ImmunosuppressionSIR ZOSTERNCT06262776
Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients
A study testing Recombinant zoster vaccine adjuvanted (SHINGRIX) in people with Immunosuppression and Vaccine Response Impaired, run by Central Adelaide Local Health Network Incorporated at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunosuppression, Vaccine Response Impaired
- What is being tested?
- Recombinant zoster vaccine adjuvanted (SHINGRIX)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Mar 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- Aged <50 years
- Unable or unwilling to provide informed consent to participate in the trial
- Known allergy to or intolerance of the contents of the RZV vaccine
- No previous infection with VZV (chickenpox)
- History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy
- Population - Groups 2-4. Transplant recipients (n = 90)
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- Aged <18 years
- Unable or unwilling to provide informed consent to participate in the trial
- No previous infection with VZV (chickenpox)
- Known allergy to or intolerance of the contents of the RZV vaccine
- Current pregnancy
- Population - Group 5. Other (n = 10)
- Aged <18 years
- Unable or unwilling to provide informed consent to participate in the trial
- Known allergy to or intolerance of the contents of the RZV vaccine
- No previous infection with VZV (chickenpox)
- Known allergy to or intolerance of the contents of the RZV vaccine
- Current pregnancy
- History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy
- Population - Group 6. Dialysis group (n = 30)
- Aged <18 years
- Unable or unwilling to provide informed consent to participate in the trial
- Known allergy to or intolerance of the contents of the RZV vaccine
- No previous infection with VZV (chickenpox)
- Known allergy to or intolerance of the contents of the RZV vaccine
- Current pregnancy
- History of primary immunodeficiency or active immunosuppressive therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Patrick T Coates, PhD FRACP, +6170740000, Toby.Coates@sa.gov.au
About this study
Official title: Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)
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:
- Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens?
- 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
- Immunosuppression, Vaccine Response Impaired
- Being tested
- Recombinant zoster vaccine adjuvanted (SHINGRIX)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant zoster vaccine adjuvanted (SHINGRIX)Biological
2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination group | Experimental | 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. Receives: Biological: Recombinant zoster vaccine adjuvanted (SHINGRIX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional T cell memory
ELISpot measurement of interferon gamma spot-forming units following 18-hour stimulation of peripheral blood mononuclear cells with Zoster gE protein-derived peptide array
Measured: 3 weeks following second vaccine dose
Secondary outcomes (6)
Frequency of virus specific T cells
Change in frequency of CD8+ Zoster gE protein-specific T cells identified by flow cytometry as CD8+CD134+CD69+ following 24-hour stimulation with a gE protein-derived peptide array
Measured: 3 weeks and 52 weeks following second vaccine dose
Magnitude of antibody response
Anti Varicella zoster gE Immunoglobulin M (IgM) and IgG antibody titres compared to baseline
Measured: 3 weeks and 52 weeks following second vaccine dose
Concentration of post-vaccination circulating cytokines
Post-vaccination circulating cytokines compared to baseline
Measured: 3 weeks following second vaccine dose
Frequency of polyfunctional T cells
Change in frequency of Zoster gE protein-specific polyfunctional T cells identified by flow cytometry intracellular cytokine staining (interferon-gamma, interleukin-2, tumour necrosis factor) following 24-hour stimulation with a gE protein-derived peptide array.
Measured: 3 weeks and 52 weeks following second vaccine dose
Magnitude of vaccine-induced cross-protective antiviral responses
T cells will be investigated for cross-protective herpesviridae responses using interferon gamma ELISpot compared to baseline following 24-hour stimulation with a gE protein-derived peptide array.
Measured: 3 weeks and 52 weeks following second vaccine dose
Frequency of virus-specific T stem cell memory compared to baseline
Frequency of Zoster gE protein-specific T stem cell memory (Tscm) will be determined by flow cytometry based on expression of T cell phenotypic markers (CD27+CD45RA+CD95+) on activation-induced marker-positive CD4 and CD8 T cells
Measured: 3 weeks and 52 weeks following second vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start20 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Adelaide Local Health Network Incorporated
- Sponsor type
- Other government
- Collaborators
- National Health and Medical Research Council, Australia, University of Adelaide, Royal Prince Alfred Hospital, Sydney, Australia
- Responsible party
- Principal investigator, Matthew Tunbridge, Central Adelaide Local Health Network Incorporated
- Investigators
- Patrick T Coates, FRACP, Principal investigator, Central and Northern Adelaide Renal and Transplantation Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262776
- Sponsor's protocol ID
- SIRZOSTER1.01
- Acronym
- SIR ZOSTER
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)
- ClinicalTrials.gov ID
- NCT06262776
- Acronym / sponsor ID
- SIR ZOSTER / SIRZOSTER1.01
- Conditions
- Immunosuppression, Vaccine Response Impaired
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Central Adelaide Local Health Network IncorporatedOther government
- Collaborators
- National Health and Medical Research Council, Australia, University of Adelaide, Royal Prince Alfred Hospital, Sydney, Australia
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination group | Experimental | Biological: Recombinant zoster vaccine adjuvanted (SHINGRIX)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- -- Specific immunosuppression regimen
- Kidney failure receiving haemodialysis as kidney replacement therapy
- Aged >18 years
- Previous documented infection with VZV (known infection history or positive VZV IgG result)
Key exclusion criteria (27 listed)
- Population - Groups 2-4. Transplant recipients (n = 90)
- Population - Group 5. Other (n = 10)
- Population - Group 6. Dialysis group (n = 30)
- Aged <18 years
- Unable or unwilling to provide informed consent to participate in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant zoster vaccine adjuvanted (SHINGRIX)2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8. | Biological | Vaccination group |
Primary outcome
Functional T cell memory
Time frame: 3 weeks following second vaccine dose
ELISpot measurement of interferon gamma spot-forming units following 18-hour stimulation of peripheral blood mononuclear cells with Zoster gE protein-derived peptide array
6 secondary outcomes
Frequency of virus specific T cells
Time frame: 3 weeks and 52 weeks following second vaccine dose
Magnitude of antibody response
Time frame: 3 weeks and 52 weeks following second vaccine dose
Concentration of post-vaccination circulating cytokines
Time frame: 3 weeks following second vaccine dose
Frequency of polyfunctional T cells
Time frame: 3 weeks and 52 weeks following second vaccine dose
Magnitude of vaccine-induced cross-protective antiviral responses
Time frame: 3 weeks and 52 weeks following second vaccine dose
Frequency of virus-specific T stem cell memory compared to baseline
Time frame: 3 weeks and 52 weeks following second vaccine dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick T Coates, FRACP principal investigator
Central and Northern Adelaide Renal and Transplantation Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant zoster vaccine adjuvanted (SHINGRIX) in people with Immunosuppression and Vaccine Response Impaired, run by Central Adelaide Local Health Network Incorporated at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick T Coates, MBBS, FRACP, PhD (70740000, Toby.Coates@sa.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional T cell memory (time frame: 3 weeks following second vaccine dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.