Psoriasis Clinical Trial
Official title:
A Double Blind Placebo-controlled Randomized Study of Varicella Zoster Vaccine in Patients With Moderate-to-severe Plaque Psoriasis Who Are Candidates for Biologic Therapy
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.
n/a
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