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Sponsors and Collaborators: |
Allermed Laboratories, Inc. SR Consultants, Inc. |
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Information provided by: | Allermed Laboratories, Inc. |
ClinicalTrials.gov Identifier: | NCT00690092 |
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.
Condition | Intervention | Phase |
---|---|---|
Coccidioidomycosis |
Biological: Spherule-derived coccidioidin |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
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 of Pulmonary Histoplasmosis |
Enrollment: | 113 |
Study Start Date: | May 2005 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.
|
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.
|
2: Active Comparator
Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive).
|
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.
|
3: Active Comparator
Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology.
|
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.
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Meets criteria specific to population groups:
History of coccidioidomycosis of at least 45 days duration confirmed by roentgenograph serologic or mycologic findings
History of pulmonary histoplasmosis
Exclusion Criteria (All Groups):
Coccidioidomycosis Group:
Histoplasmosis Group:
Naive Control Group:
United States, Arizona | |
Health Sciences Center AVAHCS, Univ. of Arizona | |
Tucson, Arizona, United States, 85723 | |
United States, California | |
Kern Facility Medical Group | |
Bakersfield, California, United States, 93306 | |
United States, Nebraska | |
Blair Clinic | |
Blair, Nebraska, United States, 68001 | |
United States, Washington | |
Spokane Allergy and Asthma Center | |
Spokane, Washington, United States, 99204 |
Study Director: | Harry S Nielsen, Ph.D. | Allermed Laboratories, Inc. |
Principal Investigator: | Royce Johnson, M.D. | Kern Medical Center |
Principal Investigator: | Neil Ampel, M.D. | University of Arizona, Tucson |
Principal Investigator: | Brad Sawtelle, M.D. | Blair, NE |
Principal Investigator: | Stephen Kernerman, D.O. | Spokane, WA |
Responsible Party: | Allermed Laboratories, Inc. ( Harry S. Nielsen, Ph.D. ) |
Study ID Numbers: | S104-1, S104-2, S104-3 |
Study First Received: | June 2, 2008 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00690092 |
Health Authority: | United States: Food and Drug Administration |
Coccidioidin Coccidioidin SD Spherule-derived coccidioidin |
Coccidioidomycosis Valley Fever Coccidioides immitis |
Fever Mycoses Coccidioidomycosis Histoplasmosis |