CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
H56:IC31biological
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/NCT01967134
NCT01967134Phase 1Completed
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Phase I Open Label Dose-Escalation Study to Evaluate the Safety and Immunogenicity of H56:IC31 (AERAS-456) in HIV-negative Adults With and Without Latent Tuberculosis Infection

Aeras·interventional·Posted Oct 22, 2013·Updated Aug 21, 2019

In Brief

A Phase 1 clinical trial evaluating H56:IC31 for Latent Tuberculosis and Latent Tuberculosis Bacteriology and Histology Unknown. Completed, enrolled 25 participants across 1 site.

Detailed Summary

This is a Phase I, open-label, dose-escalation study with three study groups. This study will be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection (LTBI) and 8 of whom will not have LTBI at study enrollment. The investigational product is AERAS-456 at a dose of 15 ug of H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50 ug of H56 antigen with IC31 500 nmol KLK (50/500). The vaccine is administered by intramuscular injection.

Study Details

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

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2013
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2012
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.7 years ago

Interventions

H56:IC31biological

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) formulated in the Th1-stimulating IC31 adjuvant.