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Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation

Primary Purpose

Varicella Zoster Vaccine

Status

Unknown status

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

VZV subunit vaccine

About this trial

This is an interventional prevention trial for Varicella Zoster Vaccine

Eligibility Criteria

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

Inclusion Criteria Post-Transplant Vaccine Group:

Single or double lung transplant recipient.
Age ≥50 years

Exclusion Criteria Post-Transplant Vaccine Group:

Has already received varicella zoster subunit vaccine in the past
Shingles within the last 12 months
Ongoing CMV viremia > 200 IU/mL
HIV infection
Diagnosis of malignancy (eg PTLD)

Inclusion Criteria Pre-Transplant Vaccine Group:

On waiting list for lung transplantation
Age ≥50 years

Exclusion Criteria Pre-Transplant Vaccine Group:

Has already received Shingrix or Zostavax (live shingles vaccine) in the past
Systemic prednisone ≥20 mg per day (or equivalent dose of any corticosteroid)
Other (than prednisone < 20mg per day or equivalent dose of any corticosteroid) systemic immunosuppressive therapy such as mycophenolate or tacrolimus
Shingles within the last 12 months
HIV infection

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pre-Transplant Group

Post-Transplant Group

Arm Description

VZV Subunit vaccine will be administered

Outcomes

Primary Outcome Measures

Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine.

Cellular immunogenicity against VZV induced by varicella zoster subunit vaccine in lung transplant recipients measured as a percentage of CD4+ and CD8+ T-cells measured by intracellular flow-cytometry based staining. The cellular immunogenicity of the vaccine in lung transplant recipients will be compared to the control group (pre-transplant vaccination).

Secondary Outcome Measures

Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients.

Humoral immunogenicity (increase of GMTs of anti-VZV antibodies) in lung transplant

Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group

Humoral immunogenicity (GMTs of anti-VZV antibodies compared pre and post vaccination) against VZV induced by varicella zoster subunit vaccine in lung transplant recipients compared to the pre-transplant control group.

Full Information

NCT ID

NCT03493776

First Posted

March 29, 2018

Last Updated

October 16, 2020

Sponsor

Deepali Kumar

1. Study Identification

Unique Protocol Identification Number

NCT03493776

Brief Title

Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation

Official Title

Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 15, 2018 (Actual)

Primary Completion Date

September 5, 2019 (Actual)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Deepali Kumar

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.

Detailed Description

Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for reactivation of all herpesviruses including VZV. Epidemiologic studies show the cumulative incidence in lung transplant recipients of reactivation to be 15-20%. A non-live, recombinant subunit vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older. The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.

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 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pre-Transplant Group

Arm Type

Active Comparator

Arm Description

VZV Subunit vaccine will be administered

Arm Title

Post-Transplant Group

Arm Type

Experimental

Arm Description

VZV Subunit vaccine will be administered

Intervention Type

Biological

Intervention Name(s)

VZV subunit vaccine

Intervention Description

VZV subunit vaccine

Primary Outcome Measure Information:

Title

Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine.

Description

Time Frame

4 weeks after second dose of vaccine

Secondary Outcome Measure Information:

Title

Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients.

Description

Humoral immunogenicity (increase of GMTs of anti-VZV antibodies) in lung transplant

Time Frame

4 weeks after second dose of vaccine

Title

Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group

Description

Time Frame

4 weeks after second dose of vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Post-Transplant Vaccine Group: Single or double lung transplant recipient. Age ≥50 years Exclusion Criteria Post-Transplant Vaccine Group: Has already received varicella zoster subunit vaccine in the past Shingles within the last 12 months Ongoing CMV viremia > 200 IU/mL HIV infection Diagnosis of malignancy (eg PTLD) Inclusion Criteria Pre-Transplant Vaccine Group: On waiting list for lung transplantation Age ≥50 years Exclusion Criteria Pre-Transplant Vaccine Group: Has already received Shingrix or Zostavax (live shingles vaccine) in the past Systemic prednisone ≥20 mg per day (or equivalent dose of any corticosteroid) Other (than prednisone < 20mg per day or equivalent dose of any corticosteroid) systemic immunosuppressive therapy such as mycophenolate or tacrolimus Shingles within the last 12 months HIV infection

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

Learn more about this trial

Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation

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