- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00111514
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
February 13, 2007 updated by: IDRI
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cusco, Peru
- Clínica de Leishmaniasis, Hospital Nacional Sur Este EsSalud
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Lima, Peru, 100
- Universidad Peruana Cayetano Heredia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Adverse events
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Occurrence of dose-limiting toxicity
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Secondary Outcome Measures
Outcome Measure |
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IgG and T-cell response to Leish-111f vaccine
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Leish-111f skin test reactivity
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Safety of the vaccine with respect to the clinical course of mucosal leishmaniasis
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alejandro Llanos-Cuentas, MD, Universidad Peruana Cayetano Heredia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Study Completion
May 1, 2006
Study Registration Dates
First Submitted
May 20, 2005
First Submitted That Met QC Criteria
May 20, 2005
First Posted (ESTIMATE)
May 23, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
February 15, 2007
Last Update Submitted That Met QC Criteria
February 13, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDRI-LMVTC-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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