NCT00111514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 15, 2007

Status Verified

February 1, 2007

First QC Date

May 20, 2005

Last Update Submit

February 13, 2007

Conditions

Leishmaniasis, Mucocutaneous

Keywords

LeishmaniasisSubunit vaccinetherapeuticT-cellpentavalent antimony

Outcome Measures

Primary Outcomes (2)

  • Occurrence of dose-limiting toxicity

  • Adverse events

Secondary Outcomes (3)

  • 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

Interventions

Leish-111f + MPL-SE vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clínica de Leishmaniasis, Hospital Nacional Sur Este EsSalud

Cusco, Peru

Location

Universidad Peruana Cayetano Heredia

Lima, 100, Peru

Location

Related Publications (1)

  • Llanos-Cuentas A, Calderon 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.

    PMID: 20851080DERIVED

MeSH Terms

Conditions

Leishmaniasis, MucocutaneousLeishmaniasis

Condition Hierarchy (Ancestors)

Leishmaniasis, CutaneousEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alejandro Llanos-Cuentas, MD

    Universidad Peruana Cayetano Heredia

    PRINCIPAL INVESTIGATOR

  • Franco M Piazza, MD, MPh

    Access to Advanced Health Institute (AAHI)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2005

First Posted

May 23, 2005

Study Start

July 1, 2004

Study Completion

May 1, 2006

Last Updated

February 15, 2007

Record last verified: 2007-02

Locations

PE(2)