Vaccine Immune ResponsePhase 2VON TRAPPNCT07587801
Vaccination Response Modulation With a Targeted Rapamycin Protocol Study
A Phase 2 study testing Sirolimus (RAPAMUNE), Influenza vaccine (Sequiris Fluad Quad) and RSV vaccine (Pfizer Abrysvo) in people with Vaccine Immune Response and Haemodialysis Patients, run by Central Adelaide Local Health Network Incorporated at 3 sites in Australia.
Trial summary
This study will investigate dialysis recipients' responses to important vaccines. Research suggests that a medication commonly used by transplant recipients may improve vaccine responses. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Vaccine Immune Response, Haemodialysis Patients, Older Adults
- What is being tested?
- Sirolimus (RAPAMUNE), Influenza vaccine (Sequiris Fluad Quad) and RSV vaccine (Pfizer Abrysvo)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesAustralia
- Study dates
- May 2026to Jul 2026
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage kidney disease requiring in-centre haemodialysis three times per week as kidney replacement therapy
- Aged >60 years
Who cannot join
- Aged <60 years
- Alternative haemodialysis regimens (e.g. twice-weekly haemodialysis, second-daily home haemodialysis)
- Recent infection (<6 months) with proven Influenza A, Influenza B, or RSV
- Current use of immunosuppressive medications, including:
- Oral steroid at a dose equivalent of 5 mg/day prednisolone or greater
- Mycophenolate mofetil
Show all 28Show fewer
- Azathioprine
- Calcineurin inhibitors
- mTOR inhibitors
- Recent use of intravenous immunosuppressive medications (<6 months), including:
- T-cell depleting agents (e.g. anti-thymocyte globulin)
- B-cell depleting agents (e.g. rituximab)
- Cyclophosphamide
- Has a history of problems with side-effects associated with sirolimus use including
- Angioedema
- Active/recent opportunistic infection
- Current or prior interstitial lung disease, non-infectious pneumonitis, organising pneumonia, or pulmonary fibrosis
- Clinically significant pleural effusion or pericardial effusion
- Active non-healing wounds, chronic skin ulcers, or planned major surgery/procedures
- Current malignancy or recent malignancy with high recurrence risk
- Severe or uncontrolled hyperlipidaemia
- History of rhabdomyolysis
- Severe hepatic impairment
- Ongoing use of strong CYP3A4/P-gp inhibitors or inducers including
- Inhibitors: Ketoconazole, Voriconazole, Itraconazole, Telithromycin, Clarithromycin
- Inducers: Rifampicin, Rifabutin
- Unable or unwilling to provide informed consent to participate in the trial
- Known allergy to or intolerance of sirolimus (rapamycin) or the contents of the influenza or RSV vaccine
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Griffith Perkins, BSc PhD contact
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Toby Coates, MBBS PhD FRACP, (08) 7074 0000, Toby.Coates@sa.gov.au
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Steve Chadban, MBBS PhD FRACP, (02) 9515 6111, Steve.Chadban@health.nsw.gov.au
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Matthew Tunbridge, MBBS FRACP, (07) 3176 2111, Matthew.Tunbridge@health.qld.gov.au
About this study
Official title: Vaccination Response Modulation With a Targeted Rapamycin Protocol (VON TRAPP) Study
This study will investigate dialysis recipients' responses to important vaccines.
Research suggests that a medication commonly used by transplant recipients may improve vaccine responses. The investigators will be conducting a clinical trial to see whether a short course of low-dose Sirolimus improves the response to vaccination against respiratory syncytial virus (RSV) and influenza (flu) in patient with kidney disease over 60 years old who receive haemodialysis.
Read the detailed description
Respiratory viruses are a significant cause of morbidity and mortality in Australia. Respiratory syncytial virus (RSV) and Influenza are major contributors to yearly respiratory virus epidemics that particularly affect older persons and persons with end-stage kidney disease.
Vaccination is available for the prevention of both RSV and Influenza, but unfortunately the conditions that confer a higher risk of morbidity and mortality with infection are also key predictors of poor responses to vaccination.
