CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
H56ug/IC31nmol +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01865487
NCT01865487Phase 2Completed
CompareCT.gov

A Phase I/IIa Double-Blind, Randomized, Placebo-controlled Dose-Finding Study to Evaluate the Safety and Immunogenicity of AERAS-456 in HIV-Negative Adults With and Without Latent Tuberculosis Infection

Aeras·interventional·Posted May 31, 2013·Updated Dec 19, 2019

In Brief

A Phase 2 clinical trial evaluating H56ug/IC31nmol and Placebo for Latent Tuberculosis Bacteriology and Histology Unknown and Latent Tuberculosis. Completed, enrolled 98 participants across 2 sites.

Detailed Summary

This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is administered by IM injection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLatent Tuberculosis Bacteriology and Histology Unknown, Latent Tuberculosis
CountriesSouth Africa
CollaboratorsStatens Serum Institut

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 31, 2013
Enrollment StartAug 1, 2013
Primary CompletionAug 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 13.1 years ago

Interventions

H56ug/IC31nmolbiological

H56:IC31 (designated as AERAS-456 for Aeras-sponsored clinical development) 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) formulated in the Th1-stimulating IC31 adjuvant.

Placebobiological

Sterile buffer consisting of 10mM Tris and 169mM NaCl at pH 7.4