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

Primary Purpose

Tuberculosis Infection

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
Reactivity of Aplisol compared to reference standard PPD-S2.
Sponsored by
JHP Pharmaceuticals LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tuberculosis Infection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at TylerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aplisol, potency determination

Reference standard PPD-S2, reference

Arm Description

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

Reactivity of Aplisol compared to reference standard PPD-S2.

Outcomes

Primary Outcome Measures

Confirm the potency of Aplisol equipotent to PPD-S2.

Secondary Outcome Measures

Assess tolerability of Aplisol with new tuberculin PPD

Full Information

First Posted
July 3, 2012
Last Updated
September 18, 2012
Sponsor
JHP Pharmaceuticals LLC
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT01689831
Brief Title
Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)
Official Title
Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JHP Pharmaceuticals LLC
Collaborators
Syneos Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).
Detailed Description
JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aplisol, potency determination
Arm Type
Experimental
Arm Description
To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
Arm Title
Reference standard PPD-S2, reference
Arm Type
Active Comparator
Arm Description
Reactivity of Aplisol compared to reference standard PPD-S2.
Intervention Type
Biological
Intervention Name(s)
To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
Intervention Description
Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
Intervention Type
Biological
Intervention Name(s)
Reactivity of Aplisol compared to reference standard PPD-S2.
Other Intervention Name(s)
Reference standard PPD-S2.
Intervention Description
Reference standard PPD-S2 formulated to contain different dose concentrations.
Primary Outcome Measure Information:
Title
Confirm the potency of Aplisol equipotent to PPD-S2.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Assess tolerability of Aplisol with new tuberculin PPD
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males or nonpregnant females age 18 to 60 years 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. Give written informed consent to participate Generally healthy, as determined by medical history and targeted physical examination, if indicated 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 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: Prior PPD test within the past 30 days Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in the past 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 Presence of conditions that may suppress TST reactivity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyndy Hughes
Phone
919-876-9300
Email
Cyndy.Hughes@INCResearch.com
Facility Information:
Facility Name
The University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joe Santor, Pharm D.
Phone
903-877-7632
Email
clin.res@uthct.edu
First Name & Middle Initial & Last Name & Degree
David Griffith, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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