Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis

Inclusion Criteria: * Men and women aged 18 or older * Written informed consent * Laboratory confirmed pulmonary TB * Clinical symptoms compatible with pulmonary TB and/or X-ray evidence of pulmonary TB * Women of non-childbearing potential: at least 2 years post-menopausal or surgically sterile (e.g. tubal ligation) * Women of childbearing potential (including women less than 2 years past menopause) must have a negative pregnancy test at enrollment and must agree to use dual-barrier methods of contraception, intrauterine device (IUD), bilateral tubal occlusion, sexual abstinence, or vasectomized partner. * Males must agree to use a double barrier method of contraception at least 1 month after RUTI/placebo vaccination; or the male patient or his female partner must be surgically sterile or the female partner must be post-menopausal * Willing and able to attend all study visits and comply with all study procedures * Verifiable address or place of residence easy accessible to perform visits and willing to inform the research team of any change during the treatment and follow-up period Exclusion Criteria: * Unable to provide written informed consent * Women reported, or detected, or willing to be pregnant during the trial period; Men willing to conceive a child during the study or 6 months after end of treatment * Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4 * Evidence or …