Equivalence Study of Specificity of PPD

Phase 2

• Conditions: Tuberculosis Infection
• Interventions: Biological: Aplisol@ PPD material; Biological: Reference Standard

• Registration Number: NCT01798095
• Lead Sponsor: JHP Pharmaceuticals LLC

Brief Summary

Determine if investigational products and reference standard produce similar responses.

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 Timeline

• Study First Submitted: 2013-01-31
• Status Verified: 2013-02
• Study Start: 2013-02
• Study First Submitted QC: 2013-02-21
• Last Update Submitted: 2013-02-21
• Study First Posted: 2013-02-25
• Last Update Posted: 2013-02-25
• Primary Completion: 2013-05
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aplisol	Aplisol@ PPD material	To confirm the response of PPD materials
Aplisol	Reference Standard	To confirm the response of PPD materials
PPD Standard	Aplisol@ PPD material	Determine equivalent specificity for new material compared to standard material.
PPD Standard	Reference Standard	Determine equivalent specificity for new material compared to standard material.

Primary Outcome Measures

Name	Time	Method
Determination of similarity in responses	72 hours	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.

Secondary Outcome Measures

Name	Time	Method
Determine equivalent specificity	72 hours	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Tyler; 🇺🇸 Tyler, Texas, United States