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

Not Applicable

• Conditions: -B552 Mucocutaneous leishmaniasis; Mucocutaneous leishmaniasis; B552

• Registration Number: PER-013-04
• Lead Sponsor: INFECTIOUS DISEASES RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-04-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Occurrence of dose-limiting toxicity<br>Measure:Occurrence of dose-limiting toxicity<br>Timepoints:throughout the study<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Response of IgG and T cells to the Leish-111f vaccine<br>Measure:Response of IgG and T cells to the Leish-111f vaccine<br>Timepoints:throughout the study<br>