NCT01011309

A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis

A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in the Treatment of Patients With Cutaneous Leishmaniasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Access to Advanced Health Institute (AAHI) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy, safety, and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis, including cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.

Detailed description

A phase 2, randomized, open-label, controlled study to evaluate the efficacy, safety, and immunogenicity of the vaccine administered three times (10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56) in the treatment of adults and adolescents with CL compared to treatment with standard chemotherapy (20 mg/kg/day sodium stibogluconate for 20 days). The proportion cured in each group will be determined using clinical criteria.

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
BIOLOGICAL	LEISH-F2 + MPL-SE	10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56
DRUG	Sodium stibogluconate	20 mg/kg/day IV daily for 20 days

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-05-01
• Completion: 2011-12-01
• First posted: 2009-11-11
• Last updated: 2013-12-11
• Results posted: 2013-11-18

Locations

1 site across 1 country: Peru