Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE March 31, 2015
First Posted Date  ICMJE April 3, 2015
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE June 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02408159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 31, 2015)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Varicella Zoster Vaccine in Patients With Plaque Psoriasis Treated With Biologic Therapy
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Varicella Zoster Vaccine
    Other Name: Zostavax®
  • Drug: Placebo
    Other Names:
    • 0.9% Sodium Chloride
    • Saline 0.9%
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Varicella Zoster Vaccine
  • 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.

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 6, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2015)
50
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02408159
Other Study ID Numbers  ICMJE Inno-6041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Innovaderm Research Inc.
Study Sponsor  ICMJE Innovaderm Research Inc.
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Lyn Guenther, MD, FRCPC The Guenther Dermatology Research Center
PRS Account Innovaderm Research Inc.
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP