A Multi-center Study of Spherule-Derived Coccidioidin

Phase 3

Completed

• Conditions: Coccidioidomycosis
• Interventions: Biological: Spherule-derived coccidioidin

• Registration Number: NCT00690092
• Lead Sponsor: Nielsen BioSciences, Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Spherule-derived coccidioidin	Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.
2	Spherule-derived coccidioidin	Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive).
3	Spherule-derived coccidioidin	Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Kern Facility Medical Group; 🇺🇸 Bakersfield, California, United States

Spokane Allergy and Asthma Center; 🇺🇸 Spokane, Washington, United States

Health Sciences Center AVAHCS, Univ. of Arizona; 🇺🇸 Tucson, Arizona, United States

Blair Clinic; 🇺🇸 Blair, Nebraska, United States