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

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by:
Infectious Disease Research Institute
ClinicalTrials.gov Identifier:
NCT00121862
First received: July 18, 2005
Last updated: May 4, 2006
Last verified: May 2006
  Purpose

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 Intervention Phase
Cutaneous Leishmaniasis
Biological: Leish-111f + MPL-SE vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Infectious Disease Research Institute:

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

Estimated Enrollment: 60
Study Start Date: August 2005
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121862

Locations
Colombia
Programa de Estudio y Control de Enfermedades Tropicales (PECET)
Medellin, Colombia
Sponsors and Collaborators
Infectious Disease Research Institute
Bill and Melinda Gates Foundation
Investigators
Study Director: Franco M Piazza, MD, MPH Infectious Disease Research Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00121862     History of Changes
Other Study ID Numbers: IDRI-LCVPX-201
Study First Received: July 18, 2005
Last Updated: May 4, 2006
Health Authority: United States: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Medicamentos y Alimentos

Keywords provided by Infectious Disease Research Institute:
Leishmaniasis
Subunit Vaccine
Prevention
T cell

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014