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A Multi-Center Study of Spherule-Derived Coccidioidin

This study has been completed.
Sponsor:
Collaborator:
SR Consultants, Inc.
Information provided by:
Allermed Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00690092
First received: June 2, 2008
Last updated: June 3, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Coccidioidomycosis
 Biological: Spherule-derived coccidioidin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allermed Laboratories, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: May 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.
 Biological: 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 Name: Coccidioidin SD (proposed trade name)
Active Comparator: 2
Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive).
 Biological: 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 Name: Coccidioidin SD (proposed trade name)
Active Comparator: 3
Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology.
 Biological: 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 Name: Coccidioidin SD (proposed trade name)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690092

Locations
United States, Arizona
Health Sciences Center AVAHCS, Univ. of Arizona
Tucson, Arizona, United States, 85723
United States, California
Kern Facility Medical Group
Bakersfield, California, United States, 93306
United States, Nebraska
Blair Clinic
Blair, Nebraska, United States, 68001
United States, Washington
Spokane Allergy and Asthma Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Allermed Laboratories, Inc.
SR Consultants, Inc.
Investigators
Study Director: Harry S Nielsen, Ph.D. Allermed Laboratories, Inc.
Principal Investigator: Royce Johnson, M.D. Kern Medical Center
Principal Investigator: Neil Ampel, M.D. University of Arizona, Tucson
Principal Investigator: Brad Sawtelle, M.D. Blair, NE
Principal Investigator: Stephen Kernerman, D.O. Spokane, WA
  More Information

No publications provided

Responsible Party: Harry S. Nielsen, Ph.D., Allermed Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00690092     History of Changes
Other Study ID Numbers: S104-1, S104-2, S104-3
Study First Received: June 2, 2008
Last Updated: June 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Allermed Laboratories, Inc.:
Coccidioidin
Coccidioidin SD
Spherule-derived coccidioidin
 Coccidioidomycosis
Valley Fever
Coccidioides immitis

Additional relevant MeSH terms:
Coccidioidomycosis
Coccidiosis
Mycoses
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on June 18, 2013