Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)

NCT04919239 | Completed Phase 2

• 1 other identifier: RUTIP2-2019-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIb trial to evaluate efficacy of RUTI® vaccine in DS- (Drug-Sensitive) and MDR-TB (Multidrug-resistant) patients favourably responding to standard MDR-TB treatment. Time point of vaccination starts upon completion of 1 week of standard DS-TB treatment (cohort A), and another cohort of patients will be vaccinated upon completion of 1 month of standard MDR-TB treatment (cohort B). All the patients will be followed up to the end of the treatment.

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with Sputum Culture Negative

  Difference between intervention and control group

  Up to Week 2 for Cohort A and Month 1.5 for Cohort B

Secondary Outcomes (3)

• Percentage of patients with Sputum Culture Negative

  Up to Week 8 for Cohort A and Month 6 for Cohort B

• Proportion of patients with reduction of bacillary load

  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

  Up to Week 2 and 8 (Cohort A); and Months 1.5 and 6 (Cohort B)

Other Outcomes (2)

• Clinical safety parameters related to vaccination

  Through study completion, an average of 2 year

• Local tolerability

  Up to Week 8

Study Arms (2)

RUTI® arm

EXPERIMENTAL

A dose of 25 μg 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.

Biological: RUTI®

Placebo arm

PLACEBO COMPARATOR

Placebo will be given at week 1 (Cohort A-DS TB Patients) or month 1 (Cohort B-MDR TB Patients) after starting standard TB treatment.

Biological: Placebo

Interventions

RUTI® BIOLOGICAL

Participants randomised to this arm will receive one single dose of RUTI® vaccine in the right/left deltoid muscle.

RUTI® arm

Placebo BIOLOGICAL

Participants randomised to this arm will receive aone single dose of matching RUTI® placebo in the right / left deltoid muscle.

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with pulmonary DS- or MDR-TB, and managed with standard-care TB drugs accordingly;
• 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;
• Patients who have not received any anti-tubercular treatment in last 6 months
• 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;
• The patient must provide written informed consent;
• The patient must be willing and able to attend all study visits and comply with all study procedures.
• \. 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.

You may not qualify if:

• Inability to provide written informed consent;
• Women reported, or detected, or willing to be pregnant during the trial period;
• Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4
• Patients with extra-pulmonary tuberculosis
• 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;
• Presence of secondary immunodeficiency states: Organ transplantation, diabetes mellitus
• 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 cells / mm3
• Cytotoxic chemotherapy or radiation therapy within the previous 3 months;
• Blood transfusion in the last three weeks prior to the trial; 10.Patients with history of alcohol or drug abuse
• \. Documented allergy to TB vaccines, notably, to the RUTI® vaccine

Sponsors & Collaborators

• Archivel Farma S.L.: lead

Study Sites (2)

All India Institute of Medical Sciences (AIIMS)

New Delhi, 11002, India

Location

Agartala Government Medical College (AGMC)

Tripura, 799006, India

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Randeep Guleria, Prof

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 9, 2021
• Study Start: September 22, 2021
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

IN (2)