Clinical trial NCT00690092: A Multi-center Study of Spherule-Derived Coccidioidin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coccidioidomycosis
Keywords: Coccidioidin
Coccidioidin SD
Spherule-derived coccidioidin
Coccidioidomycosis
Valley Fever
Coccidioides immitis
Lead sponsor: Nielsen BioSciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sr Consultants Inc.
First posted: 2008-06-04
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
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.
timeFrame: 48 hours
Secondary outcomes:
measure: 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.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Health Sciences Center AVAHCS, Univ. of Arizona
state: Arizona
city: Bakersfield
country: United States
facility: Kern Facility Medical Group
state: California
city: Blair
country: United States
facility: Blair Clinic
state: Nebraska
city: Spokane
country: United States
facility: Spokane Allergy and Asthma Center
state: Washington
Study officials:
affiliation: Nielsen BioSciences, Inc.
name: Harry S Nielsen, Ph.D.
role: STUDY_DIRECTOR
affiliation: Kern Medical Center
name: Royce Johnson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona, Tucson
name: Neil Ampel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Blair, NE
name: Brad Sawtelle, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Spokane, WA
name: Stephen Kernerman, D.O.
role: PRINCIPAL_INVESTIGATOR
References: