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 Locations| 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 | Infectious Disease Research Institute |
More Information
No publications provided by Infectious Disease Research Institute
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 Infectious Disease Research Institute:
|
Leishmaniasis Subunit vaccine therapeutic T-cell pentavalent antimony |
Additional relevant MeSH terms:
|
Leishmaniasis Leishmaniasis, Mucocutaneous Euglenozoa Infections Protozoan Infections Parasitic Diseases |
Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Leishmaniasis, Cutaneous |
ClinicalTrials.gov processed this record on May 19, 2013