Equivalence Study of Specificity of PPD (03)

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

Determine if investigational products and reference standard produce similar responses.

Study Overview

• Status: Unknown
• Conditions: Tuberculosis Infection
• Intervention / Treatment: Biological: Aplisol@ PPD material; Biological: Reference Standard

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 (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
• Enrollment (Anticipated): 152
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Arlene Lund, B.Sc.; Phone Number: 919-985-3220

Study Locations

• United States
  • Texas
    • Tyler, Texas, United States, 75708
      • The University of Texas Health Science Center at Tyler
      • Contact: Joe Santor, Pharm. D.; Phone Number: 903-877-7632; Email: clin.res@uthct.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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])

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aplisol; To confirm the response of PPD materials	Biological: Aplisol@ PPD material; Determine equivalency of materials; Other Names: Aplisol@; Biological: Reference Standard; Reference standard material for comparison to newly produced materials.; Other Names: US Reference Standard
Active Comparator: PPD Standard; Determine equivalent specificity for new material compared to standard material.	Biological: Aplisol@ PPD material; Determine equivalency of materials; Other Names: Aplisol@; Biological: Reference Standard; Reference standard material for comparison to newly produced materials.; Other Names: US Reference Standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours

Collaborators and Investigators

• Sponsor: JHP Pharmaceuticals LLC
• Collaborators: Syneos Health

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 25, 2013

Study Record Updates

• Last Update Posted (Estimate): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: TB, Aplisol
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: JHP-03