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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111553
Recruitment Status : Completed
First Posted : May 24, 2005
Last Update Posted : February 15, 2007
Bill and Melinda Gates Foundation
Information provided by:

May 23, 2005
May 24, 2005
February 15, 2007
October 2004
Not Provided
  • Occurrence of dose limiting toxicity
  • Adverse events
Same as current
Complete list of historical versions of study NCT00111553 on Archive Site
  • 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
Same as current
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Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis
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.

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.

Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Leishmaniasis, Cutaneous
Biological: Leish-111f + MPL-SE vaccine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Bill and Melinda Gates Foundation
Principal Investigator: Evaldo Nascimento, MD Federal University of Minas Gerais
Study Director: Franco M Piazza, MD, MPH Infectious Disease Research Institute (IDRI)
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP