Trial | NCT00690092  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    113
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.
Study Started
May 31
2005
Primary Completion
Sep 30
2007
Study Completion
Sep 30
2007
Last Update
Oct 29
2013
Estimate

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 names: Coccidioidin SD (proposed trade name)

1 Active Comparator

Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.

2 Active Comparator

Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive).

3 Active Comparator

Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology.

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.
No Results Posted