NCT00690092

A Multi-center Study of Spherule-Derived Coccidioidin

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 of Pulmonary Histoplasmosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Nielsen BioSciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coccidioidomycosis

Interventions

Type	Name	Description
BIOLOGICAL	Spherule-derived coccidioidin	1.27 ug of sterile, injectable product (spherule-derived coccidioidin). Product was administered once by intradermal injection along with positive and negative control agents and results read after 48 hours.

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2008-06-04
• Last updated: 2013-10-29

Locations

4 sites across 1 country: United States