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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00121862
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : May 5, 2006
Bill and Melinda Gates Foundation
Information provided by:

July 18, 2005
July 21, 2005
May 5, 2006
August 2005
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  • 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
Same as current
Complete list of historical versions of study NCT00121862 on Archive Site
  • 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
Same as current
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Study to Evaluate the Leish-111f + MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite
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
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Cutaneous Leishmaniasis
Biological: Leish-111f + MPL-SE vaccine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2006
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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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Bill and Melinda Gates Foundation
Study Director: Franco M Piazza, MD, MPH IDRI
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP