Varicella Zoster Vaccine in Patients With Plaque Psoriasis Treated With Biologic Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: Varicella Zoster Vaccine

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • Inno-6041 study site
    • Markham, Ontario, Canada
      • Inno-6041 study site
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Innovaderm Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

1. Outpatient men or women aged 50 years or older
2. 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.
3. History of varicella, or having resided in Canada for at least 30 years.

Main Exclusion Criteria:

1. Have received Varicella Zoster Vaccine vaccine or known allergies to the Varicella Zoster Vaccine vaccine or its excipients including neomycin and gelatin
2. 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.
3. Current use of non-topical antiviral therapy with known activity against varicella-zoster virus.
4. Exposure to varicella or zoster within 28 days prior to vaccination.
5. Patients who are diagnosed with herpes zoster at the time of the vaccination.
6. Active untreated tuberculosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.	Drug: Placebo; Other Names: 0.9% Sodium Chloride; Saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	42 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean titer of VZV antibody	Change from baseline in geometric mean titer of VZV antibody at Day 42 as measured with gpELISA.	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.	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	84 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	84 Days

Collaborators and Investigators

• Sponsor: Innovaderm Research Inc.
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Lyn Guenther, MD, FRCPC, The Guenther Dermatology Research center

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (ESTIMATE): April 3, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: herpes zoster; shingles; Zostavax; Live, attenuated virus varicella-zoster vaccine
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Papulosquamous; Herpesviridae Infections; Varicella Zoster Virus Infection; Psoriasis; Herpes Zoster; Chickenpox
• Other Study ID Numbers: Inno-6041