CoccidioidomycosisPhase 3NCT00690092
A Multi-center Study of Spherule-Derived Coccidioidin
A Phase 3 study testing Spherule-derived coccidioidin in people with Coccidioidomycosis, run by Nielsen BioSciences, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coccidioidomycosis
- What is being tested?
- Spherule-derived coccidioidin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2005to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kern Facility Medical Group
Bakersfield, California, 93306
Blair Clinic
Blair, Nebraska, 68001
Spokane Allergy and Asthma Center
Spokane, Washington, 99204
Health Sciences Center AVAHCS, Univ. of Arizona
Tucson, Arizona, 85723
About this study
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
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
- Being tested
- Spherule-derived coccidioidin
- Keywords
- Coccidioidin, Coccidioidin SD, Spherule-derived coccidioidin, Coccidioidomycosis, Valley Fever, Coccidioides immitis
- Medical subject headings
- Coccidioidomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spherule-derived coccidioidinBiological
Also called Coccidioidin SD (proposed trade name)
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology. Receives: Biological: Spherule-derived coccidioidin |
| 2 | Active comparator | Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive). Receives: Biological: Spherule-derived coccidioidin |
| 3 | Active comparator | Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology. Receives: Biological: Spherule-derived coccidioidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startMay 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccidioidomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nielsen BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sr Consultants Inc.
- Investigators
- Harry S Nielsen, Ph.D., Study director, Nielsen BioSciences, Inc.Royce Johnson, M.D., Principal investigator, Kern Medical CenterNeil Ampel, M.D., Principal investigator, University of Arizona, TucsonBrad Sawtelle, M.D., Principal investigator, Blair, NEStephen Kernerman, D.O., Principal investigator, Spokane, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690092
- Sponsor's protocol ID
- S104-1, S104-2, S104-3
- Status last verified
- Oct 2013
- First submitted
- 2 Jun 2008
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00690092
- Acronym / sponsor ID
- S104-1, S104-2, S104-3
- Conditions
- Coccidioidomycosis
- Keywords
- Coccidioidin, Coccidioidin SD, Spherule-derived coccidioidin, Coccidioidomycosis, Valley Fever, Coccidioides immitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Nielsen BioSciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sr Consultants Inc.
- Study start
- May 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Spherule-derived coccidioidinVolunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology. |
| 2 | Active comparator | Biological: Spherule-derived coccidioidinVolunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive). |
| 3 | Active comparator | Biological: Spherule-derived coccidioidinVolunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Good Health (absence of active medical disease)
- Meets criteria specific to population groups:
- History of coccidioidomycosis of at least 45 days duration confirmed by roentgenograph serologic or mycologic findings
- History of pulmonary histoplasmosis
- Lifetime residence in the states of WA, OR, ID, or MT
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spherule-derived coccidioidinAlso: Coccidioidin SD (proposed trade name)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. | Biological | 1, 2, 3 |
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.
Time frame: 48 hours
1 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.
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry S Nielsen, Ph.D. study director
Nielsen BioSciences, Inc.
Royce Johnson, M.D. principal investigator
Kern Medical Center
Neil Ampel, M.D. principal investigator
University of Arizona, Tucson
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spherule-derived coccidioidin in people with Coccidioidomycosis, run by Nielsen BioSciences, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.