Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis

Phase 1

Completed

• Conditions: Leishmaniasis, Mucocutaneous

• Registration Number: NCT00111514
• Lead Sponsor: Access to Advanced Health Institute (AAHI)

Brief Summary

The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given as three injections every 28 days at each of three dose levels of Leish-111f protein, in combination with standard pentavalent antimony therapy in adult patients with mucosal leishmaniasis.

Detailed Description

Mucosal leishmaniasis is a disfiguring and possibly fatal infection. All available medical therapies require weeks of treatment and cause significant toxicity. In Peru, the standard therapy is daily intravenous (IV) pentavalent antimony (20 mg/kg/day) for 28 days. It appears that Leishmania infections can be eliminated by T helper 1 immune responses. These findings argue that a vaccine that augments mucosal leishmaniasis patients' T helper 1 responses will eliminate the infection and disease. This study is a phase 1, randomized, double-blind, placebo controlled, sequential dose-escalating trial to evaluate the safety and immunogenicity of three injections of 5, 10, or 20 μg of Leish-111f protein + 25 μg of MPL-SE adjuvant given at 4 week intervals as an adjunct to standard chemotherapy with pentavalent antimony (20 mg/kg/day for 28 days) in patients with mucosal leishmaniasis.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-05-20
• Study First Submitted QC: 2005-05-20
• Study First Posted: 2005-05-23
• Study Completion: 2006-05
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-13
• Last Update Posted: 2007-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Patients with mucosal leishmaniasis confirmed by a positive smear, in vitro culture or PCR test

Exclusion Criteria

• Mucosal leishmaniasis must not involve the vocal cords or cause respiratory distress, and there must be no evidence of other disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of dose-limiting toxicity
Adverse events

Secondary Outcome Measures

Name	Time	Method
IgG and T-cell response to Leish-111f vaccine
Leish-111f skin test reactivity
Safety of the vaccine with respect to the clinical course of mucosal leishmaniasis

Trial Locations

Locations (2)

Clínica de Leishmaniasis, Hospital Nacional Sur Este EsSalud; 🇵🇪 Cusco, Peru

Universidad Peruana Cayetano Heredia; 🇵🇪 Lima, Peru