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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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Innovaderm Research Inc.

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.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: Varicella Zoster Vaccine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


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 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.

Drug: Placebo
Other Names:
  • 0.9% Sodium Chloride
  • Saline 0.9%




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Inno-6041 study site
London, Ontario, Canada
Inno-6041 study site
Markham, Ontario, Canada
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Innovaderm Research Inc.
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Lyn Guenther, MD, FRCPC The Guenther Dermatology Research Center

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Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT02408159     History of Changes
Other Study ID Numbers: Inno-6041
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: August 2016
Keywords provided by Innovaderm Research Inc.:
Live, attenuated virus varicella-zoster vaccine
Zostavax
herpes zoster
shingles
Additional relevant MeSH terms:
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Psoriasis
Herpes Zoster
Chickenpox
Skin Diseases, Papulosquamous
Skin Diseases
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs