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

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

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

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

Conditions
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Tuberculosis Infection

Intervention / Treatment
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* 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.


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 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

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

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aplisol, potency determination<br>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.<br>* Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.<br>Biological: Reactivity of Aplisol compared to reference standard PPD-S2.<br>* Reference standard PPD-S2 formulated to contain different dose concentrations.<br>* Other names: Reference standard PPD-S2.;|
| Active Comparator: Reference standard PPD-S2, reference<br>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.<br>* Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.<br>Biological: Reactivity of Aplisol compared to reference standard PPD-S2.<br>* Reference standard PPD-S2 formulated to contain different dose concentrations.<br>* Other names: Reference standard PPD-S2.;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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