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

Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.

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

Study Overview

• Status: Unknown
• Conditions: Tuberculosis Infection
• Intervention / Treatment: 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.

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Tyler, Texas, United States, 75708
      • Recruiting
      • The University of Texas Health Science Center at Tyler
      • Contact: Joe Santor, Pharm D.; Phone Number: 903-877-7632; Email: clin.res@uthct.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Confirm the potency of Aplisol equipotent to PPD-S2.	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess tolerability of Aplisol with new tuberculin PPD	72 hours

Collaborators and Investigators

• Sponsor: JHP Pharmaceuticals LLC
• Collaborators: Syneos Health

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ANTICIPATED): October 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (ESTIMATE): September 21, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 21, 2012
• Last Update Submitted That Met QC Criteria: September 18, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: JHP - 42023