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Clinical Trial Summary

Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIa trial to evaluate safety and immunogenicity of RUTI® vaccine in Multidrug-resistant Tuberculosis (MDR-TB) patients favourably responding to standard MDR-TB treatment. Time point of vaccination starts at 16 weeks upon start of standard MDR-TB treatment (cohort A), and if clinically safe as evaluated by an independent panel of experts (DSMB), another cohort of patients will be vaccinated at 2 weeks upon start of standard MDR-TB treatment (cohort B), All the patients will be followed up 8 weeks after vaccination.


Clinical Trial Description

Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIa trial to evaluate safety and immunogenicity of RUTI® vaccine in Multidrug-resistant Tuberculosis (MDR-TB) patients favourably responding to standard MDR-TB treatment. Time point of vaccination starts at 16 weeks upon start of standard MDR-TB treatment (cohort A), and if clinically safe as evaluated by an independent panel of experts (DSMB), another cohort of patients will be vaccinated at 2 weeks upon start of standard MDR-TB treatment (cohort B) ;


Study Design


Related Conditions & MeSH terms

  • Tuberculosis
  • Tuberculosis, Multidrug Resistant
  • Tuberculosis, Multidrug-Resistant

NCT number NCT02711735
Study type Interventional
Source Archivel Farma S.L.
Contact
Status Terminated
Phase Phase 2
Start date March 18, 2020
Completion date September 9, 2020

See also
  Status Clinical Trial Phase
Completed NCT00685360 - A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB) Phase 2
Completed NCT02816931 - Drug Concentrations in the Treatment of MDR-TB Related to Minimum Inhibitory Concentrations