A Phase 4 interventional study of Varicella Zoster Vaccine and Placebo in Psoriasis, sponsored by Innovaderm Research Inc.. Terminated at 3 sites in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Innovaderm Research Inc. · Phase 4, Interventional, and Prevention
This study will evaluate the ability of the vaccine to produce antibodies against herpes zoster virus (shingles) and safety of vaccination with Varicella Zoster Vaccine in patients with moderate to severe psoriasis who will initiate biologic therapy 4 to 6 weeks after vaccination.
Varicella Zoster Vaccine will be administered 4 to 6 weeks prior to receipt of biological therapy and will be compared against placebo.
This double-blind study will enroll approximately 50 adult patients with moderate-to-severe plaque psoriasis in approximately 3 centers in Canada. Study products will be assigned randomly at a 4:1 ratio.
For each patient who is included, the study may last up to 22 weeks, including the screening and the follow-up period. During the study, subjects will come to the dermatology clinic up to 4 occasions: for a screening visit, Baseline visit, Day 42 as well as 84 days after they started taking the biological treatment for a last visit. If patients develop a varicella-like or shingles-like rash at any time after they received the vaccine, they will be requested to come back to the clinic within 72 hours of rash onset (preferably within 24 hours) for examination. Subjects will be asked to provide a lesion swab/vesicular fluid in this case.
360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.
This study's enrollment of 3 is below the median of 250 across 299 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Innovaderm Research Inc. is the lead sponsor of 34 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
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.
Drug: Varicella Zoster Vaccine
United States Pharmacopeia (USP), preservative free for injection supplied in a single dose vial. A single dose will be administered to subjects at baseline.
Drug: Placebo
Also known as: Zostavax®
Also known as: 0.9% Sodium Chloride, Saline 0.9%
Varicella Zoster Virus (VZV) antibody
Geometric mean several fold rise in Varicella Zoster Virus (VZV) antibody from baseline to Day 42 as measured by glycoprotein-based enzyme-linked immunosorbent assay (gpELISA)
Time frame: 42 Days
Geometric mean titer of VZV antibody
Change from baseline in geometric mean titer of VZV antibody at Day 42 as measured with gpELISA.
Time frame: 42 Days
Serious Adverse Events
Proportion of patients randomized to Varicella Zoster Vaccine presenting vaccine related serious adverse events (SAEs) during the study as compared to patients randomized to placebo.
Time frame: 84 Days
Presenting with Varicella or Herpes Zoster
Proportion of patients randomized to Varicella Zoster Vaccine presenting varicella or herpes zoster during the study as compared to patients randomized to placebo
Time frame: 84 Days
Psoriasis Area Severity Index (PASI)
Change from baseline in Psoriasis Area Severity Index (PASI) at Day 84 post-biologic in patients randomized to Varicella Zoster Vaccine as compared to patients randomized to placebo.
Time frame: 84 Days
Body Surface Area (BSA)
Change from baseline in Body Surface Area (BSA) at Day 84 post-biologic in patients randomized to Varicella Zoster Vaccine as compared to patients randomized to placebo.
Time frame: 84 Days
Physician Global Assessment (PGA)
Change from baseline in Physician Global Assessment (PGA) at Day 84 post-biologic in patients randomized to Varicella Zoster Vaccine as compared to patients randomized to placebo.
Time frame: 84 Days
This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Innovaderm Research Inc.