Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis

NCT05455112 | Completed Phase 2 DMC

• 1 other identifier: CONSTAN-ARG
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

This study is proposed to evaluate the safety and efficacy of the RUTI vaccine in patients with pulmonary tuberculosis. Therapeutic vaccination of RUTI would stimulate the immune response not only against growing bacteria, but also against bacteria in a latent state that are less sensitive to antibiotic treatments. Therapeutic vaccination in patients with pulmonary tuberculosis could improve the speed of recovery of patients without inducing the appearance of drug resistance.

Conditions

Tuberculosis, Pulmonary

Keywords

Tuberculosis, immunotherapy, drug-susceptible

Outcome Measures

Primary Outcomes (3)

• Early bactericidal activity (EBA) 0-14

  Change in EBA, using the time to positivity (TTP) of sputum in liquid Mycobacteria Growth Indicator Tube (MGIT)

  From day 0 to day 14

• Adverse events

  Proportion of patients with treatment-emergent adverse events (TEAE)

  From day 0 to week 24

• Grade 3-4 adverse events

  Total number of grade 3 and 4 adverse events (AE)

  From day 0 to week 24

Secondary Outcomes (11)

• Time to sputum culture conversion (SCC)

  From day 0 to week 16

• Proportion of SCC at week 16

  From day 0 to week 16

• Proportion of SCC at week 16

  From day 0 to week 8

• Early bactericidal activity (EBA) 2-14

  From day 2 to day 14

• Early bactericidal activity (EBA) 7-14

  From day 7 to day 14

Study Arms (2)

RUTI

EXPERIMENTAL

Single injection of RUTI 25µg of FCMtb at day 0.

Biological: RUTI® Vaccine

Placebo

PLACEBO COMPARATOR

Single injection of saline at day 0.

Biological: Placebo

Interventions

Placebo BIOLOGICAL

One subcutaneous injection of saline

Placebo

RUTI® Vaccine BIOLOGICAL

One subcutaneous injection of RUTI 25µg FCMtb

RUTI

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Archivel Farma S.L.: lead

Study Sites (2)

Hospital José Nestor Lencinas

Godoy Cruz, Mendoza Province, M5547, Argentina

Location

Hospital de Clínicas Presidente Dr. Nicolás Avellaneda

San Miguel de Tucumán, Tucumán Province, T4001KKP, Argentina

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

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

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: July 8, 2022
• First Posted: July 13, 2022
• Study Start: October 29, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

AR (2)