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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00121862
Other study ID # IDRI-LCVPX-201
Secondary ID
Status Completed
Phase Phase 2
First received July 18, 2005
Last updated May 4, 2006
Start date August 2005
Est. completion date March 2006

Study information

Verified date May 2006
Source IDRI
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationColombia: INVIMA Instituto Nacional de Medicamentos y Alimentos
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Biological:
Leish-111f + MPL-SE vaccine


Locations

Country Name City State
Colombia Programa de Estudio y Control de Enfermedades Tropicales (PECET) Medellin

Sponsors (2)

Lead Sponsor Collaborator
IDRI Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events
Primary Dose-limiting toxicities: hematology and serum chemistry evaluations at Screening, Days 7, 35, 63, 84
Primary T-cell IFN-? response to the Leish-111f protein: immunology evaluations at Days 0, 84, 168
Secondary T-cell IL-5 response to the Leish-111f protein
Secondary Antibody responses to the Leish-111f protein
Secondary Skin test reactivity to the Leish-111f protein at Days 84, 168
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