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

NCT00982774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2011-06-27

No results posted yet for this study

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

BIOLOGICAL

LEISH-F2 + MPL-SE vaccine

LEISH-F2 protein (10 ug) + MPL-SE (25ug) Three injections, 14 days apart

Sponsors & Collaborators

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Eltahir AG Khalil, MBBS · IEND

  • Franco Piazza, MD, MPH · Access to Advanced Health Institute (AAHI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Sudan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00982774 on ClinicalTrials.gov