NCT00121849

Brief Summary

This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with a previous exposure to the Leishmania parasite (but without current or past history of leishmaniasis).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

May 5, 2006

Status Verified

May 1, 2006

First QC Date

July 15, 2005

Last Update Submit

May 4, 2006

Conditions

Cutaneous Leishmaniasis

Keywords

Leishmaniasis,Subunit Vaccine,Prevention,T cell

Outcome Measures

Primary Outcomes (2)

  • Adverse events

  • Dose-limiting toxicities: hematology and serum chemistries at Screening and Days 7, 35, 63, and 84

Secondary Outcomes (2)

  • IgG and T-cell responses to the Leish-111f protein: immunological evaluations at Days 0, 84, and 168

  • Skin test reactivity to the Leish-111f protein at Days 0, 84, and 168

Interventions

Leish-111f + MPL-SE vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must have positive Montenegro skin test (reaction \>5 mm)
  • Must be in good general health with normal lab values
  • Negative for HIV, hepatitis B and C

You may not qualify if:

  • History of leishmaniasis or exposure to Leishmania vaccine or MPL-SE.
  • Pregnant or nursing female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Programa de Estudio y Control de Enfermedades Tropicales (PECET)

Medellín, Colombia

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

  • Iván D Vélez Bernal, MD, PhD

    PECET, Medellin, Colombia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2005

First Posted

July 21, 2005

Study Start

August 1, 2005

Study Completion

February 1, 2006

Last Updated

May 5, 2006

Record last verified: 2006-05

Locations

CO(1)