Clinical Trial: A Multi-center Study of Spherule-Derived Coccidioidin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety, Sensitivity and Specificity of Spherule-derived Coccidioidin in Naive Adults, in Adults With a History of Pulmonary Coccidioidomycosis and in Adults With a History

Brief Summary: Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test antigen was evaluated in three different populations of adult volunteers to determine the safety and efficacy of the product in the assessment of delayed-type hypersensitivity to Coccidioides immitis. Induration greater than or equal to 5 mm after 48 hours was considered positive for exposure to C. immitis.

Detailed Summary:
Sponsor: Nielsen BioSciences, Inc.

Current Primary Outcome: To determine the ability of spherule-derived coccidioidin to detect cellular hypersensitivity to C. immitis by a positive DTH skin test in a population with a history of pulmonary coccidioidomycosis. [ Time Frame: 48 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Determine the specificity of spherule-derived coccidioidin by testing the skin test antigen in naive adult volunteer and volunteers with a history of pulmonary histoplasmosis. [ Time Frame: 48 hours ]

Original Secondary Outcome: Same as current

Information By: Nielsen BioSciences, Inc.

Dates:
Date Received: June 2, 2008
Date Started: May 2005
Date Completion:
Last Updated: October 28, 2013
Last Verified: October 2013