Trials / Terminated
TerminatedNCT02711735
Safety of RUTI® Vaccination in MDR-TB Patients
Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients With MDR-TB After Successful Intensive-phase Treatment.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 9 (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 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.
Detailed 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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RUTI® Therapeutic vaccine | Participants randomised to this arm will receive one single dose of RUTI® vaccine in the right/left deltoid muscle. |
| BIOLOGICAL | Matching RUTI® Placebo | Participants randomised to this arm will receive aone single dose of matching RUTI® placebo in the right / left deltoid |
Timeline
- Start date
- 2020-03-18
- Primary completion
- 2020-09-09
- Completion
- 2020-09-09
- First posted
- 2016-03-17
- Last updated
- 2022-07-05
Locations
3 sites across 1 country: Ukraine
Source: ClinicalTrials.gov record NCT02711735. Inclusion in this directory is not an endorsement.