NCT00633009View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

September 30, 2009

Study Completion Date

January 31, 2010

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

Trial Locations (1)

92103-6204

California Research Foundation, San Diego

Sponsors
All Listed Sponsors
collaborator

U.S. Army Medical Research and Development Command

FED

lead

Nielsen BioSciences, Inc.

INDUSTRY

NCT00633009 - Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen | Biotech Hunter | Biotech Hunter