Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)
Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.
1 other identifier
interventional
168
1 country
1
Brief Summary
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 3, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 21, 2012
September 1, 2012
5 months
July 3, 2012
September 18, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Confirm the potency of Aplisol equipotent to PPD-S2.
72 hours
Secondary Outcomes (1)
Assess tolerability of Aplisol with new tuberculin PPD
72 hours
Study Arms (2)
Aplisol, potency determination
EXPERIMENTALTo confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
Reference standard PPD-S2, reference
ACTIVE COMPARATORReactivity of Aplisol compared to reference standard PPD-S2.
Interventions
Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
Reference standard PPD-S2 formulated to contain different dose concentrations.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JHP Pharmaceuticals LLClead
- Syneos Healthcollaborator
Study Sites (1)
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2012
First Posted
September 21, 2012
Study Start
May 1, 2012
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
September 21, 2012
Record last verified: 2012-09