Equivalence Study of Specificity of PPD (03)

JHP Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Tuberculosis Infection

Treatments: Biological: Reference Standard; Biological: Aplisol@ PPD material

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01798095

JHP-03

Details and patient eligibility

About

Determine if investigational products and reference standard produce similar responses.

Full 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 (positive or negative) in subjects who are uninfected with M. tuberculosis (Mtb) or other mycobacteria.

Secondary:

1. To determine if the 2 investigational products have equivalent specificity for detecting subjects currently or previously infected with Mtb;
2. To assess the tolerability of the investigational products in terms of the local and systemic reactogenicity events.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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])

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups

Aplisol

Experimental group

Description:

To confirm the response of PPD materials

Treatment:

Biological: Aplisol@ PPD material

Biological: Reference Standard

PPD Standard

Active Comparator group

Description:

Determine equivalent specificity for new material compared to standard material.

Treatment:

Biological: Aplisol@ PPD material

Biological: Reference Standard