Equivalence Study of Specificity of PPD

Status unconfirmed · Phase 2

Conditions studied: Tuberculosis Infection

In brief

Determine if investigational products and reference standard produce similar responses.

Key facts

Study ID

NCT01798095

Run by

JHP Pharmaceuticals LLC

People needed

152

Starts

2013-02-01

Expected to finish

2013-07-01

Last updated by the study team

2013-02-25

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 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

You may not qualify if…

• 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])

Where it is running

• The University of Texas Health Science Center at Tyler — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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