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

Summary

This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity study in adults who have recently been successfully treated for drug-susceptible pulmonary Tuberculosis (TB). The safety and immunogenicity profile of escalating doses of AERAS-456 in HIV-negative subjects recently treated for drug-susceptible pulmonary TB will be investigated. The study will be conducted at three sites in South Africa.

Timeline

Start

2014-11-21

Primary completion

2016-06-24

Completion

2016-10-24

Publications

• Background Tait D, Diacon A, Borges AH, van Brakel E, Hokey D, Rutkowski KT, Hunt DJ, Russell M, Andersen PL, Kromann I, Ruhwald M, Churchyard G, Dawson R. Safety and Immunogenicity of the H56:IC31 Tuberculosis Vaccine Candidate in Adults Successfully Treated for Drug-Susceptible Pulmonary Tuberculosis: A Phase 1 Randomized Trial. J Infect Dis. 2024 Nov 15;230(5):1262-1270. doi: 10.1093/infdis/jiae170.

Drugs

Indications