A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB

Summary

This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential. Enrollees were stratified based on time from the start of TB treatment. The "on-TB-treatment" stratum started TB treatment between 1 and 4 months (30 to 120 calendar days) prior to Study Day 0. The "post-TB-treatment" stratum started TB treatment at least 12 months (360 calendar days) prior to Study Day 0. Subjects were randomized to receive a placebo or AERAS-402 vaccine. In Dose Groups 1 and 2, subjects were randomized to receive a single injection of AERAS-402 or placebo. Dose Group 3 subjects were randomized to receive two injections on study day 0 and study day 42 of AERAS-402 or placebo.

Timeline

Start

2008-10

Primary completion

2010-07

Completion

2010-11

Publications

• van Zyl-Smit RN, Esmail A, Bateman ME, Dawson R, Goldin J, van Rikxoort E, Douoguih M, Pau MG, Sadoff JC, McClain JB, Snowden MA, Benko J, Hokey DA, Rutkowski KT, Graves A, Shepherd B, Ishmukhamedov S, Kagina BMN, Abel B, Hanekom WA, Scriba TJ, Bateman ED. Safety and Immunogenicity of Adenovirus 35 Tuberculosis Vaccine Candidate in Adults with Active or Previous Tuberculosis. A Randomized Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1171-1180. doi: 10.1164/rccm.201603-0654OC.

Drugs

Indications