NCT00982774

Safety and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine With SSG for Patients With PKDL

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Access to Advanced Health Institute (AAHI) · Academic / Other
• Sex: All
• Age: 7 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Post Kala Azar Dermal Leishmaniasis

Interventions

Type	Name	Description
BIOLOGICAL	LEISH-F2 + MPL-SE vaccine	LEISH-F2 protein (10 ug) + MPL-SE (25ug) Three injections, 14 days apart

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-09-23
• Last updated: 2011-06-27

Locations

1 site across 1 country: Sudan