Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
Condition: Tuberculosis; Healthy
MeSH terms: Tuberculosis
Intervention: MTBVAC live vaccine; Commercially available BCG live vaccine
Intervention description: Live-attenuated Mycobacterium tuberculosis vaccine; Live-attenuated Mycobacterium bovis vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential
      substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation
      in inducing protection against tuberculosis (TB). Novel vaccines are essential to fight
      against the current world epidemics in tuberculosis and resistance to anti-TB drugs.
    

Eligibility criteria:

        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.