A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

May 31, 2012

Study Completion Date

November 30, 2013

Conditions
Tuberculosis
Interventions
BIOLOGICAL

BCG SSI

The dose volume administered for BCG was 0.1 mL, and the mode of administration was ID injection to the deltoid area.

BIOLOGICAL

Placebo

This is the identical buffer solution in which H4:IC31 was formulated. The dose volume administered for Placebo was 0.5mL, and the mode of administration was an IM injection.

BIOLOGICAL

AERAS-404

AERAS-404 vaccine was reconstituted on site by adding 0.2 mL H4 antigen solution to 0.8 mL IC31 adjuvant solution. The dose volume administered for AERAS-404 was 0.5mL, and the mode of administration was an IM injection.

Trial Locations (1)

Unknown

Centre Hosptialier Universitaire Vaudois (CHUV), Lausanne

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Sanofi Pasteur, a Sanofi Company

INDUSTRY

lead

Aeras

OTHER