Varicella Zoster Vaccine in Patients With Plaque Psoriasis Treated With Biologic Therapy
Psoriasis
About this trial
This is an interventional prevention trial for Psoriasis focused on measuring Live, attenuated virus varicella-zoster vaccine, Zostavax, herpes zoster, shingles
Eligibility Criteria
Main Inclusion Criteria:
- Outpatient men or women aged 50 years or older
- Must have moderate-to-severe plaque psoriasis for at least 6 months, and for whom a decision to use biologic therapy has been made, with biologic therapy planned to be initiated within the next 4-6 weeks.
- History of varicella, or having resided in Canada for at least 30 years.
Main Exclusion Criteria:
- Have received Varicella Zoster Vaccine vaccine or known allergies to the Varicella Zoster Vaccine vaccine or its excipients including neomycin and gelatin
- Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukemias, lymphoma, other conditions affecting the bone marrow or lymphatic system, immunosuppression due to HIV/AIDS, cellular immune deficiencies.
- Current use of non-topical antiviral therapy with known activity against varicella-zoster virus.
- Exposure to varicella or zoster within 28 days prior to vaccination.
- Patients who are diagnosed with herpes zoster at the time of the vaccination.
- Active untreated tuberculosis.
Sites / Locations
- Inno-6041 study site
- Inno-6041 study site
- Innovaderm Research Inc.
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Varicella Zoster Vaccine
0.9% Sodium Chloride
Sterile, lyophilized white to off-white compact crystalline plug in a single-dose vial. Each vial contains one dose of lyophilized vaccine (approximately 0.65 mL when reconstituted as directed). The diluent (0.7 mL) is a sterile, clear, colorless fluid supplied separately in a 3 mL single-dose vial. A single dose will be administered to subjects at baseline.
United States Pharmacopeia (USP), preservative free for injection supplied in a single dose vial. A single dose will be administered to subjects at baseline.