Status:
UNKNOWN
Equivalence Study of Specificity of PPD
Lead Sponsor:
JHP Pharmaceuticals LLC
Collaborating Sponsors:
Syneos Health
Conditions:
Tuberculosis Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Determine if investigational products and reference standard produce similar responses.
Detailed Description
Primary: To determine if the 2 investigational products (Aplisol formulated from the new Tuberculin PPD drug substance and the reference standard PPD-S2) produce qualitatively similar responses (posi...
Eligibility Criteria
Inclusion
- Males or nonpregnant females, age 18 to 70 years
- Negligible risk of manifesting a positive PPD test as evidenced by:
- Prior history of negative PPD test or interferon gamma release assay (IGRA) within 14 months before Screening
- No history of Bacillus Calmette- Guérin vaccination; or if vaccination status is uncertain, was born in the US and did not live outside the US as a child
- No history of Mtb or Mtb therapy (including isoniazid, rifampin, ethambutol, pyrazinamide, or streptomycin)
- No history of infection with atypical mycobacteria, including suspicious chest roentgenogram
- No history of high risk medical conditions (eg, HIV infection or other immunosuppressive conditions, severe chronic renal disease \[as evidenced by a creatinine clearance \< 30 ml/min\], poorly controlled diabetes mellitus, silicosis, intravenous drug use, or alcohol abuse)
- No known close contact to a confirmed Mtb case (family or social setting)
- No history of living or travelling in India, China, Sub-Saharan Africa, or Southeast Asia in the past 6 months
- No exposure (other than casual) to high-risk environments for Mtb exposure (eg, prisons, homeless shelters); healthcare workers are allowed
Exclusion
- Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
- History of anaphylactic type reaction or other severe reaction to PPD in the past, including a history of blistering or sloughing
- Presence of conditions that may suppress TST reactivity, including:
- Protocol No. JHP-Aplisol-03 Confidential 04 May 2012 Page 8 of 38
- Acute viral infections, including measles, mumps, chicken pox, human immunodeficiency virus (HIV1, HIV2). Mild viral syndromes are allowed.
- Acute bacterial infections including typhoid fever, brucellosis, typhus, leprosy, or pertussis
- Acute systemic fungal infection
- Live virus vaccinations within the past 6 weeks, including measles, mumps, polio, varicella, or FluMist®
- Metabolic derangements (eg, poorly controlled diabetes, Cushing syndrome, chronic renal failure \[as evidenced by a creatinine clearance \< 30 ml/min\])
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT01798095
Start Date
February 1 2013
End Date
July 1 2013
Last Update
February 25 2013
Active Locations (1)
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1
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708