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| Sponsor: | Infectious Disease Research Institute |
|---|---|
| Information provided by: | Infectious Disease Research Institute |
| ClinicalTrials.gov Identifier: | NCT00982774 |
Purpose
A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of three injections of 10 µg LEISH-F2 + 25 µg MPL-SE given at 14-day intervals as an adjunct to standard chemotherapy with sodium stibogluconate (20 mg/kg/day for 40 days) in patients with PKDL.
| Condition | Intervention | Phase |
|---|---|---|
|
Post Kala Azar Dermal Leishmaniasis |
Biological: LEISH-F2 + MPL-SE vaccine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in Combination With SSG in the Treatment of Patients With PKDL |
| Enrollment: | 42 |
| Study Start Date: | April 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 7 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Professor Eltahir Khalil/PI and Franco Piazza/IDRI Study Director, Institute of Endemic Diseases and Infectious Disease Research Institute |
| ClinicalTrials.gov Identifier: | NCT00982774 History of Changes |
| Other Study ID Numbers: | IDRI-LVPTC-107 |
| Study First Received: | September 21, 2009 |
| Last Updated: | June 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
PKDL |
|
Leishmaniasis Leishmaniasis, Visceral Euglenozoa Infections Protozoan Infections |
Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases |