Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis

Summary

This is a Phase I, open-label, dose-escalation study with three study groups. This study will be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection (LTBI) and 8 of whom will not have LTBI at study enrollment. The investigational product is AERAS-456 at a dose of 15 ug of H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50 ug of H56 antigen with IC31 500 nmol KLK (50/500). The vaccine is administered by intramuscular injection.

Timeline

Start

2011-11

Primary completion

2012-12

Completion

2013-06

Publications

• Background Luabeya AK, Kagina BM, Tameris MD, Geldenhuys H, Hoff ST, Shi Z, Kromann I, Hatherill M, Mahomed H, Hanekom WA, Andersen P, Scriba TJ; H56-032 Trial Study Group; Schoeman E, Krohn C, Day CL, Africa H, Makhethe L, Smit E, Brown Y, Suliman S, Hughes EJ, Bang P, Snowden MA, McClain B, Hussey GD. First-in-human trial of the post-exposure tuberculosis vaccine H56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults. Vaccine. 2015 Aug 7;33(33):4130-40. doi: 10.1016/j.vaccine.2015.06.051. Epub 2015 Jun 19.

Drugs

Indications