Equivalence Study of Specificity of PPD

Tuberculosis Infection Clinical Trial

— 03  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01798095
• Other study ID #: JHP-03
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 31, 2013
• Last updated: February 21, 2013
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: February 2013
• Source: JHP Pharmaceuticals LLC
• Contact: Arlene Lund, B.Sc.
• Phone: 919-985-3220
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Determine if investigational products and reference standard produce similar responses.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis Infection

Intervention

Biological:
• Aplisol@ PPD material
Determine equivalency of materials
• Reference Standard
Reference standard material for comparison to newly produced materials.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Tyler	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
JHP Pharmaceuticals LLC	INC Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No