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

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: NCT00121849
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : May 5, 2006
Bill and Melinda Gates Foundation
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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).

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Biological: Leish-111f + MPL-SE vaccine Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Leish-111f + MPL-SE Vaccine in Montenegro Skin Test-Positive Healthy Adults
Study Start Date : August 2005
Estimated Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Primary Outcome Measures :
  1. Adverse events
  2. Dose-limiting toxicities: hematology and serum chemistries at Screening and Days 7, 35, 63, and 84

Secondary Outcome Measures :
  1. IgG and T-cell responses to the Leish-111f protein: immunological evaluations at Days 0, 84, and 168
  2. Skin test reactivity to the Leish-111f protein at Days 0, 84, and 168

Information from the National Library of Medicine

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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 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

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): NCT00121849

Programa de Estudio y Control de Enfermedades Tropicales (PECET)
Medellín, Colombia
Sponsors and Collaborators
Bill and Melinda Gates Foundation
Principal Investigator: Iván D Vélez Bernal, MD, PhD PECET, Medellin, Colombia Identifier: NCT00121849     History of Changes
Other Study ID Numbers: IDRI-LCVPX-105
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:
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Immunologic Factors
Physiological Effects of Drugs