Tuberculosis Infection
Conditions
Keywords
TB, Aplisol
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.
Interventions
BIOLOGICALAplisol@ PPD material
Determine equivalency of materials
BIOLOGICALReference Standard
Reference standard material for comparison to newly produced materials.
Sponsors
Syneos Health
JHP Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
* 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 \[as evidenced by a creatinine clearance \< 30 ml/min\])
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of similarity in responses | 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
| Measure | Time frame | Description |
|---|---|---|
| Determine equivalent specificity | 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. |
Countries
United States
Contacts
Primary ContactArlene Lund, B.Sc.
Outcome results
None listed