Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Terminated NCT02839603 - Asymptomatic Leishmania Infection in HIV Patients
Completed NCT00370825 - Combination Chemotherapy for the Treatment of Indian Kala-Azar Phase 2
Recruiting NCT05426577 - Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure
Completed NCT01069198 - A Community Trial for Visceral Leishmaniasis (VL) N/A
Completed NCT00604955 - Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis Phase 4
Completed NCT00371995 - Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar Phase 2
Completed NCT01032187 - Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children Phase 4
Completed NCT00342823 - Immunogenetics of Visceral Leishmaniasis N/A
Completed NCT04003532 - LAMP Assay for the Diagnosis of Visceral Leishmaniasis
Terminated NCT01980199 - Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan Phase 2
Completed NCT00255567 - Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis Phase 3
Not yet recruiting NCT06118749 - Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study
Recruiting NCT04342715 - A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
Completed NCT02431143 - Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa Phase 2
Completed NCT01122771 - Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh Phase 3
Completed NCT03636659 - Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition Phase 1
Not yet recruiting NCT01566552 - Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis Phase 4
Completed NCT00696969 - Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis Phase 3
Completed NCT00318721 - Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar N/A
Completed NCT00216346 - Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis Phase 3