Status:
COMPLETED
A Multi-center Study of Spherule-Derived Coccidioidin
Lead Sponsor:
Nielsen BioSciences, Inc.
Collaborating Sponsors:
Sr Consultants Inc.
Conditions:
Coccidioidomycosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 efficac...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00690092
Start Date
May 1 2005
End Date
September 1 2007
Last Update
October 29 2013
Active Locations (4)
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1
Health Sciences Center AVAHCS, Univ. of Arizona
Tucson, Arizona, United States, 85723
2
Kern Facility Medical Group
Bakersfield, California, United States, 93306
3
Blair Clinic
Blair, Nebraska, United States, 68001
4
Spokane Allergy and Asthma Center
Spokane, Washington, United States, 99204