NCT00633009

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

A Blinded, Placebo Controlled Study Evaluating Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen (LtSTA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Nielsen BioSciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-09-01
• Completion: 2010-01-01
• First posted: 2008-03-11
• Last updated: 2013-11-20
• Results posted: 2012-12-06

Locations

1 site across 1 country: United States