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

Prior treatment

• Previous treatment for M. tuberculosis in the previous 24 months.
• Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study

Other illness

• Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4
• Unstable Diabetes Mellitus as a poor metabolic control within the past 12 months
• HIV-infected subjects
• Major co-morbid conditions or any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results
• HIstory of severe mental ilness which, in the opinion of the investigator, may exclude the participant from participating in the trial.
• Known allergy or any hipersensitivity to study mediactions, including rifampin, isoniazid, pyrazinamide, and ethambutol, or any of its excipients.
• Documented allergy to anti-TB vaccines or any excipient of the RUTI vaccine.

Lab values

• Evidence or suspicion of resistance to rifampin, isoniazid, pyrazinamide, and ethambutol, either laboratory-confirmed or based on epidemiological history at screening
• Any of the following laboratory parameters:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN)
  • Total bilirubin \> 2 x ULN
  • Neutrophil count ≤ 500 neutrophils / mm3
  • Platelet count \< 50,000 platelets / mm3

Other

• 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
• Bodyweight \< 40kg
• Alcohol use: potential participant either self-reports or in the investigator's opinion that the patient drinks more than an average of four units/day over a usual week or is a binge drinker (men: 5 or more drinks; women: consume 4 or more drinks, in about 2 hours)

• 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