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

Study Overview
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Brief Summary
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A study to determine bioequivalence of PPD material versus Reference Standard.

Detailed Description
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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).

Official Title
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A Randomized, Double-blind, Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard Tuberculin Purified Protein Derivative (PPD-S2) for Detection of Tuberculosis in Subjects With a Confirmed Diagnosis of Tuberculosis.

Conditions
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Tuberculosis Identification.

Intervention / Treatment
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* Biological: To compare new PPD to reference standard material
* Biological: Reference standard


Participation Criteria
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Eligibility Criteria
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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 acc 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 prepar Comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina 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 Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is Presence of conditions that may suppress TST reactivity -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aplisol<br>To compare new PPD to reference standard material | Biological: To compare new PPD to reference standard material<br>* Aplisol@ will be compared to reference standard material<br>* Other names: Aplisol@;Biological: Reference standard<br>* Response of reference standard material compared to Aplisol@.<br>* Other names: Tuberculin PPD Standard.;|
| Placebo Comparator: Reference standard<br>Response of standard material | Biological: To compare new PPD to reference standard material<br>* Aplisol@ will be compared to reference standard material<br>* Other names: Aplisol@;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare new PPD to Reference Standard | Determine bio-equivalence of material used in trial by means of dose response and reaction sizes in patients. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPD, Tuberculosis