NCT04919239

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Archivel Farma S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-09-22
• Primary completion: 2025-06-19
• Completion: 2025-06-19
• First posted: 2021-06-09
• Last updated: 2025-12-10

Locations

2 sites across 1 country: India