follow-up period after each vaccine dose. ] [ Designated as safety issue: Yes ]
  
• Occurrence, intensity and relationship to vaccination of unsolicited symptoms. [ Time Frame: During the 30-day follow-up period after each vaccine dose. ] [ Designated as safety issue: Yes ]
  
• Occurrence and relationship to vaccination of serious adverse events. [ Time Frame: During the entire study period. ] [ Designated as safety issue: Yes ]
  
• Haematological and biochemical levels. [ Time Frame: Prior to, one day, one week and one month after each vaccination. ] [ Designated as safety issue: No ]
  

• Antigen-specific antibody titres as measured by ELISA. [ Time Frame: Prior to each vaccination and one month and one year after the last dose in all groups and in addition, approximately two years and three years after the last dose in Groups A and B. ] [ Designated as safety issue: No ]
  
• Antigen-specific CD4+/CD8+ T cells expressing cytokines by flow cytometry using ICS staining on frozen PBMCs. [ Time Frame: Prior to each vaccination and one month and one year after the last dose in all groups and in addition, approximately two years and three years after the last dose in Groups A and B. ] [ Designated as safety issue: No ]
  
• Frequency of cells expressing cytokines above cut-off. [ Time Frame: Prior to each vaccination and one month and one year after the last dose in all groups and in addition, approximately two years and three years after the last dose in Groups A and B. ] [ Designated as safety issue: No ]
  
• Concentrations of IFN-γ produced in serum samples. [ Time Frame: Prior to and one day after each vaccination. ] [ Designated as safety issue: No ]
  
• Concentrations of TNF-α produced in serum samples. [ Time Frame: Prior to, 1-2 hours and 1 day after each vaccination. ] [ Designated as safety issue: No ]
  

The study is designed to have a vaccination phase (includes screening, 2 doses of vaccine 1 month apart and follow-up until 1 month post dose 2), which will be performed in an observer blinded manner. This will be followed by 3 years of follow-up which will continue in an open manner.

No new subjects will be recruited at the follow-up phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol
• A male or female between, and including, 18 and 50 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 entering into the study.
• Subjects must have PPD negative skin reactivity (0 mm induration 48 to 72 hours after PPD skin test administration).
• Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
• Seronegative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
• No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.

Exclusion Criteria:

• History of previous exposure to experimental products containing components of the experimental vaccine.
• 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 6 months prior to the first vaccine dose.
• Any chronic drug therapy to be continued during the study period. Vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (nonsteroidal anti-inflammatory drugs e.g. aspirin, ibuprofen), and acetaminophen are allowed.
• History of documented exposure to Mycobacterium tuberculosis.
• History of prior vaccination with experimental Mycobacterium tuberculosis vaccines.
• Administration of any immunoglobulins, any immunotherapy and/or any blood products within the 3 months preceding the first dose of study vaccination, or planned administrations during the study period.
• Participation in another experimental protocol during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency.
• History of hypersensitivity to vaccines or vaccine components
• 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.
• Volunteers with a personal history of autoimmune disease or who describe a first-degree relative with clearly documented autoimmune disease.
• History of any neurological disorders or seizures.
• History of chronic alcohol consumption and/or drug abuse.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects.
• Pregnant female, lactating female or female planning to become pregnant or planning to discontinue contraceptive precautions.