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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06262776




Registration number
NCT06262776
Ethics application status
Date submitted
31/01/2024
Date registered
16/02/2024

Titles & IDs
Public title
Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients
Scientific title
Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients (SIR ZOSTER)
Secondary ID [1] 0 0
SIRZOSTER1.01
Universal Trial Number (UTN)
Trial acronym
SIR ZOSTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunosuppression 0 0
Vaccine Response Impaired 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Recombinant zoster vaccine adjuvanted (SHINGRIX)

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.


Treatment: Other: Recombinant zoster vaccine adjuvanted (SHINGRIX)
2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Functional T cell memory
Timepoint [1] 0 0
3 weeks following second vaccine dose
Secondary outcome [1] 0 0
Frequency of virus specific T cells
Timepoint [1] 0 0
3 weeks and 52 weeks following second vaccine dose
Secondary outcome [2] 0 0
Magnitude of antibody response
Timepoint [2] 0 0
3 weeks and 52 weeks following second vaccine dose
Secondary outcome [3] 0 0
Concentration of post-vaccination circulating cytokines
Timepoint [3] 0 0
3 weeks following second vaccine dose
Secondary outcome [4] 0 0
Frequency of polyfunctional T cells
Timepoint [4] 0 0
3 weeks and 52 weeks following second vaccine dose
Secondary outcome [5] 0 0
Magnitude of vaccine-induced cross-protective antiviral responses
Timepoint [5] 0 0
3 weeks and 52 weeks following second vaccine dose
Secondary outcome [6] 0 0
Frequency of virus-specific T stem cell memory compared to baseline
Timepoint [6] 0 0
3 weeks and 52 weeks following second vaccine dose

Eligibility
Key inclusion criteria
* Single organ kidney transplant recipient, currently receiving a specific immunosuppression regimen:

1. Calcineurin inhibitor (tacrolimus or cyclosporine), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30)
2. Calcineurin inhibitor (tacrolimus or cyclosporine), mTOR inhibitor (sirolimus or everolimus), and oral steroid (n = 30)
3. 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network Incorporated
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Adelaide
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick T Coates, FRACP
Address 0 0
Central and Northern Adelaide Renal and Transplantation Services
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Matthew J Tunbridge, FRACP
Address 0 0
Country 0 0
Phone 0 0
70740000
Fax 0 0
Email 0 0
Matthew.Tunbridge@sa.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Identifiable data will not be publicly released, however, de-identified data will be made available in combination with publication of study results either as supplementary material or on public repository. Study protocol and statistical analysis plan will be made available as supplementary material with publication of results.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will be made available following publication of trial results, and will be available in perpetuity.
Available to whom?
Trial results and supporting information outlined above will be made available through open access publishing.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06262776