NCT00111553

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (planned)
• Sponsor: Access to Advanced Health Institute (AAHI) · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leishmaniasis, Cutaneous

Interventions

Type	Name	Description
BIOLOGICAL	Leish-111f + MPL-SE vaccine

Timeline

• Start date: 2004-10-01
• Completion: 2006-08-01
• First posted: 2005-05-24
• Last updated: 2007-02-15

Locations

2 sites across 1 country: Brazil