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PsoriasisPhase 4NCT02408159

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

A Phase 4 study testing Varicella Zoster Vaccine in people with Psoriasis, run by Innovaderm Research Inc. at 3 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Psoriasis
What is being tested?
Varicella Zoster Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
3 sitesCanada
Study dates
Jun 2016to Mar 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Inno-6041 study site

    London, Ontario

  • Inno-6041 study site

    Markham, Ontario

  • Innovaderm Research Inc.

    Montreal, Quebec, H2K 4L5

Other trials in Canada

About this study

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

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.

Read more

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
Being tested
Varicella Zoster Vaccine, Placebo
Keywords
Live, attenuated virus varicella-zoster vaccine, Zostavax, herpes zoster, shingles
Medical subject headings
Psoriasis, Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Varicella Zoster VaccineDrug

    Also called Zostavax®

  • PlaceboDrug

    Also called 0.9% Sodium Chloride, Saline 0.9%

Study groups in NCT02408159
Study groupRoleWhat they receive
Varicella Zoster VaccineExperimentalSterile, 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.
Receives: Drug: Varicella Zoster Vaccine
0.9% Sodium ChloridePlacebo comparatorUnited States Pharmacopeia (USP), preservative free for injection supplied in a single dose vial. A single dose will be administered to subjects at baseline.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 42 Days

Secondary outcomes (3)

  1. Geometric mean titer of VZV antibody

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

    Measured: 42 Days

  2. 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.

    Measured: 84 Days

  3. 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

    Measured: 84 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2015 (estimated)
  2. Study startJun 2016
  3. Primary completionJan 2017
  4. Study completionMar 2017

Why it stopped: Recruitment difficulties

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02408159
Sponsor's protocol ID
Inno-6041
Status last verified
Aug 2016
First submitted
31 Mar 2015
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Varicella Zoster Vaccine in people with Psoriasis, run by Innovaderm Research Inc. at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Varicella Zoster Virus (VZV) antibody (time frame: 42 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02408159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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