Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
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Purpose
The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given as three injections every 28 days at each of three dose levels of Leish-111f protein, in combination with standard pentavalent antimony therapy in adult patients with mucosal leishmaniasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Leishmaniasis, Mucocutaneous |
Biological: Leish-111f + MPL-SE vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate Safety, Tolerability, and Immunogenicity of Leish-111f + MPL-SE Vaccine in Combination With Pentavalent Antimony in Treatment of Mucosal 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 mucosal leishmaniasis
| Estimated Enrollment: | 48 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | May 2006 |
Mucosal leishmaniasis is a disfiguring and possibly fatal infection. All available medical therapies require weeks of treatment and cause significant toxicity. In Peru, the standard therapy is daily intravenous (IV) pentavalent antimony (20 mg/kg/day) for 28 days. It appears that Leishmania infections can be eliminated by T helper 1 immune responses. These findings argue that a vaccine that augments mucosal leishmaniasis patients’ T helper 1 responses 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 standard chemotherapy with pentavalent antimony (20 mg/kg/day for 28 days) in patients with mucosal leishmaniasis.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with mucosal leishmaniasis confirmed by a positive smear, in vitro culture or PCR test
Exclusion Criteria:
- Mucosal leishmaniasis must not involve the vocal cords or cause respiratory distress, and there must be no evidence of other disease.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00111514
| Peru | |
| Clínica de Leishmaniasis, Hospital Nacional Sur Este EsSalud | |
| Cusco, Peru | |
| Universidad Peruana Cayetano Heredia | |
| Lima, Peru, 100 | |
| Principal Investigator: | Alejandro Llanos-Cuentas, MD | Universidad Peruana Cayetano Heredia | |
| Study Director: | Franco M Piazza, MD, MPh | IDRI |
More Information
No publications provided by IDRI
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00111514 History of Changes |
| Other Study ID Numbers: | IDRI-LMVTC-102 |
| Study First Received: | May 20, 2005 |
| Last Updated: | February 13, 2007 |
| Health Authority: | Peru: General Directorate of Pharmaceuticals, Devices, and Drugs United States: Food and Drug Administration |
Keywords provided by IDRI:
|
Leishmaniasis Subunit vaccine therapeutic T-cell pentavalent antimony |
Additional relevant MeSH terms:
|
Leishmaniasis Leishmaniasis, Mucocutaneous Euglenozoa Infections Leishmaniasis, Cutaneous Parasitic Diseases |
Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic |
ClinicalTrials.gov processed this record on March 03, 2015