Clinical Trial to Investigate the Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI® Following One Month of Isoniazid Treatment in Subjects With Latent Tuberculosis Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Latent Tuberculosis InfectionTuberculosis
Interventions
BIOLOGICAL

RUTI

dose:5 micrograms of FCMtb (Fragmented cells of M. tuberculosis); given subcutaneously twice, on days 28 and 56.

BIOLOGICAL

RUTI

dose:25 micrograms of FCMtb (Fragmented cells of M. tuberculosis); given subcutaneously twice, on days 28 and 56.

BIOLOGICAL

RUTI

dose:50 micrograms of FCMtb (Fragmented cells of M. tuberculosis); given subcutaneously twice, on days 28 and 56.

BIOLOGICAL

RUTI Matching Placebo

Placebo of the vaccine RUTI; given subcutaneously twice, on days 28 and 56.

Trial Locations (3)

6045

Parexel Int. Port Elizabeth, Port Elizabeth

6529

Parexel Int. George, George

9301

Parexel Int. Bloemfontein, Bloemfontein

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Archivel Farma S.L.

INDUSTRY