Clinical trial NCT01798095: Equivalence Study of Specificity of PPD
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tuberculosis Infection
Keywords: TB, Aplisol
Lead sponsor: JHP Pharmaceuticals LLC
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2013-02-25
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Determination of similarity in responses
timeFrame: 72 hours
Secondary outcomes:
measure: Determine equivalent specificity
timeFrame: 72 hours
Other outcomes:
Locations:
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
Study officials:
References: