A Multi-center Study of Spherule-Derived Coccidioidin

This study has been completed.
Sponsor:
Collaborator:
SR Consultants, Inc.
Information provided by:
Nielsen BioSciences, Inc.
ClinicalTrials.gov Identifier:
NCT00690092
First received: June 2, 2008
Last updated: October 28, 2013
Last verified: October 2013

June 2, 2008
October 28, 2013
May 2005
September 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00690092 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Multi-center Study of Spherule-Derived Coccidioidin
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Coccidioidomycosis
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: 1
    Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.
    Intervention: Biological: Spherule-derived coccidioidin
  • Active Comparator: 2
    Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive).
    Intervention: Biological: Spherule-derived coccidioidin
  • Active Comparator: 3
    Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology.
    Intervention: Biological: Spherule-derived coccidioidin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
September 2007
September 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00690092
S104-1, S104-2, S104-3
No
Harry S. Nielsen, Ph.D., Allermed Laboratories, Inc.
Nielsen BioSciences, Inc.
SR Consultants, Inc.
Study Director: Harry S Nielsen, Ph.D. Nielsen BioSciences, 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
Nielsen BioSciences, Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP