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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 16, 2014