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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: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine (Recombinant Three-antigen Leishmania Polyprotein LEISH-F2 With Adjuvant MPL-SE in Combination With Sodium Stibogluconate in the Treatment of Patients With Post Kala-Azar Dermal Leishmaniasis |
| Estimated Enrollment: | 42 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | July 2010 (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| Contact: Eltahir A.G. Khalil, MBBS, MRCS | +24911793267 | eltahirk@iend.org |
| Sudan | |
| IEND | Recruiting |
| Khartoum, Sudan | |
| Principal Investigator: | Eltahir AG Khalil, MBBS | IEND |
| Study Director: | Franco Piazza, MD, MPH | IDRI |
More Information
| Responsible Party: | Institute of Endemic Diseases and Infectious Disease Research Institute ( Professor Eltahir Khalil/PI and Franco Piazza/IDRI Study Director ) |
| Study ID Numbers: | IDRI-LVPTC-107, BMGF #39129 |
| Study First Received: | September 21, 2009 |
| Last Updated: | September 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00982774 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
PKDL |
|
Leishmaniasis Anti-Infective Agents Protozoan Infections Antiprotozoal Agents Skin Diseases, Parasitic Skin Diseases Antiplatyhelmintic Agents Mastigophora Infections Anthelmintics |
Schistosomicides Pharmacologic Actions Antiparasitic Agents Skin Diseases, Infectious Antimony Sodium Gluconate Therapeutic Uses Leishmaniasis, Visceral Sarcomastigophora Infections Parasitic Diseases |