drugset / Trial / NCT05455112

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

NCT05455112 ↗

Phase 2 Completed 41 enrolled Archivel Farma S.L.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject RUTI Vaccine 25 ug Subcutaneous