NCT00111553

Brief Summary

This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with cutaneous leishmaniasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

February 15, 2007

Status Verified

February 1, 2007

First QC Date

May 23, 2005

Last Update Submit

February 13, 2007

Conditions

Leishmaniasis, Cutaneous

Keywords

LeishmaniasisSubunit vaccineTherapeuticT cellAntimony

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 cutaneous leishmaniasis

Interventions

Leish-111f + MPL-SE vaccineBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Confirmed diagnosis of cutaneous leishmaniasis defined as positive identification of parasite from lesion biopsy
  • Normal lab values and electrocardiogram (ECG)
  • Negative for HIV, hepatitis B and C, and Chagas disease

You may not qualify if:

  • Nine or more active cutaneous lesions
  • Lesion diameter \>60mm
  • Previous exposure to Leishmania vaccines or to MPL-SE
  • Pregnant or breastfeeding female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária

Januária, Minas Gerais, 39480-000, Brazil

Location

MeSH Terms

Conditions

Leishmaniasis, CutaneousLeishmaniasis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Evaldo Nascimento, MD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

  • Franco M Piazza, MD, MPH

    Infectious Disease Research Institute (IDRI)

    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 23, 2005

First Posted

May 24, 2005

Study Start

October 1, 2004

Study Completion

August 1, 2006

Last Updated

February 15, 2007

Record last verified: 2007-02

Locations

BR(2)