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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:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
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 : August 2005
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Primary Outcome Measures :
  1. Adverse events
  2. Dose-limiting toxicities: hematology and serum chemistry evaluations at Screening, Days 7, 35, 63, 84
  3. T-cell IFN-γ response to the Leish-111f protein: immunology evaluations at Days 0, 84, 168

Secondary Outcome Measures :
  1. T-cell IL-5 response to the Leish-111f protein
  2. Antibody responses to the Leish-111f protein
  3. Skin test reactivity to the Leish-111f protein at Days 84, 168

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00121862

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Programa de Estudio y Control de Enfermedades Tropicales (PECET)
Medellin, Colombia
Sponsors and Collaborators
Bill and Melinda Gates Foundation
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Study Director: Franco M Piazza, MD, MPH IDRI
Layout table for additonal information Identifier: NCT00121862    
Other Study ID Numbers: IDRI-LCVPX-201
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: May 5, 2006
Last Verified: May 2006
Keywords provided by IDRI:
Subunit Vaccine
T cell
Additional relevant MeSH terms:
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Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases