Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India

Visceral Leishmaniasis Clinical Trial

Official title: A Phase 1, Open-Label, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-111F + MPL-SE Vaccine (Recombinant Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE) in Healthy Adults In India

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe and whether it can or cannot produce a protective response against visceral leishmaniasis when injected to healthy subjects.

Clinical Trial Description

The purpose of this study is to determine the safety, tolerability, and immunogenicity of an investigational vaccine being developed for immunotherapy of visceral leishmaniasis (VL) and post kala-azar dermal leishmaniasis (PKDL). The vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f) together with adjuvant MPL-SE.

The primary objective is to evaluate the safety and tolerability of the Leish-111f + MPL-SE vaccine given as three subcutaneous injections every 28 days at each of three dose levels of the Leish-111f protein (5 μg, 10 μg, or 20 μg) together with MPL-SE adjuvant (25 μg) in healthy adults.

The secondary objective is to assess the immunogenicity of the vaccine by evaluating T-cell and antibody response to the Leish-111f protein of the vaccine. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Post-kala-azar Dermal Leishmaniasis
• Visceral Leishmaniasis

• NCT number: NCT00486382
• Study type: Interventional
• Source: IDRI
• Status: Completed
• Phase: Phase 1
• Start date: April 2007
• Completion date: November 2008