Tuberculosis Infection
Conditions
Brief summary
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).
Detailed description
JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.
Interventions
BIOLOGICALTo confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
BIOLOGICALReactivity of Aplisol compared to reference standard PPD-S2.
Reference standard PPD-S2 formulated to contain different dose concentrations.
Sponsors
Syneos Health
JHP Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirm the potency of Aplisol equipotent to PPD-S2. | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Assess tolerability of Aplisol with new tuberculin PPD | 72 hours |
Countries
United States
Contacts
Primary ContactCyndy Hughes
Outcome results
None listed