CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
ID93 + GLA-SE +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/NCT02465216
NCT02465216Phase 2Completed
CompareCT.gov

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in HIV Uninfected Adult TB Patients After Treatment Completion

Access to Advanced Health Institute (AAHI)·interventional·Posted Jun 8, 2015·Updated Mar 12, 2019

In Brief

A Phase 2 clinical trial evaluating Placebo and ID93 + GLA-SE for Pulmonary Tuberculosis. Completed, enrolled 60 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful completion of TB treatment with confirmed bacteriologic cure, in preparation for a future Phase 2b prevention of TB recurrence trial in the same population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Tuberculosis
CountriesSouth Africa
CollaboratorsWellcome Trust, South African Tuberculosis Vaccine Initiative

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 8, 2015
Enrollment StartJun 1, 2015
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.1 years ago

Interventions

Placeboother

Placebo

ID93 + GLA-SEbiological

ID93 + GLA-SE