Evaluating the RUTI vaccine for treating pulmonary tuberculosis
Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of the Administration of RUTI® Immunotherapy With the Standard Treatment in Patients With Tuberculosis
This study is testing the RUTI vaccine to see if it can help people with active pulmonary tuberculosis recover faster and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Archivel Farma S.L. Industry-sponsored |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 2 sites (Godoy Cruz, Mendoza and 1 other locations) |
| Trial ID | NCT05455112 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of the RUTI vaccine in patients with active pulmonary tuberculosis. The therapeutic vaccination is designed to stimulate the immune response against both active and latent bacteria, potentially improving recovery times without contributing to drug resistance. Participants will receive either the RUTI vaccine or a placebo, and the study will monitor the impact on sputum culture conversion and overall treatment outcomes. The research builds on previous findings that indicated a favorable immune response with a specific dosage of the vaccine.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 or older with laboratory-confirmed pulmonary tuberculosis.
Not a fit: Patients with conditions that prevent them from participating in the study or those with drug-resistant tuberculosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery rates for patients with pulmonary tuberculosis and reduce the risk of drug resistance.
How similar studies have performed: Other studies have shown promising results with therapeutic vaccines for tuberculosis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Godoy Cruz, Mendoza and 1 other locations
- Hospital José Nestor Lencinas — Godoy Cruz, Mendoza, Argentina (Recruiting)
- Hospital de Clínicas Presidente Dr. Nicolás Avellaneda — San Miguel De Tucumán, Tucumán, Argentina (Recruiting)
Study contacts
- Study coordinator: Leylen Colmegna
- Email: leylen.colmegna@latresearch.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.