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

Summary

70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose (N=30) regimen, or placebo (N=10). Subjects were vaccinated on Study Days 0, 56, and 231, and followed through Study Day 259.

Timeline

Start

2011-01

Primary completion

2012-05

Completion

2013-11

Drugs

Indications