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

Post Kala Azar Dermal Leishmaniasis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Post Kala Azar Dermal Leishmaniasis

• NCT number: NCT00982774
• Study type: Interventional
• Source: IDRI
• Status: Completed
• Phase: Phase 1
• Start date: April 2009
• Completion date: April 2011