Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.

Inclusion Criteria

• Subjects who the Investigator believes that they can and will comply with the requirements of the protocol
• Subjects who have no evidence of exposition to BCG as demonstrated by a ELISPOT PPD assay along with no history of BCG vaccination and no BCG scar
• A male or female between, and including, 18 and 45 years of age at the time of the vaccination.
• Written informed consent obtained from the subject prior to any study procedure.
• If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception
• Clinically acceptable laboratory values for blood tests.
• Seronegative for human immunodeficiency virus 1 and -2 (HIV-1/2) antibodies, p24 antigen, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies.
• No evidence of pulmonary pathology as confirmed by chest X-ray.
• No history of extrapulmonary TB.
• No history of previous contact with M. tuberculosis (latent tuberculosis) as demonstrated by a negative ELISPOT Tb (ESAT-6, CFP10) assay.

Exclusion Criteria

• History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunisations (any vaccine).
• History of allergic disease or reactions
• History of previous administration of experimental Mycobacterium tuberculosis vaccines.
• Use of any investigational or non-registered product (drug or vaccine) in another experimental protocol other than the study vaccines within 30 days preceding the vaccination, or planned use during the study period.
• Any chronic drug therapy to be continued during the study period.
• Chronic administration of immunosuppressors or other immune-modifying drugs.
• Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the vaccination, or planned administrations during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV) based on medical history and physical examination.
• Any condition or history of any acute or chronic illness or medication which, in the opinion of the Investigator, may interfere with the evaluation of the study objectives.
• A family history of congenital or hereditary immunodeficiency.
• A stay of more than 2 months in a highly endemic area (e.g. Eastern Europe (Romania, Bulgaria) and low-income countries) within 6 months prior to the screening visit or travel of more than 2 months foreseen in an area of high endemicity after the enrolment into the study.
• History of any neurologic disorders or seizures.
• 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.