NCT01599897

Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers

A Phase 1, Randomized, Dose-escalation Study to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine at Two Dose Levels of the ID93 Antigen and the GLA-SE Adjuvant in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Access to Advanced Health Institute (AAHI) · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis. The vaccine, identified as ID93 + GLA-SE, consists of the recombinant four-antigen Mycobacterium tuberculosis recombinant protein ID93 together with the adjuvant GLA-SE.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	ID93 + GLA-SE	ID93 antigen and GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.
BIOLOGICAL	ID93 alone	ID93 antigen alone. 3 injections and Days 0, 28, and 56.

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-05-16
• Last updated: 2017-09-15

Locations

1 site across 1 country: United States