Equivalence Study of Specificity of PPD

JHP Pharmaceuticals LLC152 enrolled

Overview

Determine if investigational products and reference standard produce similar responses.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

152

Conditions

Tuberculosis Infection

Interventions

Aplisol@ PPD materialBIOLOGICAL

Determine equivalency of materials

Reference StandardBIOLOGICAL

Reference standard material for comparison to newly produced materials.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \[as evidenced by a creatinine clearance \< 30 ml/min\])

Locations (1)

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Outcomes

Primary Outcomes

Determination of similarity in responses

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.Skin test responses will be used to determine product similarity in responses.

Time frame: 72 hours

Secondary Outcomes

Determine equivalent specificity

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 localand systemic reactogenicity events. Skin responses to new PPD and reference standard will be monitored to determine equivalent specificity.

Time frame: 72 hours

Central Contacts

Arlene Lund, B.Sc.

CONTACT

919-985-3220

Data from ClinicalTrials.gov

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