Safety Study to Evaluate the Leish-111f + MPL-SE Vaccine in the Prevention of Cutaneous Leishmaniasis in Healthy Subjects Previously Exposed to the Leishmania Parasite

Phase 1

Completed

• Conditions: Cutaneous Leishmaniasis

• Registration Number: NCT00121849
• Lead Sponsor: Access to Advanced Health Institute (AAHI)

Brief Summary

This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with a previous exposure to the Leishmania parasite (but without current or past history of leishmaniasis).

Detailed Description

Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of Leishmania disease. All available medical therapies require weeks of treatment and cause significant toxicity. It appears that Leishmania infections can be eliminated or prevented by T helper 1 immune responses. These findings argue that a vaccine that generates a T helper 1 response against the parasite will prevent the infection and disease. This is a phase 1, open-label study to evaluate the safety, tolerability and immunogenicity in Montenegro skin test (MST)-positive healthy adults of an investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis. The vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f, 10 μg) together with the adjuvant MPL-SE (25 μg). The vaccine will be given to each study subject three times at 4 week intervals.

Study Timeline

• Study First Submitted: 2005-07-15
• Study First Submitted QC: 2005-07-15
• Study First Posted: 2005-07-21
• Study Start: 2005-08
• Study Completion: 2006-02
• Status Verified: 2006-05
• Last Update Submitted: 2006-05-04
• Last Update Posted: 2006-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Must have positive Montenegro skin test (reaction >5 mm)
• Must be in good general health with normal lab values
• Negative for HIV, hepatitis B and C

Exclusion Criteria

• History of leishmaniasis or exposure to Leishmania vaccine or MPL-SE.
• Pregnant or nursing female

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse events
Dose-limiting toxicities: hematology and serum chemistries at Screening and Days 7, 35, 63, and 84

Secondary Outcome Measures

Name	Time	Method
Skin test reactivity to the Leish-111f protein at Days 0, 84, and 168
IgG and T-cell responses to the Leish-111f protein: immunological evaluations at Days 0, 84, and 168

Trial Locations

Locations (1)

Programa de Estudio y Control de Enfermedades Tropicales (PECET); 🇨🇴 Medellín, Colombia