Effective vaccine responses require activation of both T and B cells to generate protective and long-lasting antibody and cellular immune responses. Immunosenescence from ageing and end-stage kidney disease, dampens antibody responses and impairs cellular immunity, rendering patients vulnerable to infection.
Previous research suggests that sirolimus(rapamycin)-based immunosuppression regimens improve vaccine immunogenicity. Sirolimus (rapamycin) is a potent inhibitor of mTORC1 which regulates memory CD8+ T cells. Targeting mTORC1 has previous been shown to improve vaccination response in humans to influenza. More recently, small studies have suggested improved responses to COVID vaccination in kidney transplant recipients switched to sirolimus (rapamycin)-based regimens.
This study will investigate a role for sirolimus (rapamycin) as a peri-vaccination immune modulation therapy. The VON TRAPP study is a phase 2a randomised clinical trial that aims to define the optimal, practical and tolerable regimen of peri-vaccination sirolimus (rapamycin) administration to positively modify vaccine responses. Haemodialysis patients over 60 years old will receive both Influenza and RSV vaccines plus either no additional treatment or a peri-vaccination regimen of sirolimus (rapamycin) to determine the most effective regimen to test further.
- Being tested
- Sirolimus (RAPAMUNE), Influenza vaccine (Sequiris Fluad Quad), RSV vaccine (Pfizer Abrysvo)
- Keywords
- influenza, RSV, vaccine, haemodialysis, older adults, immunosenescence
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus (RAPAMUNE)Drug
Also called Rapamycin
All treatment groups will receive 9 doses of 2mg sirolimus over a 3 week period, at varying times relative to vaccination.
Influenza vaccine (Sequiris Fluad Quad)Biological
All participants will receive a dose of the seasonal Influenza vaccine (Sequiris Fluad Quad)
RSV vaccine (Pfizer Abrysvo)Biological
All participants will receive a dose of the RSV vaccine (Pfizer Abrysvo)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Influenza and RSV vaccination without additional treatment Receives: Biological: Influenza vaccine (Sequiris Fluad Quad); Biological: RSV vaccine (Pfizer Abrysvo) |
| Pre-vaccine sirolimus group | Experimental | Sirolimus 2mg orally x3/week on haemodialysis for 3 weeks. Influenza and RSV vaccination 2 weeks after completing sirolimus course. Receives: Drug: Sirolimus (RAPAMUNE); Biological: Influenza vaccine (Sequiris Fluad Quad); Biological: RSV vaccine (Pfizer Abrysvo) |
| Peri-vaccine sirolimus group | Experimental | Sirolimus 2mg orally x3/week on haemodialysis for 3 weeks. Influenza and RSV vaccination 1 week after commencing sirolimus course. Receives: Drug: Sirolimus (RAPAMUNE); Biological: Influenza vaccine (Sequiris Fluad Quad); Biological: RSV vaccine (Pfizer Abrysvo) |
| Post-vaccine sirolimus group | Experimental | Sirolimus 2mg orally x3/week on haemodialysis for 3 weeks. Influenza and RSV vaccination 2 weeks prior to commencing sirolimus course. Receives: Drug: Sirolimus (RAPAMUNE); Biological: Influenza vaccine (Sequiris Fluad Quad); Biological: RSV vaccine (Pfizer Abrysvo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine-specific functional T cell memory
The change in functional T cell memory from baseline to six weeks post vaccine dose, measured as IFN-γ spot-forming units (SFU) by ELISpot following 18-hour stimulation of PBMCs with RSV peptides.
Measured: Six weeks post vaccination
Secondary outcomes (20)
Cellular immune response to vaccination
RSV vaccine-specific cellular immunity, measured as 1) change in frequency of CD8+ RSV F protein-specific T cells from baseline to six weeks post vaccine dose, identified by flow cytometry as CD8+CD134+CD69+ following 24-hour stimulation with a protein-derived peptide array (AIM, Activation-Induced Marker assay); 2) Change in frequency of RSV F protein-specific polyfunctional T cells from baseline to six weeks post vaccine dose. Polyfunctional T cells are defined as CD4+ T cells that produce more than one of IFN-γ, IL-2 and TNF identified by flow cytometry intracellular cytokine staining following 24-hour stimulation with a protein-derived peptide array (ICS, Intracellular Cytokine Staining assay).
