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

Leishmaniasis, Mucocutaneous Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate Safety, Tolerability, and Immunogenicity of Leish-111f + MPL-SE Vaccine in Combination With Pentavalent Antimony in Treatment of Mucosal Leishmaniasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111514
• Other study ID #: IDRI-LMVTC-102
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2005
• Last updated: February 13, 2007
• Start date: July 2004
• Est. completion date: May 2006

Study information

• Verified date: February 2007
• Source: IDRI
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: General Directorate of Pharmaceuticals, Devices, and DrugsUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Mucocutaneous

Intervention

Biological:
• Leish-111f + MPL-SE vaccine

Locations

Country	Name	City	State
Peru	Clínica de Leishmaniasis, Hospital Nacional Sur Este EsSalud	Cusco
Peru	Universidad Peruana Cayetano Heredia	Lima

Sponsors (2)

Lead Sponsor	Collaborator
IDRI	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of dose-limiting toxicity
Primary	Adverse events
Secondary	IgG and T-cell response to Leish-111f vaccine
Secondary	Leish-111f skin test reactivity
Secondary	Safety of the vaccine with respect to the clinical course of mucosal leishmaniasis