CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 84 enrolled
Drug / intervention
H4:IC31 +3 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/NCT02378207
NCT02378207Phase 1Completed
CompareCT.gov

A Randomized, Placebo-controlled, Partially Blinded Phase 1b Clinical Trial to Evaluate the Safety and Immunogenicity of BCG Revaccination, H4:IC31, and H56:IC31 in Healthy, HIV-1-Uninfected Adolescent Participants

Aeras·interventional·Posted Mar 4, 2015·Updated Nov 18, 2019

In Brief

A Phase 1 clinical trial evaluating H4:IC31, H56:IC31, and 2 other interventions for Tuberculosis. Completed, enrolled 84 participants across 1 site.

Detailed Summary

The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to provide leads for biomarkers of protection against tuberculosis. This study will complement one ongoing study (NCT02075203) evaluating the prevention of M. Tuberculosis infection using H4:IC31 (also known as AERAS-404).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesSouth Africa
CollaboratorsHIV Vaccine Trials Network, Sanofi Pasteur, a Sanofi Company, Statens Serum Institut

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 4, 2015
Enrollment StartMay 1, 2015
Primary CompletionOct 31, 2016
Study CompletionDec 9, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.3 years ago

Interventions

H4:IC31biological

H4 contains Mtb antigens Ag85B and TB10.4

H56:IC31biological

H56 contains Mtb antigens ESAT-6, and Rv2660c

BCGbiological

Control Sodium Chloride 0.9%biological