Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis
This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with cutaneous leishmaniasis.
Biological: Leish-111f + MPL-SE vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- 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
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||August 2006|
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.
|Universidade Federal de Minas Gerais|
|Belo Horizonte, Minas Gerais, Brazil, 31270-901|
|Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária|
|Januária, Minas Gerais, Brazil, 39480-000|
|Principal Investigator:||Evaldo Nascimento, MD||Federal University of Minas Gerais|
|Study Director:||Franco M Piazza, MD, MPH||Infectious Disease Research Institute (IDRI)|