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

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

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