Could a vaccine speed up TB recovery?
NCT ID NCT05455112
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a therapeutic vaccine called RUTI in 41 adults with active pulmonary tuberculosis. Participants received either the vaccine or a placebo alongside their regular antibiotic treatment. The goal was to see if the vaccine could boost the immune system to kill bacteria faster and improve recovery without causing safety issues.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RUTI vaccine (a therapeutic vaccine made from fragments of tuberculosis bacteria)
- What this could lead to
- If successful, this could lead to a faster recovery from tuberculosis and reduce the risk of drug resistance.
- What could go wrong
- This is a small, early-phase trial (Phase IIb) with only 41 participants, so results may not apply to everyone. The vaccine is added to standard antibiotics, so its independent effect is unclear.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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41 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Oct 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 suspicion of resistance to rifampin, isoniazid, pyrazinamide, and ethambutol, either laboratory-confirmed or based on epidemiological history at screening * Previous treatment for M. tuberculosis in the previous 24 months. * Bodyweight \< 40kg * 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. * 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 * 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) * 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. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital José Nestor Lencinas
Godoy Cruz, Mendoza Province, M5547, Argentina
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Hospital de Clínicas Presidente Dr. Nicolás Avellaneda
San Miguel de Tucumán, Tucumán Province, T4001KKP, Argentina
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Other studies related to the condition(s) this trial covers.
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- New rapid test could free TB patients from isolation sooner