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

• ClinicalTrials.gov Identifier: NCT00111514
• Recruitment Status: Completed
• First Posted: May 23, 2005
• Last Update Posted: February 15, 2007
• Sponsor: IDRI
• Collaborator: Bill and Melinda Gates Foundation
• Information provided by: IDRI

Tracking Information

• First Submitted Date: May 20, 2005
• First Posted Date: May 23, 2005
• Last Update Posted Date: February 15, 2007
• Study Start Date: July 2004
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: June 23, 2005)

• Occurrence of dose-limiting toxicity
• Adverse events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 23, 2005)

• 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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Leishmaniasis, Mucocutaneous
• Intervention: 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 48
• Original Enrollment: Same as current
• Study Completion Date: May 2006
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Peru

Administrative Information

• NCT Number: NCT00111514
• Other Study ID Numbers: 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: IDRI
• Collaborators: Bill and Melinda Gates Foundation

Investigators

• 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