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

NCT05455112 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-12-10

No results posted yet for this study

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

Interventions

BIOLOGICAL

RUTI® Vaccine

One subcutaneous injection of RUTI 25µg FCMtb

BIOLOGICAL

Placebo

One subcutaneous injection of saline

Sponsors & Collaborators

  • Archivel Farma S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-29
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • Argentina

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05455112 on ClinicalTrials.gov