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A Multi-center Study of Spherule-Derived Coccidioidin

Primary Purpose

Coccidioidomycosis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Spherule-derived coccidioidin

About this trial

This is an interventional diagnostic trial for Coccidioidomycosis focused on measuring Coccidioidin, Coccidioidin SD, Spherule-derived coccidioidin, Coccidioidomycosis, Valley Fever, Coccidioides immitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Health Sciences Center AVAHCS, Univ. of Arizona
Kern Facility Medical Group
Blair Clinic
Spokane Allergy and Asthma Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00690092

First Posted

June 2, 2008

Last Updated

October 28, 2013

Sponsor

Nielsen BioSciences, Inc.

Collaborators

Sr Consultants Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00690092

Brief Title

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

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nielsen BioSciences, Inc.

Collaborators

Sr Consultants Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coccidioidomycosis

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Spherule-derived coccidioidin

Other Intervention Name(s)

Coccidioidin SD (proposed trade name)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

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.

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: