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

This study has been completed.

Sponsor:

Collaborator:

Bill and Melinda Gates Foundation

Information provided by:

IDRI

ClinicalTrials.gov Identifier:

NCT00111514

First received: May 20, 2005

Last updated: February 13, 2007

Last verified: February 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

May 20, 2005

Last Updated Date

February 13, 2007

Start Date ^ICMJE

July 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Occurrence of dose-limiting toxicity
Adverse events

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00111514 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Leishmaniasis, Mucocutaneous

Intervention ^ICMJE

Biological: Leish-111f + MPL-SE vaccine

Study Arms

Not Provided

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Estimated Completion Date

May 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 60 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Peru

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00111514

Other Study ID Numbers ^ICMJE

IDRI-LMVTC-102

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

IDRI

Collaborators ^ICMJE

Bill and Melinda Gates Foundation

Investigators ^ICMJE

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

PRS Account

IDRI

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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