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Completed

NCT Number: NCT00690092

A Multi-center Study of Spherule-Derived Coccidioidin

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Health Sciences Center AVAHCS, Univ. of Arizona, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spherule-derived coccidioidin

Biological

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.

Other names: Coccidioidin SD (proposed trade name)

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.

    Time frame: 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.

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Nielsen BioSciences, Inc.

Industry

Collaborators

  • Sr Consultants Inc.

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 4, 2008
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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