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

Purpose

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	Intervention	Phase
Leishmaniasis, Mucocutaneous	Biological: Leish-111f + MPL-SE vaccine	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis

Genetic and Rare Diseases Information Center resources: Leishmaniasis

U.S. FDA Resources

Further study details as provided by IDRI:

Primary Outcome Measures:

Occurrence of dose-limiting toxicity
Adverse events

Secondary Outcome Measures:

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


Estimated Enrollment:	48
Study Start Date:	July 2004
Estimated Study Completion Date:	May 2006

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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111514

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

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
Study First Received:	May 20, 2005
Last Updated:	February 13, 2007
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016