Clinical Trial to Study 4 Different Doses of the Vaccine RUTI in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Latent Tuberculosis InfectionTuberculosis
Interventions
BIOLOGICAL

RUTI

dose: 5 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28

BIOLOGICAL

RUTI

dose: 25 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28

BIOLOGICAL

RUTI

dose: 100 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28

BIOLOGICAL

RUTI

dose: 200 micrograms of FCMtb; given subcutaneously twice, on days 0 and 28

BIOLOGICAL

placebo of the vaccine RUTI

placebo of the vaccine RUTI given subcutaneously twice, on days 0 and 28

Trial Locations (3)

08916

Experimental Tuberculosis Unit. Fundació Institut per la Investigació Germans Trias i Pujol, Badalona

Hospital Germans Trias i Pujol, Badalona

Pharmacology Department. Hospital Universitari Germans Trias i Pujol., Badalona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Archivel Farma S.L.

INDUSTRY

lead

Germans Trias i Pujol Hospital

OTHER