A Multi-center Study of Spherule-Derived Coccidioidin
Completed · Phase 3
Conditions studied: Coccidioidomycosis
In brief
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.
Key facts
- Study ID
- NCT00690092
- Run by
- Nielsen BioSciences, Inc.
- People needed
- 113
- Starts
- 2005-05-01
- Expected to finish
- 2007-09-01
- Last updated by the study team
- 2013-10-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
Where it is running
- Health Sciences Center AVAHCS, Univ. of Arizona — Tucson, Arizona, United States
- Kern Facility Medical Group — Bakersfield, California, United States
- Blair Clinic — Blair, Nebraska, United States
- Spokane Allergy and Asthma Center — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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