Measured: Six weeks post vaccination
Vaccine-specific humoral immune response
Measures of vaccine-specific humoral immunity, measured as 1) Anti-RSV F protein IgM, IgA and IgG antibody titres 6 weeks following the vaccine dose; 2) Change in haemagglutination inhibition (HAI) titre of influenza strains contained in the 2026 vaccine from baseline to six weeks post vaccination.
Measured: Six week post vaccination
Incidence of infection post-vaccination
Incidence of RSV or Influenza infection in the study cohort from 3 weeks post vaccination to 12-month follow-up
Measured: Twelve months post vaccination
Incidence of Sirolimus (Rapamycin) Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and tolerability of 3-week course of low-dose sirolimus (rapamycin), measured as frequency of adverse events (including serious adverse events)
Measured: Six week post vaccination
Incidence of Immunization Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and tolerability of vaccine regimen, assessed by 1. Frequency of adverse events following immunization (AEFI), including adverse events of special interest (AESI) such as recurrence of autoimmune disease
Measured: Six weeks post vaccination
Quality of life questionnaire
Quality of life following 3-week course of low-dose sirolimus (rapamycin) and vaccination, measured with the EQ-5D-5L quality of life questionnaire. This questionnaire reports on 5 functional domains using an ordinal scale from 1 (worst) to 5 (best) to provide a combined health state score.
Measured: Six weeks post-vaccination
Circulating IL-1β analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factor IL-1β from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IFN-α2 analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factor IFN-α2 from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IFN-γ analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factors IFN-γ from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating TNF-α analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factors TNF-α from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating MCP-1 analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factors MCP-1 from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-6 analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factor IL-6 from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating CXCL8 (IL-8)
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factor CXCL8 (IL-8) from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-10 analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factor IL-10 from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-12p70 analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factor IL-12p70 from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-17A analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factors IL-17A from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-18 analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factors IL-18 from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-23 analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factors IL-23 from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-33 analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factors IL-33 from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating CRP analysis
Pre- and post-sirolimus circulating cytokine and chemokine analysis, measured as change in concentration of serum factors CRP from baseline to the end of sirolimus administration.
Measured: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study startMay 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Immune ResponseStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised to three sirolimus treatment groups and a control group (1:1:1:1). All participants will receive an RSV and seasonal influenza vaccine at week 0. All treatment groups will receive 9 doses of 2mg sirolimus over a 3 week period, at varying times relative to vaccination. The "pre-vaccine" group will receive sirolimus beginning 5 weeks before vaccination and ceasing 2 weeks before vaccination. The "peri-vaccine" group will receive sirolimus beginning 1 week prior to vaccination and ceasing 2 weeks post vaccination. The "post-vaccine" group will receive sirolimus beginning 2 weeks post vaccination and ceasing 5 weeks post vaccination.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Adelaide Local Health Network Incorporated
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Matthew Tunbridge, Central Adelaide Local Health Network Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587801
- Sponsor's protocol ID
- 2025/HRE00483
- Acronym
- VON TRAPP
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized patient-level data created for the study will be available in a persistent repository upon publication. Data will be uploaded to figshare.com.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Response Modulation With a Targeted Rapamycin Protocol (VON TRAPP) Study
- ClinicalTrials.gov ID
- NCT07587801
- Acronym / sponsor ID
- VON TRAPP / 2025/HRE00483
- Keywords
- influenza, RSV, vaccine, haemodialysis, older adults, immunosenescence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Adelaide Local Health Network IncorporatedOther government
- Study start
- May 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 14 May 2026 (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.
This study will investigate dialysis recipients' responses to important vaccines.
