A Multi-center Study of Spherule-Derived Coccidioidin

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coccidioidomycosis

Intervention / Treatment
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* Biological: Spherule-derived coccidioidin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good Health (absence of active medical disease) Meets criteria specific to population groups: Coccidioidomycosis Group: History of coccidioidomycosis of at least 45 days duration confirmed by roentgenograph serologic or mycologic findings Histoplasmosis Group: History of pulmonary histoplasmosis Naive Control Group: 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): Active medical disease Alcohol abuse or illicit drug use Influenza-like illness within the past 4 weeks Immunizations within the past 4 weeks Current atopic or contact dermatitis, psoriasis, erythema nodosum, urticaria Current treatment with corticosteroids, cytotoxic or immunosuppressive drugs Immunodeficiency disease HIV infection Previous skin test with coccidioidin or SD Coccidioidin Pregnant or lactating Adverse reaction to thimerosal Adverse reaction to Candida or Trichophyton skin test antigens Coccidioidomycosis Group: Current cavitary or disseminated coccidioidomycosis History of histoplasmosis, or blastomycosis Histoplasmosis Group: History of coccidioidomycosis or blastomycosis Naive Control Group: History of coccidioidomycosis, histoplasmosis, blastomycosis Travel for more than 30 days in designated areas of CA, AZ, NV, UT, NM, TX and Mexico, Central and South America. Travel for more than 7 days in restricted areas of CA, AZ and TX.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology. | Biological: Spherule-derived coccidioidin<br>* 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.<br>* Other names: Coccidioidin SD (proposed trade name);|
| Active Comparator: 2<br>Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive). | Biological: Spherule-derived coccidioidin<br>* 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.<br>* Other names: Coccidioidin SD (proposed trade name);|
| Active Comparator: 3<br>Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology. | Biological: Spherule-derived coccidioidin<br>* 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.<br>* Other names: Coccidioidin SD (proposed trade name);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coccidioidin, Coccidioidin SD, Spherule-derived coccidioidin, Coccidioidomycosis, Valley Fever, Coccidioides immitis