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Equivalence Study of Specificity of PPD (03)

Primary Purpose

Tuberculosis Infection

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Aplisol@ PPD material

Reference Standard

About this trial

This is an interventional diagnostic trial for Tuberculosis Infection focused on measuring TB, Aplisol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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])

Sites / Locations

The University of Texas Health Science Center at Tyler

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aplisol

PPD Standard

Arm Description

To confirm the response of PPD materials

Determine equivalent specificity for new material compared to standard material.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01798095

First Posted

January 31, 2013

Last Updated

February 21, 2013

Sponsor

JHP Pharmaceuticals LLC

Collaborators

Syneos Health

1. Study Identification

Unique Protocol Identification Number

NCT01798095

Brief Title

Equivalence Study of Specificity of PPD

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (undefined)

Primary Completion Date

May 2013 (Anticipated)

Study Completion Date

July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

JHP Pharmaceuticals LLC

Collaborators

Syneos Health

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis Infection

Keywords

TB, Aplisol

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aplisol

Arm Type

Experimental

Arm Description

To confirm the response of PPD materials

Arm Title

PPD Standard

Arm Type

Active Comparator

Arm Description

Determine equivalent specificity for new material compared to standard material.

Intervention Type

Biological

Intervention Name(s)

Aplisol@ PPD material

Other Intervention Name(s)

Aplisol@

Intervention Description

Determine equivalency of materials

Intervention Type

Biological

Intervention Name(s)

Reference Standard

Other Intervention Name(s)

US Reference Standard

Intervention Description

Reference standard material for comparison to newly produced materials.

Primary Outcome Measure Information:

Title

Determination of similarity in responses

Description

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Determine equivalent specificity

Description

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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])

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arlene Lund, B.Sc.

Phone

919-985-3220

Facility Information:

Facility Name

The University of Texas Health Science Center at Tyler

City

Tyler

State/Province

Texas

ZIP/Postal Code

75708

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joe Santor, Pharm. D.

Phone

903-877-7632

clin.res@uthct.edu

First Name & Middle Initial & Last Name & Degree

David Griffith, M.D.

12. IPD Sharing Statement

Learn more about this trial

Equivalence Study of Specificity of PPD

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