Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
113 participants
INTERVENTIONAL
2005-05-31
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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1
Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.
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
Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive).
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
Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Sr Consultants Inc.
INDUSTRY
Nielsen BioSciences, Inc.
INDUSTRY
Responsible Party
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Allermed Laboratories, Inc.
Principal Investigators
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Harry S Nielsen, Ph.D.
Role: STUDY_DIRECTOR
Nielsen BioSciences, Inc.
Royce Johnson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kern Medical Center
Neil Ampel, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Arizona, Tucson
Brad Sawtelle, M.D.
Role: PRINCIPAL_INVESTIGATOR
Blair, NE
Stephen Kernerman, D.O.
Role: PRINCIPAL_INVESTIGATOR
Spokane, WA
Locations
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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
Countries
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Other Identifiers
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S104-1, S104-2, S104-3
Identifier Type: -
Identifier Source: org_study_id