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

Cutaneous Leishmaniasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121849
• Other study ID #: IDRI-LCVPX-105
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2005
• Last updated: May 4, 2006
• Start date: August 2005
• Est. completion date: February 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 Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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)	Medellín

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 chemistries at Screening and Days 7, 35, 63, and 84
Secondary	IgG and T-cell responses to the Leish-111f protein: immunological evaluations at Days 0, 84, and 168
Secondary	Skin test reactivity to the Leish-111f protein at Days 0, 84, and 168