Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients
Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients (SIR ZOSTER)
Central Adelaide Local Health Network Incorporated
120 participants
Mar 20, 2024
INTERVENTIONAL
Conditions
Summary
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 Criteria11
- Single organ kidney transplant recipient, currently receiving a specific immunosuppression regimen:
- Calcineurin inhibitor (tacrolimus or cyclosporine), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30)
- Calcineurin inhibitor (tacrolimus or cyclosporine), mTOR inhibitor (sirolimus or everolimus), and oral steroid (n = 30)
- 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 Criteria5
- 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
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Interventions
2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06262776