Sponsor: Central Adelaide Local Health Network Incorporated
trial.available_in:
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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.
Who can participate
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