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Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients

Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients

Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

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

Study details
    Immunosuppression
    Vaccine Response Impaired

NCT06262776

Central Adelaide Local Health Network Incorporated

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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