MedTrace Logo

Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)

NCT04919239 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-12-10

No results posted yet for this study

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. 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

Interventions

BIOLOGICAL

RUTI®

Participants randomised to this arm will receive one single dose of RUTI® vaccine in the right/left deltoid muscle.

BIOLOGICAL

Placebo

Participants randomised to this arm will receive aone single dose of matching RUTI® placebo in the right / left deltoid muscle.

Sponsors & Collaborators

  • Archivel Farma S.L.

    lead INDUSTRY

Principal Investigators

  • Randeep Guleria, Prof · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2025-06-19
Completion
2025-06-19

Countries

  • India

Study Locations

More Related Trials

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 NCT04919239 on ClinicalTrials.gov