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

February 13, 2007 updated by: IDRI

Randomized, Double-Blind, Adjuvant- and Placebo-Controlled, Dose-Escalating Study to Evaluate Safety, Tolerability, and Immunogenicity of Leish-111f + MPL-SE Vaccine With Meglumine Antimoniate (Glucantime) in Cutaneous Leishmaniasis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cutaneous leishmaniasis is a disfiguring infection that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of leishmania infection. All available medical therapies require weeks of treatment and cause significant toxicity. In Brazil, a standard therapy is Glucantime treatment, administered in cycles of 10 consecutive, once daily, intramuscular injections (Glucantime 10 mg/kg, maximum of 850 mg), followed by 11 consecutive days without Glucantime injections (rest days). At the completion of each cycle, a study physician examines the patient to determine if a further cycle of Glucantime treatment is indicated.

It appears that Leishmania infections can be eliminated by T helper 1 immune responses. This finding argues that a vaccine that augments cutaneous leishmaniasis patients' T helper 1 response 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 the standard chemotherapy with Glucantime cycles, as described above in patients with cutaneous leishmaniasis.

Study Type

Interventional

Enrollment

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 31270-901
        • Universidade Federal de Minas Gerais
      • Januária, Minas Gerais, Brazil, 39480-000
        • Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events
Occurrence of dose limiting toxicity

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IDRI

Collaborators

Bill and Melinda Gates Foundation

Investigators

  • Principal Investigator: Evaldo Nascimento, MD, Federal University of Minas Gerais
  • Study Director: Franco M Piazza, MD, MPH, Infectious Disease Research Institute (IDRI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

May 23, 2005

First Submitted That Met QC Criteria

May 23, 2005

First Posted (ESTIMATE)

May 24, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2007

Last Update Submitted That Met QC Criteria

February 13, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDRI-LCVTC-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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