Actively Recruiting
Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)
Led by Central Adelaide Local Health Network Incorporated · Updated on 2026-04-09
160
Participants Needed
1
Research Sites
52 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
Researchers are studying how transplant patients respond to the Varicella Zoster vaccination compared to their healthy household members. The trial aims to understand whether different immunosuppressive medication regimens affect vaccine immune responses and how transplant recipients' responses differ from those of non-immunosuppressed cohabitants. Participants include kidney transplant recipients and healthy cohabitants, all receiving the vaccine to compare their immune system reactions. All participants receive two doses of the SHINGRIX recombinant Zoster vaccine, given as 0.5mL intramuscular injections at the start and eight weeks later. The study groups include transplant recipients on various immunosuppressive drug combinations and their healthy household members. Researchers will monitor immune responses at five timepoints from one week up to one year after vaccination to assess T cell memory and antibody levels. Participants will undergo immunological testing to measure their vaccine response, including T cell activity and antibody concentrations. These assessments occur at multiple intervals, focusing on immune cell frequency and cytokine levels. The study lasts for one year following vaccination, with careful monitoring of immune function to compare how well the vaccine works across different participant groups.
CONDITIONS
Brief Title
Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Household co-habitant of transplant recipient in trial and aged over 50 years with prior documented VZV infection (history or positive IgG)
- Organ transplant recipients aged over 18 years on specific immunosuppression regimens (tacrolimus, mycophenolate, prednisolone or mTOR inhibitors) with prior documented VZV infection
- Immunosuppressed patients receiving single-agent rapamycin, aged over 18 years with prior documented VZV infection
- Kidney failure patients on haemodialysis aged over 18 years with prior documented VZV infection
You will not qualify if you...
- Age under 50 years for healthy co-habitants or under 18 years for transplant recipients and other groups
- Unable or unwilling to provide informed consent
- Known allergy or intolerance to the recombinant zoster vaccine
- No previous infection with VZV (chickenpox)
- History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy (except specified regimens)
- Current pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive 2 doses of recombinant zoster vaccine adjuvanted via intramuscular injection at week 0 and week 8.
2 vaccination visits (in-person)
Duration - Up to 52 weeks following second vaccine dose
Participants are monitored for immune response and safety for up to 52 weeks following the second vaccine dose.
Visits at 3 weeks and 52 weeks after second dose
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
G
Griffith B Perkins, PhD
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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