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

Tracking Information
First Submitted Date ICMJE	May 20, 2005
First Posted Date ICMJE	May 23, 2005
Last Update Posted Date	February 15, 2007
Study Start Date ICMJE	July 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: June 23, 2005)	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; (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 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; (submitted: June 23, 2005)	48
Original Enrollment ICMJE	Same as current
Study 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	No
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