Actively Recruiting
Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients
Led by Central Adelaide Local Health Network Incorporated · Updated on 2026-04-09
160
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
C
Central Adelaide Local Health Network Incorporated
Lead Sponsor
N
National Health and Medical Research Council, Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy household co-habitant of a transplant recipient in the trial
- Aged over 50 years (for healthy co-habitants)
- Previous documented infection with Varicella Zoster Virus (known infection history or positive VZV IgG result)
- Organ transplant recipient on specified immunosuppression regimens (Tacrolimus, mycophenolate, prednisolone; Tacrolimus, mTORi, prednisolone; or mTORi, mycophenolate, prednisolone)
- Aged over 18 years (for transplant recipients and other groups)
- Estimated glomerular filtration rate (GFR) greater than 15 mL/min/1.73m2 (for transplant recipients)
- Immunosuppressed patient receiving single-agent rapamycin immunosuppression
- Kidney failure patient receiving haemodialysis as kidney replacement therapy
You will not qualify if you...
- Age under 50 years (for healthy co-habitants)
- Age under 18 years (for transplant recipients and other groups)
- Unable or unwilling to provide informed consent
- Known allergy or intolerance to the contents of the recombinant zoster vaccine
- No previous infection with Varicella Zoster Virus (chickenpox)
- History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy (except specified regimens for transplant recipients)
- Current pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
P
Patrick T Coates, MBBS, FRACP, PhD
CONTACT
G
Griffith B Perkins, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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