Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2)

Phase 2

• Conditions: Tuberculosis Identification.
• Interventions: Biological: To compare new PPD to reference standard material; Biological: Reference standard

• Registration Number: NCT01798121
• Lead Sponsor: JHP Pharmaceuticals LLC

Brief Summary

A study to determine bioequivalence of PPD material versus Reference Standard.

Detailed Description

This study is a multicenter, double-blind, active-controlled parallel-group study to determine the bioequivalence of newly produced PPD material versus PPD-S2 in the detection of male and female subjects with current or previously diagnosed intrathoracic Mtb infection, as documented by a positive culture for Mtb (preferred method), by their primary care or attending physician and/or by the subject's current or prior medical records (ie, sensitivity determination).

Study Timeline

• Study First Submitted: 2013-01-31
• Status Verified: 2013-02
• Study Start: 2013-02
• Study First Submitted QC: 2013-02-21
• Last Update Submitted: 2013-02-21
• Study First Posted: 2013-02-25
• Last Update Posted: 2013-02-25
• Primary Completion: 2013-03
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 acc
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 prepar
6. Comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina

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
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
5. Presence of conditions that may suppress TST reactivity -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aplisol	To compare new PPD to reference standard material	To compare new PPD to reference standard material
Aplisol	Reference standard	To compare new PPD to reference standard material
Reference standard	To compare new PPD to reference standard material	Response of standard material

Primary Outcome Measures

Name	Time	Method
Compare new PPD to Reference Standard	72 hours	Determine bio-equivalence of material used in trial by means of dose response and reaction sizes in patients.