A Multi-center Study of Spherule-Derived Coccidioidin

Nielsen BioSciences

Status and phase: Completed; Phase 3

Conditions: Coccidioidomycosis

Treatments: Biological: Spherule-derived coccidioidin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00690092

S104-1, S104-2, S104-3

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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113 participants in 3 patient groups

1

Active Comparator group

Description:

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

Treatment:

Biological: Spherule-derived coccidioidin

2

Active Comparator group

Description:

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

Treatment:

Biological: Spherule-derived coccidioidin

3

Active Comparator group

Description:

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

Treatment:

Biological: Spherule-derived coccidioidin