Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients

Central Adelaide Local Health Network Incorporated120 enrolled

Overview

The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are: 1. Are there differences in vaccination immunological responses in kidney transplant patients on different immunosuppression regimens? 2. Are there differences in vaccination immunological responses between kidney transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Immunosuppression Vaccine Response Impaired

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Single organ kidney transplant recipient, currently receiving a specific immunosuppression regimen: 1. Calcineurin inhibitor (tacrolimus or cyclosporine), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30) 2. Calcineurin inhibitor (tacrolimus or cyclosporine), mTOR inhibitor (sirolimus or everolimus), and oral steroid (n = 30) 3. mTOR inhibitor (sirolimus or everolimus), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30) * Aged \>18 years * estimated glomerular filtration rate (GFR) \> 15 mL/min/1.73m2 * Previous documented infection with Varicella zoster (known infection history or positive Varicella zoster IgG result) OR * Healthy household cohabitant of kidney transplant recipient enrolled in trial (n = 30) * Aged \> 50 years * Previous documented infection with Varicella zoster (known infection history or positive Varicella zoster IgG result) Exclusion Criteria: * Unable or unwilling to provide informed consent to participate in the trial * No previous infection with Varicella zoster (chickenpox) * Known allergy to or intolerance of the contents of the SHINGRIX vaccine * Current pregnancy * For healthy household cohabitants, history of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy

Outcomes

Primary Outcomes

Functional T cell memory

ELISpot measurement of interferon gamma spot-forming units following 18-hour stimulation of peripheral blood mononuclear cells with Zoster gE protein-derived peptide array

Time frame: 3 weeks following second vaccine dose

Secondary Outcomes

Frequency of virus specific T cells

Change in frequency of CD8+ Zoster gE protein-specific T cells identified by flow cytometry as CD8+CD134+CD69+ following 24-hour stimulation with a gE protein-derived peptide array