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Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)

Sponsor
JHP Pharmaceuticals LLC (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01689831
Collaborator
Syneos Health (Other)
168
Enrollment
1
Location
2
Arms
7
Duration (Months)
23.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).

Condition or Disease Intervention/Treatment Phase
  • Biological: To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
  • Biological: Reactivity of Aplisol compared to reference standard PPD-S2.
 Phase 2

Detailed Description

JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Diagnostic
Official Title:
Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.
Study Start Date :
May 1, 2012
Anticipated Primary Completion Date :
Oct 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aplisol, potency determination

To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.

Biological: 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.

Biological: Reactivity of Aplisol compared to reference standard PPD-S2.
Reference standard PPD-S2 formulated to contain different dose concentrations.
Other Names:
  • Reference standard PPD-S2.

    		•
    Active Comparator: Reference standard PPD-S2, reference

    Reactivity of Aplisol compared to reference standard PPD-S2.

    Biological: 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.

    Biological: Reactivity of Aplisol compared to reference standard PPD-S2.
    Reference standard PPD-S2 formulated to contain different dose concentrations.
    Other Names:
  • Reference standard PPD-S2.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Confirm the potency of Aplisol equipotent to PPD-S2. [72 hours]

    Secondary Outcome Measures

    1. Assess tolerability of Aplisol with new tuberculin PPD [72 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Males or nonpregnant females age 18 to 60 years

    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:

    1. Prior PPD test within the past 30 days

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas Health Science Center at Tyler Tyler Texas United States 75708

    Sponsors and Collaborators

    • JHP Pharmaceuticals LLC
    • Syneos Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JHP Pharmaceuticals LLC
    ClinicalTrials.gov Identifier:
    NCT01689831
    Other Study ID Numbers:
    • JHP - 42023
    First Posted:
    Sep 21, 2012
    Last Update Posted:
    Sep 21, 2012
    Last Verified:
    Sep 1, 2012
    Additional relevant MeSH terms:
    Tuberculosis
    Latent Tuberculosis

    Study Results

    No Results Posted as of Sep 21, 2012