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

Information source: JHP Pharmaceuticals LLC
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tuberculosis Infection

Intervention: 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. (Biological)

Phase: Phase 2

Status: Recruiting

Sponsored by: JHP Pharmaceuticals LLC

Overall contact:
Cyndy Hughes, Phone: 919-876-9300, Email: Cyndy.Hughes@INCResearch.com

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Primary outcome: Confirm the potency of Aplisol equipotent to PPD-S2.

Secondary outcome: Assess tolerability of Aplisol with new tuberculin PPD

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

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Cyndy Hughes, Phone: 919-876-9300, Email: Cyndy.Hughes@INCResearch.com

The University of Texas Health Science Center at Tyler, Tyler, Texas 75708, United States; Recruiting
Joe Santor, Pharm D., Phone: 903-877-7632, Email: clin.res@uthct.edu
David Griffith, M.D., Principal Investigator
Additional Information

Starting date: May 2012
Last updated: September 18, 2012

Page last updated: February 07, 2013

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