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Study to Evaluate the Leish-111f + MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite

Primary Purpose

Cutaneous Leishmaniasis

Status

Completed

Phase

Phase 2

Locations

Colombia

Study Type

Interventional

Intervention

Leish-111f + MPL-SE vaccine

About this trial

This is an interventional prevention trial for Cutaneous Leishmaniasis focused on measuring Leishmaniasis, Subunit Vaccine, Prevention, T cell

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Must have negative Montenegro skin test (0 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 Nursing or pregnant female

Sites / Locations

Programa de Estudio y Control de Enfermedades Tropicales (PECET)

Outcomes

Primary Outcome Measures

Adverse events

Dose-limiting toxicities: hematology and serum chemistry evaluations at Screening, Days 7, 35, 63, 84

T-cell IFN-γ response to the Leish-111f protein: immunology evaluations at Days 0, 84, 168

Secondary Outcome Measures

T-cell IL-5 response to the Leish-111f protein

Antibody responses to the Leish-111f protein

Skin test reactivity to the Leish-111f protein at Days 84, 168

Full Information

NCT ID

NCT00121862

First Posted

July 18, 2005

Last Updated

May 4, 2006

Sponsor

Access to Advanced Health Institute (AAHI)

Collaborators

Bill and Melinda Gates Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00121862

Brief Title

Study to Evaluate the Leish-111f + MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite

Official Title

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Leish-111f + MPL-SE Vaccine Compared to the Leish-111f Protein Alone in Montenegro Skin Test-Negative Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

May 2006

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Access to Advanced Health Institute (AAHI)

Collaborators

Bill and Melinda Gates Foundation

4. Oversight

5. Study Description

Brief Summary

This study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in adult subjects who have no evidence of previous exposure to the Leishmania parasite.

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 2, randomized, double blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity in Montenegro skin test (MST)-negative 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). In addition, the safety and immunogenicity of the vaccine will be compared to that of the Leish-111f protein (10 μg) given alone. The vaccine, Leish-111f protein alone or placebo will be given to each study subject three times at 4 week intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cutaneous Leishmaniasis

Keywords

Leishmaniasis, Subunit Vaccine, Prevention, T cell

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Leish-111f + MPL-SE vaccine

Primary Outcome Measure Information:

Title

Adverse events

Title

Dose-limiting toxicities: hematology and serum chemistry evaluations at Screening, Days 7, 35, 63, 84

Title

T-cell IFN-γ response to the Leish-111f protein: immunology evaluations at Days 0, 84, 168

Secondary Outcome Measure Information:

Title

T-cell IL-5 response to the Leish-111f protein

Title

Antibody responses to the Leish-111f protein

Title

Skin test reactivity to the Leish-111f protein at Days 84, 168

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franco M Piazza, MD, MPH

Organizational Affiliation

Access to Advanced Health Institute (AAHI)

Official's Role

Study Director

Facility Information:

Facility Name

Programa de Estudio y Control de Enfermedades Tropicales (PECET)

City

Medellin

Country

Colombia

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Leish-111f + MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite

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