03A Randomized, Double-blind, Equivalence Study of the Specificity of Tuberculin Purified Protein Derivative (PPD) (Aplisol®) in Comparison With a Reference Standard

Study start date: February 1, 2013

Inclusion Criteria: 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 Criteria: 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])