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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00690092

Enrollment

113

Registered

2008-06-04

Start date

2005-05-31

Completion date

2007-09-30

Last updated

2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coccidioidomycosis

Keywords

Coccidioidin, Coccidioidin SD, Spherule-derived coccidioidin, Coccidioidomycosis, Valley Fever, Coccidioides immitis

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.

Interventions

BIOLOGICALSpherule-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026