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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-02-28

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Cutaneous Leishmaniasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Leish-111f + MPL-SE vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Iván D Vélez Bernal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

PECET, Medellin, Colombia

Locations

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Programa de Estudio y Control de Enfermedades Tropicales (PECET)

Medellín, , Colombia

Site Status

Countries

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Colombia

Other Identifiers

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IDRI-LCVPX-105

Identifier Type: -

Identifier Source: org_study_id