- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03685682
Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients
August 4, 2020 updated by: Deepali Kumar, University Health Network, Toronto
Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine in VZV-seronegative Solid Organ Transplant Recipients
The investigators plan to study the immunogenicity of the vaccine in VZV-seronegative solid organ transplant recipients.
VZV-seronegative patients will be enrolled after organ transplantation.
The investigators hypothesize that the recombinant subunit Herpes zoster vaccine is able to induce cellular immunogenicity after transplantation in VZV-seronegative patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for severe primary VZV infection (chickenpox) and VZV reactivation (shingles).
A non-live, recombinant subunit Herpes zoster vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older and was shown to induce both cellular and humoral immunity.
As both components of the immune system are important for protection against VZV, the investigators plan to study the humoral and cellular immunogenicity of the vaccine after organ transplantation in VZV-seronegative patients.
Indeed, the current live VZV vaccine is contraindicated after transplantation; therefore, the non-live recombinant varicella-zoster subunit vaccine, if shown to induce cellular and humoral immunity, could potentially be offered to VZV-seronegative transplant patients.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G2N2
- University Health Network, Toronto General Hospital, Multi-Organ Transplant
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Solid organ transplant recipient.
- Age ≥18 years
- VZV-seronegative at time of transplant
- ≥90 days post-transplant
- Able to provide informed consent
Exclusion Criteria:
- Has already received the recombinant subunit Herpes zoster vaccine in the past
- Ongoing CMV viremia > 200 IU/mL
- HIV infection
- Diagnosis of malignancy (e.g. PTLD)
- History of a severe allergic reaction (anaphylactic reaction) after any vaccine
- Documented Chickenpox or Shingles after transplantation
- Congenital immunodeficiency (e.g., CVID)
- Treatment for rejection in the past 30 days
- Immunoglobulin in the past 30 days or anticipated to receive immunoglobulin
- Anti-CD20 monoclonal antibody in the past 6 months or anticipated to receive Anti-CD20 monoclonal antibody
- Plasmapheresis in the past 30 days or anticipated to receive plasmapheresis
- Febrile illness in the past one week
- Unable to comply with the study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VZV seronegative Transplant Patients
recombinant subunit Herpes zoster vaccine
|
Seronegative Solid Organ Transplant patients will receive two doses of the subunit Herpes zoster vaccine at 0 and 2-6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine.
Time Frame: 4 weeks after second dose of vaccine
|
Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination
|
4 weeks after second dose of vaccine
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Vaccine-related Adverse Events
Time Frame: Up to 4 weeks after second dose of vaccine
|
Adverse events will be graded as mild, moderate, severe
|
Up to 4 weeks after second dose of vaccine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Deepali Kumar, MD, Multi organ transplant program, University Health Network, Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2018
Primary Completion (Actual)
September 5, 2019
Study Completion (Actual)
September 5, 2019
Study Registration Dates
First Submitted
September 23, 2018
First Submitted That Met QC Criteria
September 24, 2018
First Posted (Actual)
September 26, 2018
Study Record Updates
Last Update Posted (Actual)
August 5, 2020
Last Update Submitted That Met QC Criteria
August 4, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHNTID007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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