A Multi-center Study of Spherule-Derived Coccidioidin

Coccidioidomycosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690092
• Other study ID #: S104-1, S104-2, S104-3
• Status: Completed
• Phase: Phase 3
• First received: June 2, 2008
• Last updated: October 28, 2013
• Start date: May 2005
• Est. completion date: September 2007

Study information

• Verified date: October 2013
• Source: Nielsen BioSciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Coccidioidomycosis

Intervention

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.

Locations

Country	Name	City	State
United States	Kern Facility Medical Group	Bakersfield	California
United States	Blair Clinic	Blair	Nebraska
United States	Spokane Allergy and Asthma Center	Spokane	Washington
United States	Health Sciences Center AVAHCS, Univ. of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Nielsen BioSciences, Inc.	Sr Consultants Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		48 hours	No
Secondary	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.		48 hours	No