A Multi-center Study of Spherule-Derived Coccidioidin

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

 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.

Condition

Coccidioidomycosis

Intervention

Spherule-derived coccidioidin

Study Arms / Comparison Groups

 1
Description:  Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

113

Start Date

May 2005

Completion Date

September 2007

Primary Completion Date

September 2007

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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Harry S Nielsen, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00690092

Organization ID

S104-1, S104-2, S104-3



Study Sponsor

Nielsen BioSciences, Inc.

Collaborators

 Sr Consultants Inc.

Study Sponsor

Harry S Nielsen, Ph.D., Study Director, Nielsen BioSciences, Inc.


Verification Date

October 2013