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Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen

NCT00633009 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-11-20

Study results available
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Summary

The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of LtSTA. The measurements of non-specific reactivity due to components of the antigen solution and the product's ability to sensitize lymphocytes of Leishmania naïve persons when administered intradermally. The presence or absence of a local inflammatory response to the first skin test with each of three doses of LtSTA will provide insight on the specificity of the antigen in a naïve population. The local inflammatory response to LtSTA following the first and second repeat skin tests will indicate if the antigen is sensitizing after intradermal administration.

Conditions

  • Cutaneous Leishmaniasis

Interventions

BIOLOGICAL

Leishmania tropica Skin Test Antigen (LtSTA)

Administer 15 ug, 30 ug or 50 ug of LtSTA into DTH positive volunteers. Repeat drug administration 30 days after initial injection and 60 days after initial injection. Read and interpret reaction 48 hours after each injection. Observe subjects for conversion or adverse reaction.

BIOLOGICAL

Leishmania tropica Skin Test Antigen Placebo (Placebo)

Administer Placebo concurrently with 15 ug, 30 ug and 50 ug doses of LtSTA. Read and interpret the reaction 48 hours after injection. Observe subjects for reaction to Placebo

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Nielsen BioSciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Harry S Nielsen, Ph.D. · Nielsen BioSciences, Inc.

  • Donald M Brandon, M.D. · California Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-09-30
Completion
2010-01-31

Countries

  • United States

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 NCT00633009 on ClinicalTrials.gov