NCT00690092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2005

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

June 2, 2008

Last Update Submit

October 28, 2013

Conditions

Coccidioidomycosis

Keywords

CoccidioidinCoccidioidin SDSpherule-derived coccidioidinCoccidioidomycosisValley FeverCoccidioides immitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (3)

1

ACTIVE COMPARATOR

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

Biological: Spherule-derived coccidioidin

2

ACTIVE COMPARATOR

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

Biological: Spherule-derived coccidioidin

3

ACTIVE COMPARATOR

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

Biological: Spherule-derived coccidioidin

Interventions

Spherule-derived coccidioidinBIOLOGICAL

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.

Also known as: Coccidioidin SD (proposed trade name)
123

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Health Sciences Center AVAHCS, Univ. of Arizona

Tucson, Arizona, 85723, United States

Location

Kern Facility Medical Group

Bakersfield, California, 93306, United States

Location

Blair Clinic

Blair, Nebraska, 68001, United States

Location

Spokane Allergy and Asthma Center

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Coccidioidomycosis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Harry S Nielsen, Ph.D.

    Nielsen BioSciences, Inc.

    STUDY DIRECTOR

  • Royce Johnson, M.D.

    Kern Medical Center

    PRINCIPAL INVESTIGATOR

  • Neil Ampel, M.D.

    University of Arizona, Tucson

    PRINCIPAL INVESTIGATOR

  • Brad Sawtelle, M.D.

    Blair, NE

    PRINCIPAL INVESTIGATOR

  • Stephen Kernerman, D.O.

    Spokane, WA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 4, 2008

Study Start

May 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

US(4)