NCT02711735View on ClinicalTrials.gov

Safety of RUTI® Vaccination in MDR-TB Patients

PHASE2TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

March 18, 2020

Primary Completion Date

September 9, 2020

Study Completion Date

September 9, 2020

Conditions
Tuberculosis, Multidrug Resistant
Interventions
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

Trial Locations (3)

58000

"Chernivtsi Regional Clinical TB Dispensary, II tuberculosis department of multidrug-resistant tuberculosis", Chernivtsi

61096

Medical Department #2 (resistant tuberculosis) of Kharkiv Regional Antituberculosis Dispensary No1, Kharkiv

76018

"Ivano-Frankivsk Regional Phthisiopulmonology Center of Ivano-Frankivsk Regional Council, Center for Pulmonary Diseases", Ivano-Frankivsk

Sponsors
All Listed Sponsors
collaborator

London School of Hygiene and Tropical Medicine

OTHER

lead

Archivel Farma S.L.

INDUSTRY