Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: RUTI vaccine: A dose of 25 ?g of of RUTI vaccine will be given at week 1 (Cohort A-DS TB Patients) or month 1 (Cohort B-MDR TB Patients) after starting standard TB treatment.
Control In
Sponsors
Archivel Farma SL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with pulmonary DS- or MDR-TB, and managed with standard-care TB drugs accordingly; 2. Attending a TB unit / hospital routinely diagnosed with pulmonary DS- or MDR-TB with clinical status = 6 with Bandim TB score combined with chest radiography; and microbiological criteria (MGIT sputum culture), by using rapid genetic testing, gene Xpert; 3. Patients who have not received any anti-tubercular treatment in last 6 months 4. Females and males aged = 18; - females of non-childbearing potential: at least 2 years post-menopausal or surgically sterile (e.g. tubal ligation); - females of childbearing potential (including females less than 2 years postmenopausal) must have a negative pregnancy test at enrolment and must agree to use highly effective methods of birth control (i.e. diaphragm plus spermicide or male condom plus spermicide, oral contraceptive in combination with a second method, contraceptive implant, injectable contraceptive, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in the study; - males must agree to use a double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide) while participating in the study; or the male patient or his female partner must be surgically sterile (e.g. vasectomy, tubal ligation) or the female partner must be post-menopausal; 5. The patient must provide written informed consent; 6. The patient must be willing and able to attend all study visits and comply with all study procedures. Inclusion criteria for vaccination 1. Having successfully completed 1 week or 1 month (depending on the cohort) of DS or MDR-TB treatment, respectively, fully supervised; and with beneficial initial response to therapy, evidenced by clinical response.
Exclusion criteria
Exclusion criteria: 1. Inability to provide written informed consent; 2. Women reported, or detected, or willing to be pregnant during the trial period; 3. Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4 4. Patients with extra-pulmonary tuberculosis 5. Major co-morbid conditions precluding full evaluation, i.e., HIV positive, chronic renal failure, chronic liver failure, Malignancy, patients taking any immunosuppressant drug, active lung cancer, acute coronary syndrome, heart failure exceeding NYHA class 2; 6. Presence of secondary immunodeficiency states: Organ transplantation, diabetes mellitus 7. 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 8. Cytotoxic chemotherapy or radiation therapy within the previous 3 months; 9. Blood transfusion in the last three weeks prior to the trial; 10.Patients with history of alcohol or drug abuse 11. Documented allergy to TB vaccines, notably, to the RUTI? vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with Sputum Culture Negative Difference between intervention and control groupTimepoint: Up to Week 2 for Cohort A and Month 1.5 for Cohort B | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with Sputum Culture Negative Difference between intervention and control groupTimepoint: Up to Week 8 for Cohort A and Month 6 for Cohort B;Proportion of patients with reduction of bacillary load based upon Time to detection (TTD) signal in MGIT. Difference between intervention and control group.Timepoint: Up to Week 2 and 8 (Cohort A); and Months 1.5 and 6 (Cohort B);Proportion of patients with improvement of clinical signs and symptoms based upon Bandim Tb score. Difference between intervention and control group.Timepoint: Up to Week 2 and 8 (Cohort A); and Months 1.5 and 6 (Cohort B);Immunological EndpointsTimepoint: Baseline (week 0), week 1 (prior to vaccination) & week 8 (end of intensive phase) in Cohort A and baseline (week 0), month 1.0 (prior to vaccination), month 3 & 6 (end of intensive phase) in Cohort B;Safety Endpoints Safety and tolerability (physical examination, serious adverse events (SAEs), routine laboratory, chest radiography) and local injection effects between the intervention and control group.Timepoint: Throughout the trial period ;Exploratory End Points Percentage of patients with Sputum Culture Negative Difference between intervention and control groupTimepoint: Up to Week 24 for Cohort A and Month 12 & 24 for Cohort B | — |
Countries
India
Contacts
Public ContactProf Dipendra K Mitra
All India Institute of Medical Sciences
Outcome results
None listed