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

JHP Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Tuberculosis Infection

Treatments: Biological: 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.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01689831

JHP - 42023

Details and patient eligibility

About

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

Full description

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

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups

Aplisol, potency determination

Experimental group

Description:

To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.

Treatment:

Biological: 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.

Reference standard PPD-S2, reference

Active Comparator group

Description:

Reactivity of Aplisol compared to reference standard PPD-S2.

Treatment:

Biological: 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.