Varicella Zoster Vaccine in Patients With Plaque Psoriasis Treated With Biologic Therapy
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|ClinicalTrials.gov Identifier: NCT02408159|
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : April 3, 2015
Last Update Posted : July 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Varicella Zoster Vaccine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||March 2017|
Experimental: Varicella Zoster Vaccine
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
Other Name: Zostavax®
Placebo Comparator: 0.9% Sodium Chloride
United States Pharmacopeia (USP), preservative free for injection supplied in a single dose vial.
A single dose will be administered to subjects at baseline.
- Varicella Zoster Virus (VZV) antibody [ Time Frame: 42 Days ]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)
- Geometric mean titer of VZV antibody [ Time Frame: 42 Days ]Change from baseline in geometric mean titer of VZV antibody at Day 42 as measured with gpELISA.
- Serious Adverse Events [ Time Frame: 84 Days ]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.
- Presenting with Varicella or Herpes Zoster [ Time Frame: 84 Days ]Proportion of patients randomized to Varicella Zoster Vaccine presenting varicella or herpes zoster during the study as compared to patients randomized to placebo
- Psoriasis Area Severity Index (PASI) [ Time Frame: 84 Days ]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.
- Body Surface Area (BSA) [ Time Frame: 84 Days ]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.
- Physician Global Assessment (PGA) [ Time Frame: 84 Days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408159
|Inno-6041 study site|
|London, Ontario, Canada|
|Inno-6041 study site|
|Markham, Ontario, Canada|
|Innovaderm Research Inc.|
|Montreal, Quebec, Canada, H2K 4L5|
|Principal Investigator:||Lyn Guenther, MD, FRCPC||The Guenther Dermatology Research Center|