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Status unknownNCT0179809503Updated Feb 25, 2013

Equivalence Study of Specificity of PPD

A Phase 2 interventional study of Aplisol@ PPD material and Reference Standard in Tuberculosis Infection, sponsored by JHP Pharmaceuticals LLC. Status unknown at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-25.

Sponsored by JHP Pharmaceuticals LLC · Phase 2, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Determine if investigational products and reference standard produce similar responses.

Read the 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.
02

Conditions studied

  • Tuberculosis Infection

Keywords

  • TB, Aplisol
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's planned enrollment of 152 is close to the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

JHP Pharmaceuticals LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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])
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
152 participants (estimated)

Study arms

  • Experimental
    Aplisol

    To confirm the response of PPD materials

    Biological: Aplisol@ PPD material · Biological: Reference Standard

  • Active comparator
    PPD Standard

    Determine equivalent specificity for new material compared to standard material.

    Biological: Aplisol@ PPD material · Biological: Reference Standard

Interventions

  • BiologicalAplisol@ PPD material

    Determine equivalency of materials

    Also known as: Aplisol@

  • BiologicalReference Standard

    Reference standard material for comparison to newly produced materials.

    Also known as: US Reference Standard

06

What researchers measure

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.

    Time frame: 72 hours

Secondary outcomes

  1. 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.

    Time frame: 72 hours

07

Study locations

1 site
  • The University of Texas Health Science Center at Tyler
    Tyler, Texas 75708, United States
    • Joe Santor, Pharm. D. · Contact · clin.res@uthct.edu · 903-877-7632
    • David Griffith, M.D. · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01798095
Lead sponsor
JHP Pharmaceuticals LLC
Collaborators
Syneos Health
Responsible party
Sponsor
First posted
Feb 25, 2013
Start date
Feb 2013
Primary completion
May 2013 (estimated)
Completion
Jul 2013 (estimated)
Last update
Feb 25, 2013

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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