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

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by:
Infectious Disease Research Institute
ClinicalTrials.gov Identifier:
NCT00111553
First received: May 23, 2005
Last updated: February 13, 2007
Last verified: February 2007
  Purpose

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


Condition Intervention Phase
Leishmaniasis, Cutaneous
Biological: Leish-111f + MPL-SE vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Infectious Disease Research Institute:

Primary Outcome Measures:
  • Occurrence of dose limiting toxicity
  • Adverse events

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 45
Study Start Date: October 2004
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111553

Locations
Brazil
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária
Januária, Minas Gerais, Brazil, 39480-000
Sponsors and Collaborators
Infectious Disease Research Institute
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)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00111553     History of Changes
Other Study ID Numbers: IDRI-LCVTC-101
Study First Received: May 23, 2005
Last Updated: February 13, 2007
Health Authority: United States: Food and Drug Administration
Brazil: National Committee of Ethics in Research

Keywords provided by Infectious Disease Research Institute:
Leishmaniasis
Subunit vaccine
Therapeutic
T cell
Antimony

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine antimoniate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014