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| Name | Class |
|---|---|
| Sr Consultants Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology. |
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| 2 | Active Comparator | Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive). |
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| 3 | Active Comparator | Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spherule-derived coccidioidin | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
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Inclusion Criteria:
Good Health (absence of active medical disease)
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
Lifetime residence in the states of WA, OR, ID, or MT
Never employed as an agricultural worker
Serology negative for C.immitis antibodies
Exclusion Criteria (All Groups):
Coccidioidomycosis Group:
Histoplasmosis Group:
Naive Control Group:
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| Name | Affiliation | Role |
|---|---|---|
| Harry S Nielsen, Ph.D. | Nielsen BioSciences, Inc. | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Center AVAHCS, Univ. of Arizona | Tucson | Arizona | 85723 | United States | ||
| Kern Facility Medical Group |
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| ID | Term |
|---|---|
| D003047 | Coccidioidomycosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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|
| Bakersfield |
| California |
| 93306 |
| United States |
| Blair Clinic | Blair | Nebraska | 68001 | United States |
| Spokane Allergy and Asthma Center | Spokane | Washington | 99204 | United States |