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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02408159
• Other study ID #: Inno-6041
• Status: Terminated
• Phase: Phase 4
• First received: March 31, 2015
• Last updated: June 29, 2017
• Start date: June 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2016
• Source: Innovaderm Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Psoriasis

Intervention

Drug:
• Varicella Zoster Vaccine

• Placebo

Locations

Country	Name	City	State
Canada	Inno-6041 study site	London	Ontario
Canada	Inno-6041 study site	Markham	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Innovaderm Research Inc.	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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