Tuberculosis, PulmonaryPhase 2NCT04919239
Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)
A Phase 2 study testing RUTI® in people with Tuberculosis, Pulmonary, run by Archivel Farma S.L. at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- RUTI®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesIndia
- Study dates
- 22 Sep 2021to 19 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
- 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.
Who cannot join
- 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
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- 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
- 11. Documented allergy to TB vaccines, notably, to the RUTI® vaccine
Trial locations and contacts
2 sites in 1 country.
India2 sites
All India Institute of Medical Sciences (AIIMS)
New Delhi, 11002
Agartala Government Medical College (AGMC)
Tripura, 799006
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled, Phase IIb Clinical Trial to Investigate the Efficacy of RUTI® Therapeutic Vaccination as Adjuvant of Tuberculosis Chemotherapy
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
- Being tested
- RUTI®, Placebo
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUTI®Biological
Participants randomised to this arm will receive one single dose of RUTI® vaccine in the right/left deltoid muscle.
PlaceboBiological
Participants randomised to this arm will receive aone single dose of matching RUTI® placebo in the right / left deltoid muscle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with Sputum Culture Negative
Difference between intervention and control group
Measured: Up to Week 2 for Cohort A and Month 1.5 for Cohort B
Secondary outcomes (3)
Percentage of patients with Sputum Culture Negative
Difference between intervention and control group
Measured: Up to Week 8 for Cohort A and Month 6 for Cohort B
Proportion of patients with reduction of bacillary load
Difference between intervention and control group based upon Time to detection (TTD) signal in MGIT
Measured: 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
Difference between intervention and control group based upon Bandin
Measured: Up to Week 2 and 8 (Cohort A); and Months 1.5 and 6 (Cohort B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start22 Sep 2021
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Archivel Farma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randeep Guleria, Prof, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919239
- Sponsor's protocol ID
- RUTIP2-2019-01
- Status last verified
- Dec 2025
- First submitted
- 31 May 2021
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled, Phase IIb Clinical Trial to Investigate the Efficacy of RUTI® Therapeutic Vaccination as Adjuvant of Tuberculosis Chemotherapy
- ClinicalTrials.gov ID
- NCT04919239
- Acronym / sponsor ID
- RUTIP2-2019-01
- Conditions
- Tuberculosis, Pulmonary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Archivel Farma S.L.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUTI® arm | Experimental | Biological: RUTI®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. |
| Placebo arm | Placebo comparator | Biological: PlaceboPlacebo will be given at week 1 (Cohort A-DS TB Patients) or month 1 (Cohort B-MDR TB Patients) after starting standard TB treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
- The patient must provide written informed consent;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RUTI®Participants randomised to this arm will receive one single dose of RUTI® vaccine in the right/left deltoid muscle. | Biological | RUTI® arm |
| PlaceboParticipants randomised to this arm will receive aone single dose of matching RUTI® placebo in the right / left deltoid muscle. | Biological | Placebo arm |
Primary outcome
Percentage of patients with Sputum Culture Negative
Time frame: Up to Week 2 for Cohort A and Month 1.5 for Cohort B
Difference between intervention and control group
3 secondary outcomes
Percentage of patients with Sputum Culture Negative
Time frame: Up to Week 8 for Cohort A and Month 6 for Cohort B
Proportion of patients with reduction of bacillary load
Time frame: 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
Time frame: Up to Week 2 and 8 (Cohort A); and Months 1.5 and 6 (Cohort B)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randeep Guleria, Prof principal investigator
All India Institute of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RUTI® in people with Tuberculosis, Pulmonary, run by Archivel Farma S.L. at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with Sputum Culture Negative (time frame: Up to Week 2 for Cohort A and Month 1.5 for Cohort B). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.