Equivalence Study of Specificity of PPD

NCT ID: NCT01798095

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-07-31

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.

Conditions

Tuberculosis Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Aplisol

To confirm the response of PPD materials

Group Type: EXPERIMENTAL

Aplisol@ PPD material

Intervention Type: BIOLOGICAL

Determine equivalency of materials

Reference Standard

Intervention Type: BIOLOGICAL

Reference standard material for comparison to newly produced materials.

PPD Standard

Determine equivalent specificity for new material compared to standard material.

Group Type: ACTIVE_COMPARATOR

Aplisol@ PPD material

Intervention Type: BIOLOGICAL

Determine equivalency of materials

Reference Standard

Intervention Type: BIOLOGICAL

Reference standard material for comparison to newly produced materials.

Interventions

Aplisol@ PPD material

Determine equivalency of materials

Intervention Type: BIOLOGICAL

Reference Standard

Reference standard material for comparison to newly produced materials.

Intervention Type: BIOLOGICAL

Other Intervention Names

Aplisol@; US Reference Standard

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])

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

JHP Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Countries

United States

Central Contacts

Arlene Lund, B.Sc.

Role: CONTACT

919-985-3220

Facility Contacts

Joe Santor, Pharm. D.

Role: primary

clin.res@uthct.edu

903-877-7632

Other Identifiers

JHP-03

Identifier Type: -

Identifier Source: org_study_id