Comparing vaccine responses in kidney transplant patients and their healthy cohabitants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the immunological responses to the Varicella Zoster vaccination in kidney transplant recipients who are on different immunosuppression regimens, as well as in their healthy cohabitants. Participants will receive a two-dose course of the SHINGRIX recombinant Zoster vaccine, with immunological responses measured at five time points from one week to one year post-vaccination. The study seeks to determine if there are significant differences in vaccine responses based on the type of immunosuppression and between transplant patients and healthy individuals.

Why it matters

Who can join: the full rules

1. Population - Group 1. Healthy co-habitants (n = 30)

   Inclusion criteria:
   * Household co-habitant of transplant recipient in trial
   * Aged \>50 years
   * Previous documented infection with VZV (known infection history or positive VZV IgG result)

   Exclusion criteria:
   * Aged \<50 years
   * Unable or unwilling to provide informed consent to participate in the trial
   * Known allergy to or intolerance of the contents of the RZV vaccine
   * No previous infection with VZV (chickenpox)
   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy
2. Population - Groups 2-4. Transplant recipients (n = 90)

   Inclusion criteria:
   * Organ transplant recipients

     \-- Specific immunosuppression regimen
     * Tacrolimus, mycophenolate, prednisolone (n = 30, Group 2)
     * Tacrolimus, mTORi, prednisolone (n = 30, Group 3)
     * mTORi, mycophenolate, prednisolone (n = 30, Group 4)
   * Aged \>18 years
   * estimated GFR \> 15 mL/min/1.73m2
   * Previous documented infection with VZV (known infection history or positive VZV IgG result)

   Exclusion criteria:
   * Aged \<18 years
   * Unable or unwilling to provide informed consent to participate in the trial
   * No previous infection with VZV (chickenpox)
   * Known allergy to or intolerance of the contents of the RZV vaccine
   * Current pregnancy
3. Population - Group 5. Other (n = 10)

   Inclusion criteria:
   * Immunosuppressed patient receiving single-agent rapamycin immunosuppression
   * Aged \>18 years
   * Previous documented infection with VZV (known infection history or positive VZV IgG result)

   Exclusion criteria:
   * Aged \<18 years
   * Unable or unwilling to provide informed consent to participate in the trial
   * Known allergy to or intolerance of the contents of the RZV vaccine
   * No previous infection with VZV (chickenpox)
   * Known allergy to or intolerance of the contents of the RZV vaccine
   * Current pregnancy
   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy
4. Population - Group 6. Dialysis group (n = 30)

Inclusion criteria:

* Kidney failure receiving haemodialysis as kidney replacement therapy
* Aged \>18 years
* Previous documented infection with VZV (known infection history or positive VZV IgG result)

Exclusion criteria:

* Aged \<18 years
* Unable or unwilling to provide informed consent to participate in the trial
* Known allergy to or intolerance of the contents of the RZV vaccine
* No previous infection with VZV (chickenpox)
* Known allergy to or intolerance of the contents of the RZV vaccine
* Current pregnancy
* History of primary immunodeficiency or active immunosuppressive therapy

Where it's running

• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Recruiting

Study contacts

• Principal investigator: Patrick T Coates, FRACP — Central and Northern Adelaide Renal and Transplantation Services
• Study coordinator: Patrick T Coates, MBBS, FRACP, PhD
• Email: Toby.Coates@sa.gov.au
• Phone: 70740000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.