Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00111514 |
Recruitment Status :
Completed
First Posted : May 23, 2005
Last Update Posted : February 15, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leishmaniasis, Mucocutaneous | Biological: Leish-111f + MPL-SE vaccine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | July 2004 |
Study Completion Date : | May 2006 |

- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
ClinicalTrials.gov Identifier: | NCT00111514 |
Other Study ID Numbers: |
IDRI-LMVTC-102 |
First Posted: | May 23, 2005 Key Record Dates |
Last Update Posted: | February 15, 2007 |
Last Verified: | February 2007 |
Leishmaniasis Subunit vaccine therapeutic T-cell pentavalent antimony |
Leishmaniasis Leishmaniasis, Mucocutaneous Euglenozoa Infections Protozoan Infections Parasitic Diseases |
Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Leishmaniasis, Cutaneous |