NCT02375698

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

A Phase I, Double-blind, Randomized, Placebo-controlled, Study to Evaluate the Safety and Immunogenicity of AERAS-456 in HIV Negative Adults Successfully Treated for Drug-susceptible Pulmonary Tuberculosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Aeras · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be the first evaluation of AERAS-456 in subjects who have completed a full course of treatment prescribed for pulmonary TB. Subjects will begin screening for study participation when they have completed 4 calendar months of TB treatment. Subjects meeting the inclusion/exclusion criteria will be randomized within a study group in a 3:1 ratio (N=18 AERAS-456; N=6 placebo) to receive two 0.5 mL intramuscular injections of AERAS-456 or placebo eight weeks apart, on Study Day 0 and Study Day 56.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	H56:IC31	H56:IC31 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).
BIOLOGICAL	Placebo	The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.

Timeline

• Start date: 2014-11-21
• Primary completion: 2016-06-24
• Completion: 2016-10-24
• First posted: 2015-03-03
• Last updated: 2024-07-30
• Results posted: 2019-11-18

Locations

3 sites across 1 country: South Africa