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

NCT00486382 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-04-03

No results posted yet for this study

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.

Conditions

  • Visceral Leishmaniasis
  • Post-kala-azar Dermal Leishmaniasis

Interventions

BIOLOGICAL

Leish-111f + MPL-SE Adjuvant

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Shyam Sundar, MD · Banaras Hindu University

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • India

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 NCT00486382 on ClinicalTrials.gov