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A Multi-center Study of Spherule-Derived Coccidioidin

NCT00690092 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2013-10-29

No results posted yet for this study

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.

Conditions

  • Coccidioidomycosis

Interventions

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.

Sponsors & Collaborators

  • Sr Consultants Inc.

    collaborator INDUSTRY

  • Nielsen BioSciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Harry S Nielsen, Ph.D. · Nielsen BioSciences, Inc.

  • Royce Johnson, M.D. · Kern Medical Center

  • Neil Ampel, M.D. · University of Arizona, Tucson

  • Brad Sawtelle, M.D. · Blair, NE

  • Stephen Kernerman, D.O. · Spokane, WA

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00690092 on ClinicalTrials.gov