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

Cutaneous Leishmaniasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121862
• Other study ID #: IDRI-LCVPX-201
• 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
• 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

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

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