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

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by:
Infectious Disease Research Institute
ClinicalTrials.gov Identifier:
NCT00121849
First received: July 15, 2005
Last updated: May 4, 2006
Last verified: May 2006
  Purpose

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 Intervention Phase
Cutaneous Leishmaniasis
Biological: Leish-111f + MPL-SE vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

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 chemistries at Screening and Days 7, 35, 63, and 84

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

Estimated Enrollment: 12
Study Start Date: August 2005
Estimated Study Completion Date: February 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 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.

  Eligibility

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

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
  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: NCT00121849

Locations
Colombia
Programa de Estudio y Control de Enfermedades Tropicales (PECET)
Medellín, Colombia
Sponsors and Collaborators
Infectious Disease Research Institute
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Iván D Vélez Bernal, MD, PhD PECET, Medellin, Colombia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00121849     History of Changes
Other Study ID Numbers: IDRI-LCVPX-105
Study First Received: July 15, 2005
Last Updated: May 4, 2006
Health Authority: United States: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia 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 July 23, 2014