Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given as three injections every 28 days at each of three dose levels of Leish-111f protein, in combination with standard pentavalent antimony therapy in adult patients with mucosal leishmaniasis.

Condition or disease	Intervention/treatment	Phase
Leishmaniasis, Mucocutaneous	Biological: Leish-111f + MPL-SE vaccine	Phase 1

Detailed Description:

Mucosal leishmaniasis is a disfiguring and possibly fatal infection. All available medical therapies require weeks of treatment and cause significant toxicity. In Peru, the standard therapy is daily intravenous (IV) pentavalent antimony (20 mg/kg/day) for 28 days. It appears that Leishmania infections can be eliminated by T helper 1 immune responses. These findings argue that a vaccine that augments mucosal leishmaniasis patients’ T helper 1 responses will eliminate the infection and disease. This study is a phase 1, randomized, double-blind, placebo controlled, sequential dose-escalating trial to evaluate the safety and immunogenicity of three injections of 5, 10, or 20 μg of Leish-111f protein + 25 μg of MPL-SE adjuvant given at 4 week intervals as an adjunct to standard chemotherapy with pentavalent antimony (20 mg/kg/day for 28 days) in patients with mucosal leishmaniasis.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate Safety, Tolerability, and Immunogenicity of Leish-111f + MPL-SE Vaccine in Combination With Pentavalent Antimony in Treatment of Mucosal Leishmaniasis
Study Start Date :	July 2004
Study Completion Date :	May 2006

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Occurrence of dose-limiting toxicity
2. Adverse events

Secondary Outcome Measures :

1. IgG and T-cell response to Leish-111f vaccine
2. Leish-111f skin test reactivity
3. Safety of the vaccine with respect to the clinical course of mucosal leishmaniasis

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients with mucosal leishmaniasis confirmed by a positive smear, in vitro culture or PCR test

Exclusion Criteria:

• Mucosal leishmaniasis must not involve the vocal cords or cause respiratory distress, and there must be no evidence of other disease.

Contacts and Locations

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Locations

Peru
Clínica de Leishmaniasis, Hospital Nacional Sur Este EsSalud
Cusco, Peru
Universidad Peruana Cayetano Heredia
Lima, Peru, 100

Sponsors and Collaborators

IDRI

Bill and Melinda Gates Foundation

Investigators

Principal Investigator:	Alejandro Llanos-Cuentas, MD	Universidad Peruana Cayetano Heredia
Study Director:	Franco M Piazza, MD, MPh	IDRI

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Llanos-Cuentas A, Calderón W, Cruz M, Ashman JA, Alves FP, Coler RN, Bogatzki LY, Bertholet S, Laughlin EM, Kahn SJ, Beckmann AM, Cowgill KD, Reed SG, Piazza FM. A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with sodium stibogluconate for the treatment of mucosal leishmaniasis. Vaccine. 2010 Oct 28;28(46):7427-35. doi: 10.1016/j.vaccine.2010.08.092. Epub 2010 Sep 17.

ClinicalTrials.gov Identifier:	NCT00111514 History of Changes
Other Study ID Numbers:	IDRI-LMVTC-102
First Posted:	May 23, 2005
Last Update Posted:	February 15, 2007
Last Verified:	February 2007

Keywords provided by IDRI:

Leishmaniasis; Subunit vaccine; therapeutic; T-cell; pentavalent antimony

Additional relevant MeSH terms:

Leishmaniasis; Leishmaniasis, Mucocutaneous; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Skin Diseases, Parasitic	Skin Diseases, Infectious; Skin Diseases; Leishmaniasis, Cutaneous; Vaccines; Immunologic Factors; Physiological Effects of Drugs