NCT01865487 - A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

November 30, 2015

Conditions

Latent Tuberculosis Bacteriology and Histology UnknownLatent Tuberculosis

Interventions

BIOLOGICAL

H56ug/IC31nmol

H56:IC31 (designated as AERAS-456 for Aeras-sponsored clinical development) 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) formulated in the Th1-stimulating IC31 adjuvant.

BIOLOGICAL

Placebo

Sterile buffer consisting of 10mM Tris and 169mM NaCl at pH 7.4

Trial Locations (2)

6850

SATVI Project Office, Brewelskloof Hospital, Worcester

7784

eKhayavac TB Vaccine Trial, Khayelitsha