A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Intervention: LEISH-F2 + MPL-SE; Sodium stibogluconate
Intervention description: 10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56; 20 mg/kg/day IV daily for 20 days
Intervention MeSH terms: Antimony Sodium Gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Leishmaniasis; vaccine; immunotherapy

Summary:

      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.
    

Eligibility criteria:

        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).