Overview

The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between 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 transplant patients on different immunosuppression regimens?
2. Are there differences in vaccination immunological responses between 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

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