Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis
- Conditions
- Leishmaniasis, Cutaneous
- Registration Number
- NCT00111553
- Lead Sponsor
- Access to Advanced Health Institute (AAHI)
- Brief Summary
This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with cutaneous leishmaniasis.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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
- Nine or more active cutaneous lesions
- Lesion diameter >60mm
- Previous exposure to Leishmania vaccines or to MPL-SE
- Pregnant or breastfeeding female
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Occurrence of dose limiting toxicity Adverse events
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Universidade Federal de Minas Gerais
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária
🇧🇷Januária, Minas Gerais, Brazil
Universidade Federal de Minas Gerais🇧🇷Belo Horizonte, Minas Gerais, Brazil