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

NCT02408159 | Terminated Phase 4

• 1 other identifier: Inno-6041
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

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.

Conditions

Psoriasis

Keywords

Live, attenuated virus varicella-zoster vaccine; Zostavax; herpes zoster; shingles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Geometric mean titer of VZV antibody

  42 Days

• Serious Adverse Events

  84 Days

• Presenting with Varicella or Herpes Zoster

  84 Days

Other Outcomes (3)

• Psoriasis Area Severity Index (PASI)

  84 Days

• Body Surface Area (BSA)

  84 Days

• Physician Global Assessment (PGA)

  84 Days

Study Arms (2)

Varicella Zoster Vaccine

EXPERIMENTAL

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

0.9% Sodium Chloride

PLACEBO COMPARATOR

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

Interventions

Varicella Zoster Vaccine DRUG

Also known as: Zostavax®

Varicella Zoster Vaccine

Placebo DRUG

Also known as: 0.9% Sodium Chloride, Saline 0.9%

0.9% Sodium Chloride

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Inno-6041 study site

London, Ontario, Canada

Location

Inno-6041 study site

Markham, Ontario, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Psoriasis; Herpes Zoster

Interventions

Herpes Zoster Vaccine; Sodium Chloride

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lyn Guenther, MD, FRCPC

  The Guenther Dermatology Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2016-08

Locations

CA (3)