A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

November 21, 2014

Primary Completion Date

June 24, 2016

Study Completion Date

October 24, 2016

Conditions
Tuberculosis
Interventions
BIOLOGICAL

H56:IC31

H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c).

BIOLOGICAL

Placebo

The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.

Trial Locations (3)

Unknown

Task Clinical Research Centre, Bellville

University of Cape Town Lung Institute, Mowbray

The Aurum Institue, Johannesburg

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Statens Serum Institut

OTHER

lead

Aeras

OTHER