Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)
NCT ID: NCT01689831
Last Updated: 2012-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
168 participants
INTERVENTIONAL
2012-05-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Aplisol, potency determination
To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
Reactivity of Aplisol compared to reference standard PPD-S2.
Reference standard PPD-S2 formulated to contain different dose concentrations.
Reference standard PPD-S2, reference
Reactivity of Aplisol compared to reference standard PPD-S2.
To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
Reactivity of Aplisol compared to reference standard PPD-S2.
Reference standard PPD-S2 formulated to contain different dose concentrations.
Interventions
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To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
Reactivity of Aplisol compared to reference standard PPD-S2.
Reference standard PPD-S2 formulated to contain different dose concentrations.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be accepted if medical records cannot be obtained.
3. Give written informed consent to participate
4. Generally healthy, as determined by medical history and targeted physical examination, if indicated
5. Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study preparation or the readings of the injections
6. Comprehension of the study requirements; expressed availability for the required study period, including readings at the nominal time points of 48 and 72 hours
Exclusion Criteria
2. Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
3. History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in the past
4. Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is uncertain of his/her BCG vaccination status
5. Presence of conditions that may suppress TST reactivity
18 Years
60 Years
ALL
Yes
Sponsors
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Syneos Health
OTHER
JHP Pharmaceuticals LLC
INDUSTRY
Responsible Party
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Locations
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The University of Texas Health Science Center at Tyler
Tyler, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Joe Santor, Pharm D.
Role: primary
Other Identifiers
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JHP - 42023
Identifier Type: -
Identifier Source: org_study_id