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

• Occurrence of dose limiting toxicity
• Adverse events

• 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

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.

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