NCT01484548

Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers

A Phase 1, Randomized Clinical Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of The LEISH-F3 + GLA-SE Vaccine Compared To The LEISH-F3 Protein Alone In Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (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 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.

Conditions

• Leishmaniasis

Interventions

Type	Name	Description
BIOLOGICAL	LEISH-F3 + GLA-SE	20 ug of LEISH-F3 and 2 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.
BIOLOGICAL	LEISH-F3 + GLA-SE	20 ug of LEISH-F3 and 5 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.
BIOLOGICAL	LEISH-F3 alone	20 ug of LEISH-F3 antigen alone. 3 injections at Days 0, 28, and 56.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-08-01
• Completion: 2013-05-01
• First posted: 2011-12-02
• Last updated: 2014-02-26

Locations

1 site across 1 country: United States