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

Primary Purpose

Psoriasis

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Varicella Zoster Vaccine
Placebo
Sponsored by
Innovaderm Research Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Inno-6041 study site
  • Inno-6041 study site
  • Innovaderm Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Varicella Zoster Vaccine

0.9% Sodium Chloride

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Geometric mean titer of VZV antibody
Change from baseline in geometric mean titer of VZV antibody at Day 42 as measured with gpELISA.
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.
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

Full Information

First Posted
March 31, 2015
Last Updated
June 29, 2017
Sponsor
Innovaderm Research Inc.
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02408159
Brief Title
Varicella Zoster Vaccine in Patients With Plaque Psoriasis Treated With Biologic Therapy
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovaderm Research Inc.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Live, attenuated virus varicella-zoster vaccine, Zostavax, herpes zoster, shingles

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varicella Zoster Vaccine
Arm Type
Experimental
Arm Description
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.
Arm Title
0.9% Sodium Chloride
Arm Type
Placebo Comparator
Arm Description
United States Pharmacopeia (USP), preservative free for injection supplied in a single dose vial. A single dose will be administered to subjects at baseline.
Intervention Type
Drug
Intervention Name(s)
Varicella Zoster Vaccine
Other Intervention Name(s)
Zostavax®
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% Sodium Chloride, Saline 0.9%
Primary Outcome Measure Information:
Title
Varicella Zoster Virus (VZV) antibody
Description
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
Secondary Outcome Measure Information:
Title
Geometric mean titer of VZV antibody
Description
Change from baseline in geometric mean titer of VZV antibody at Day 42 as measured with gpELISA.
Time Frame
42 Days
Title
Serious Adverse Events
Description
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
Title
Presenting with Varicella or Herpes Zoster
Description
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
Other Pre-specified Outcome Measures:
Title
Psoriasis Area Severity Index (PASI)
Description
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
Title
Body Surface Area (BSA)
Description
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
Title
Physician Global Assessment (PGA)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyn Guenther, MD, FRCPC
Organizational Affiliation
The Guenther Dermatology Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inno-6041 study site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Inno-6041 study site
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada

12. IPD Sharing Statement

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

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