Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults

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 59 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject prior to any study procedure.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination,
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
• Clinically acceptable laboratory values at screening as determined by the investigator.
• No evidence of tuberculosis disease with no evidence of pulmonary pathology as confirmed by chest X-ray.
• No history of extra pulmonary tuberculosis.
• Based on their medical history, all subjects must have no history of chemotherapy for tuberculosis.

Additional inclusion criteria for subjects to be enrolled in HIV+ on highly active antiretroviral therapy cohort:

• Subjects must be HIV-positive and under care of a physician for at least 6 months.
• Subjects must have a CD4+T cell count >= 250 cells/mm3 at screening.
• Subjects must be stable on highly active antiretroviral therapy for at least 6 months, with an undetectable HIV viral load level at screening.

Additional inclusion criteria for subjects to be enrolled in HIV+ treatment naïve cohort:

• Subjects must be HIV-positive and under care of a physician for at least 6 months
• Subjects must be highly active antiretroviral therapy-naïve (never received anti-retroviral therapy after HIV diagnosis)
• Subjects must have a CD4 + T cell count above 350 cells/mm3 at screening.
• Subjects for whom commencement of highly active antiretroviral therapy is not expected based on current assessment within next year.
• Subjects must have a viral load between 5000 - 80000 copies/mL at screening.

Additional inclusion criteria for subjects to be enrolled in HIV-negative cohort

• Subjects must be negative for HIV-1.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
• History of previous administration of experimental Mtb vaccines.
• History of previous exposure to components of the investigational vaccine within 30 days preceding the first dose of study vaccine
• Chronic administration of immunosuppressant or other immune-modifying drugs within six months prior to the first vaccine/product dose. For corticosteroids, this will mean prednisone >= 20 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Any condition or illness or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
• Planned participation or participation in another experimental protocol with an experimental product during the study period.
• Administration of any immunoglobulin, 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.
• Subjects taking any of the following medication: chronic administration of systemic steroids, interleukins, systemic interferon or systemic chemotherapy.
• History of allergic reactions or anaphylaxis to any drug or vaccine.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• History of chronic alcoh