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Equivalence Study of Specificity of PPD (03)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798095
Recruitment Status : Unknown
Verified February 2013 by JHP Pharmaceuticals LLC.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2013
Last Update Posted : February 25, 2013
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
JHP Pharmaceuticals LLC

Brief Summary:
Determine if investigational products and reference standard produce similar responses.

Condition or disease Intervention/treatment Phase
Tuberculosis Infection Biological: Aplisol@ PPD material Biological: Reference Standard Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
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 Start Date : February 2013
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: Aplisol
To confirm the response of PPD materials
Biological: Aplisol@ PPD material
Determine equivalency of materials
Other Name: Aplisol@

Biological: Reference Standard
Reference standard material for comparison to newly produced materials.
Other Name: US Reference Standard

Active Comparator: PPD Standard
Determine equivalent specificity for new material compared to standard material.
Biological: Aplisol@ PPD material
Determine equivalency of materials
Other Name: Aplisol@

Biological: Reference Standard
Reference standard material for comparison to newly produced materials.
Other Name: US Reference Standard




Primary Outcome Measures :
  1. Determination of similarity in responses [ Time Frame: 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 :
  1. Determine equivalent specificity [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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])

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798095


Contacts
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Contact: Arlene Lund, B.Sc. 919-985-3220

Locations
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United States, Texas
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708
Contact: Joe Santor, Pharm. D.    903-877-7632    clin.res@uthct.edu   
Principal Investigator: David Griffith, M.D.         
Sponsors and Collaborators
JHP Pharmaceuticals LLC
Syneos Health
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Responsible Party: JHP Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01798095    
Other Study ID Numbers: JHP-03
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013
Keywords provided by JHP Pharmaceuticals LLC:
TB, Aplisol
Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections