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

Sponsor

IDRI (Other)

Overall Status

Completed

CT.gov ID

NCT00121862

Collaborator

Bill and Melinda Gates Foundation (Other)

Enrollment

Location

Duration (Months)

8.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Leishmaniasis	Biological: Leish-111f + MPL-SE vaccine	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

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 Start Date :

Aug 1, 2005

Study Completion Date :

Mar 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Programa de Estudio y Control de Enfermedades Tropicales (PECET)	Medellin		Colombia

Sponsors and Collaborators

IDRI
Bill and Melinda Gates Foundation

Investigators

Study Director: Franco M Piazza, MD, MPH, IDRI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00121862

Other Study ID Numbers:

IDRI-LCVPX-201

First Posted:

Jul 21, 2005

Last Update Posted:

May 5, 2006

Last Verified:

May 1, 2006

Keywords provided by , ,

Additional relevant MeSH terms:

Leishmaniasis

Leishmaniasis, Cutaneous

Study Results

No Results Posted as of May 5, 2006