drugset / Trial / NCT01484548

Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers

NCT01484548

Phase 1 Completed 36 enrolled Access to Advanced Health Institute (AAHI)
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 prophylaxis of visceral leishmaniasis. The vaccine, identified as LEISH-F3 + GLA-SE, consists of the recombinant two-antigen Leishmania recombinant protein LEISH-F3 together with the adjuvant GLA-SE.

Timeline

Start
2012-01
Primary completion
2012-08
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject GLA-SE Other / unclassified 2 ug
Subject GLA-SE Other / unclassified 5 ug
Subject LEISH-F3 Protein / enzyme biologic 20 ug