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

Tuberculosis, Pulmonary Clinical Trial

Official title:
Double-Blind, Randomized, Placebo-Controlled, Phase IIb Clinical Trial to Investigate the Efficacy of RUTI® Therapeutic Vaccination as Adjuvant of Tuberculosis Chemotherapy

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04919239
Study type Interventional
Source Archivel Farma S.L.
Contact Dipendra K Mitra, Prof
Phone 01126588500
Email salilmitra2@gmail.com
Status Recruiting
Phase Phase 2
Start date September 22, 2021
Completion date November 2025
View Details
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