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Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients

Primary Purpose

Varicella Zoster Vaccine

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
recombinant subunit Herpes zoster vaccine
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella Zoster Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network, Toronto General Hospital, Multi-Organ Transplant

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VZV seronegative Transplant Patients

Arm Description

recombinant subunit Herpes zoster vaccine

Outcomes

Primary Outcome Measures

Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine.
Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination

Secondary Outcome Measures

Rate of Vaccine-related Adverse Events
Adverse events will be graded as mild, moderate, severe

Full Information

First Posted
September 23, 2018
Last Updated
August 4, 2020
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03685682
Brief Title
Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients
Official Title
Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine in VZV-seronegative Solid Organ Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 25, 2018 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella Zoster Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VZV seronegative Transplant Patients
Arm Type
Experimental
Arm Description
recombinant subunit Herpes zoster vaccine
Intervention Type
Biological
Intervention Name(s)
recombinant subunit Herpes zoster vaccine
Intervention Description
Seronegative Solid Organ Transplant patients will receive two doses of the subunit Herpes zoster vaccine at 0 and 2-6 months
Primary Outcome Measure Information:
Title
Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine.
Description
Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination
Time Frame
4 weeks after second dose of vaccine
Secondary Outcome Measure Information:
Title
Rate of Vaccine-related Adverse Events
Description
Adverse events will be graded as mild, moderate, severe
Time Frame
Up to 4 weeks after second dose of vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepali Kumar, MD
Organizational Affiliation
Multi organ transplant program, University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Toronto General Hospital, Multi-Organ Transplant
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2N2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33528118
Citation
L'Huillier AG, Hirzel C, Ferreira VH, Ierullo M, Ku T, Selzner N, Schiff J, Juvet S, Miao C, Schmid DS, Humar A, Kumar D. Evaluation of Recombinant Herpes Zoster Vaccine for Primary Immunization of Varicella-seronegative Transplant Recipients. Transplantation. 2021 Oct 1;105(10):2316-2323. doi: 10.1097/TP.0000000000003621.
Results Reference
derived

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Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients

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