Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)
Status unconfirmed · Phase 2
Conditions studied: Tuberculosis Infection
In brief
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).
Key facts
- Study ID
- NCT01689831
- Run by
- JHP Pharmaceuticals LLC
- People needed
- 168
- Starts
- 2012-05-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2012-09-21
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The University of Texas Health Science Center at Tyler — Tyler, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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