drugset / Trial / NCT01599897

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

NCT01599897

RandomizedSingle-groupSingle-blindPrevention

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.

Timeline

Start
2012-08
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject GLA-SE Other / unclassified 2 ug Intramuscular
Subject GLA-SE Other / unclassified 5 ug Intramuscular
Subject ID93 Protein / enzyme biologic 2 ug Intramuscular
Subject ID93 Protein / enzyme biologic 10 ug Intramuscular