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Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Household co-habitant of transplant recipient in trial

⁃ Aged \>50 years

⁃ Previous documented infection with VZV (known infection history or positive VZV IgG result)

⁃ 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)

⁃ Immunosuppressed patient receiving single-agent rapamycin immunosuppression

⁃ Aged \>18 years

⁃ Previous documented infection with VZV (known infection history or positive VZV IgG result)

• Kidney failure receiving haemodialysis as kidney replacement therapy

• Aged \>18 years

• Previous documented infection with VZV (known infection history or positive VZV IgG result)

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Contact Information
Primary
Patrick T Coates, MBBS, FRACP, PhD
Toby.Coates@sa.gov.au
70740000
Backup
Griffith B Perkins, PhD
Griffith.Perkins@adelaide.edu.au
70740000
Time Frame
Start Date: 2024-03-20
Estimated Completion Date: 2027-12
Participants
Target number of participants: 160
Treatments
Experimental: Vaccination group
All participants will receive the assigned intervention, a 2-dose course of Zoster recombinant adjuvanted vaccine. Study participants will include kidney transplant recipients receiving specific immunosuppressive medications, and non-immunosuppressed household cohabitants, with comparisons made in magnitude of vaccine response.
Related Therapeutic Areas
Sponsors
Collaborators: Royal Prince Alfred Hospital, Sydney, Australia, University of Adelaide, National Health and Medical Research Council, Australia
Leads: Central Adelaide Local Health Network Incorporated

This content was sourced from clinicaltrials.gov