CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
ID93 + GLA-SEbiological
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/NCT03722472
NCT03722472Phase 1Completed
CompareCT.gov

A Phase 1, Double-Blind, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Single-Vial Lyophilized ID93 + GLA-SE Vaccine Administered Intramuscularly in Healthy Adult Subjects

Access to Advanced Health Institute (AAHI)·interventional·Posted Oct 29, 2018·Updated Jun 1, 2023

In Brief

A Phase 1 clinical trial evaluating ID93 + GLA-SE for Pulmonary TB. Completed, enrolled 48 participants across 1 site.

Detailed Summary

This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM injections in healthy adult subjects (aged 18 - 55).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary TB
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedOct 29, 2018
Enrollment StartOct 2, 2018
Primary CompletionJun 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.7 years ago

Interventions

ID93 + GLA-SEbiological

The single-vial lyophilized vaccine will be reconstituted with WFI. For the two-vial presentation, the lyophilized ID93 will be reconstituted with WFI and mixed with liquid GLA-SE.