A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for 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: NCT01011309
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : November 18, 2013
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):

November 9, 2009
November 11, 2009
September 16, 2013
November 18, 2013
December 11, 2013
October 2009
May 2011   (Final data collection date for primary outcome measure)
  • Date of Clinical Cure [ Time Frame: Day 84 ]
    Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.
  • Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. [ Time Frame: Day 0 through Day 84 ]
    Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.
  • To Compare the Efficacy of Immunotherapy With the LEISH-F2 + MPL-SE Vaccine to the Efficacy of Chemotherapy With Sodium Stibogluconate in the Treatment of CL [ Time Frame: Day 84 ]
  • To Compare the Safety of Immunotherapy With the Vaccine to the Safety of Chemotherapy With Sodium Stibogluconate. [ Time Frame: Day 84 ]
Complete list of historical versions of study NCT01011309 on Archive Site
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) [ Time Frame: Days 0, 56 or 84, and 168 ]
Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0.
To Assess the Immunogenicity of the Vaccine by Evaluating IgG Antibody and T-cell Responses to the LEISH-F2 Protein and Soluble Leishmania Antigen (SLA). [ Time Frame: Day 84 ]
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A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in the Treatment of Patients With Cutaneous Leishmaniasis
The purpose of this study is to determine the efficacy, safety, and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis, including cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.
A phase 2, randomized, open-label, controlled study to evaluate the efficacy, safety, and immunogenicity of the vaccine administered three times (10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56) in the treatment of adults and adolescents with CL compared to treatment with standard chemotherapy (20 mg/kg/day sodium stibogluconate for 20 days). The proportion cured in each group will be determined using clinical criteria.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cutaneous Leishmaniasis
  • Biological: LEISH-F2 + MPL-SE
    10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56
    Other Name: There are no other names for the vaccine.
  • Drug: Sodium stibogluconate
    20 mg/kg/day IV daily for 20 days
    Other Name: Marfan SSG
  • Experimental: LEISH-F2 + MPL-SE vaccine
    Recombinant three antigen Leishmania polyprotein + MPL-SE adjuvant
    Intervention: Biological: LEISH-F2 + MPL-SE
  • Active Comparator: Sodium stibogluconate (SSG)
    20 mg/kg/day IV for 20 days
    Intervention: Drug: Sodium stibogluconate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females ≥ 12 years and < 70 years of age. In the first stage of the study, only patients aged ≥ 18 years and < 70 years will be enrolled. In the second stage, enrollment will also include adolescent patients aged ≥ 12 - < 18 years.
  • Must have a clinical diagnosis of cutaneous leishmaniasis confirmed by positive identification of Leishmania parasite and identification of L. peruviana by PCR.
  • Lesions must be clear of any superinfection prior to enrollment.
  • Female patients of childbearing age must have a negative serum pregnancy test at screening, a negative urine pregnancy test within 24 hours before the first vaccination or initiation of chemotherapy, must not be breast-feeding, and are required to use adequate contraception through Day 84 of the study. These precautions are necessary due to unknown effects that LEISH-F2 + MPL SE, sodium stibogluconate might have in a fetus or newborn infant.
  • The following laboratory blood tests must have values within the normal ranges at screening: sodium, potassium, urea, total bilirubin, ALT, AST, glucose, creatinine, alkaline phosphatase, total WBC count and platelet count. Hemoglobin may exceed the ULN since patients reside in the Andes at very high altitude (up to 20 g/dL)
  • The following serology tests must be negative at screening: HIV-1/2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. All patients (or their parents) will receive HIV-related counseling prior to testing. Patients with positive HIV test results will be referred for counseling and treatment as appropriate.
  • Potential study patients (or their guardians) must give written informed consent, be willing to be housed in Lima for a minimum of 20 days and up to 63 days, able to attend all required follow-up visits, have a permanent address, and be reachable by study site personnel.

Exclusion Criteria:

  • Infection with species other than L.peruviana as confirmed by PCR.
  • Presence of eleven or more active cutaneous leishmaniasis lesions.
  • The diameter of the ulcerated area of any single lesion is >60 mm.
  • Presence of lesions with superinfection at time of enrollment.
  • History of mucocutaneous leishmaniasis or diagnosis of mucocutaneous leishmaniasis at screening.
  • History of previous exposure to Leishmania vaccines.
  • Known use of injected or oral corticosteroids within 6 weeks prior to the first vaccination or initiation of chemotherapy.
  • Participation in another experimental protocol or receipt of any investigational products within 30 days prior to the first vaccination or initiation of chemotherapy.
  • History of autoimmune disease or other causes of immunosuppressive states.
  • History or evidence of any acute or chronic illness that, in the opinion of the study clinician, may interfere with the evaluation of the safety or the immunogenicity of the vaccine. (Patients presenting with concomitant illness will be referred for standard clinical care).
  • History of use of any medication that, in the opinion of the study clinician, may interfere with the evaluation of the safety or the immunogenicity of the vaccine.
  • History of significant psychiatric illness.
  • Drug addiction including alcohol abuse.
  • Patients with a history of previous anaphylaxis, severe allergic reaction to vaccines or unknown allergens, or allergic reaction to eggs.
  • Patients who are unlikely to cooperate with the requirements of the study protocol.
  • ECG with evidence of ventricular arrythmias ≥ 4 extra systoles per minute.
  • Known allergy or contraindication to chemotherapy (e.g., known reaction to pentavalent antimonials, cardiopathy, myocarditis).
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Franco Piazza, MD, MPH IDRI
November 2013

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