Equivalence Study of Specificity of PPD

NCT01798095 | Unknown Phase 2

• 1 other identifier: JHP-03
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Determine if investigational products and reference standard produce similar responses.

Conditions

Tuberculosis Infection

Keywords

TB, Aplisol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine equivalent specificity

  72 hours

Study Arms (2)

Aplisol

EXPERIMENTAL

To confirm the response of PPD materials

Biological: Aplisol@ PPD material; Biological: Reference Standard

PPD Standard

ACTIVE COMPARATOR

Determine equivalent specificity for new material compared to standard material.

Biological: Aplisol@ PPD material; Biological: Reference Standard

Interventions

Aplisol@ PPD material BIOLOGICAL

Determine equivalency of materials

Also known as: Aplisol@

Aplisol; PPD Standard

Reference Standard BIOLOGICAL

Reference standard material for comparison to newly produced materials.

Also known as: US Reference Standard

Aplisol; PPD Standard

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 \[as evidenced by a creatinine clearance \< 30 ml/min\])

Sponsors & Collaborators

• JHP Pharmaceuticals LLC: lead
• Syneos Health: collaborator

Study Sites (1)

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Tuberculin; Reference Standards

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors; Weights and Measures; Investigative Techniques

Central Study Contacts

Arlene Lund, B.Sc.

CONTACT

919-985-3220

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 25, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

US (1)