Research suggests that a medication commonly used by transplant recipients may improve vaccine responses. The investigators will be conducting a clinical trial to see whether a short course of low-dose Sirolimus improves the response to vaccination against respiratory syncytial virus (RSV) and influenza (flu) in patient with kidney disease over 60 years old who receive haemodialysis.
Detailed description
Respiratory viruses are a significant cause of morbidity and mortality in Australia. Respiratory syncytial virus (RSV) and Influenza are major contributors to yearly respiratory virus epidemics that particularly affect older persons and persons with end-stage kidney disease.
Vaccination is available for the prevention of both RSV and Influenza, but unfortunately the conditions that confer a higher risk of morbidity and mortality with infection are also key predictors of poor responses to vaccination.
Effective vaccine responses require activation of both T and B cells to generate protective and long-lasting antibody and cellular immune responses. Immunosenescence from ageing and end-stage kidney disease, dampens antibody responses and impairs cellular immunity, rendering patients vulnerable to infection.
Previous research suggests that sirolimus(rapamycin)-based immunosuppression regimens improve vaccine immunogenicity. Sirolimus (rapamycin) is a potent inhibitor of mTORC1 which regulates memory CD8+ T cells. Targeting mTORC1 has previous been shown to improve vaccination response in humans to influenza. More recently, small studies have suggested improved responses to COVID vaccination in kidney transplant recipients switched to sirolimus (rapamycin)-based regimens.
This study will investigate a role for sirolimus (rapamycin) as a peri-vaccination immune modulation therapy. The VON TRAPP study is a phase 2a randomised clinical trial that aims to define the optimal, practical and tolerable regimen of peri-vaccination sirolimus (rapamycin) administration to positively modify vaccine responses. Haemodialysis patients over 60 years old will receive both Influenza and RSV vaccines plus either no additional treatment or a peri-vaccination regimen of sirolimus (rapamycin) to determine the most effective regimen to test further.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomised to three sirolimus treatment groups and a control group (1:1:1:1). All participants will receive an RSV and seasonal influenza vaccine at week 0. All treatment groups will receive 9 doses of 2mg sirolimus over a 3 week period, at varying times relative to vaccination. The "pre-vaccine" group will receive sirolimus beginning 5 weeks before vaccination and ceasing 2 weeks before vaccination. The "peri-vaccine" group will receive sirolimus beginning 1 week prior to vaccination and ceasing 2 weeks post vaccination. The "post-vaccine" group will receive sirolimus beginning 2 weeks post vaccination and ceasing 5 weeks post vaccination.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Biological: Influenza vaccine (Sequiris Fluad Quad), Biological: RSV vaccine (Pfizer Abrysvo)Influenza and RSV vaccination without additional treatment |
| Pre-vaccine sirolimus group | Experimental | Drug: Sirolimus (RAPAMUNE), Biological: Influenza vaccine (Sequiris Fluad Quad), Biological: RSV vaccine (Pfizer Abrysvo)Sirolimus 2mg orally x3/week on haemodialysis for 3 weeks. Influenza and RSV vaccination 2 weeks after completing sirolimus course. |
| Peri-vaccine sirolimus group | Experimental | Drug: Sirolimus (RAPAMUNE), Biological: Influenza vaccine (Sequiris Fluad Quad), Biological: RSV vaccine (Pfizer Abrysvo)Sirolimus 2mg orally x3/week on haemodialysis for 3 weeks. Influenza and RSV vaccination 1 week after commencing sirolimus course. |
| Post-vaccine sirolimus group | Experimental | Drug: Sirolimus (RAPAMUNE), Biological: Influenza vaccine (Sequiris Fluad Quad), Biological: RSV vaccine (Pfizer Abrysvo)Sirolimus 2mg orally x3/week on haemodialysis for 3 weeks. Influenza and RSV vaccination 2 weeks prior to commencing sirolimus course. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- End-stage kidney disease requiring in-centre haemodialysis three times per week as kidney replacement therapy
- Aged >60 years
Key exclusion criteria (28 listed)
- Aged <60 years
- Alternative haemodialysis regimens (e.g. twice-weekly haemodialysis, second-daily home haemodialysis)
- Recent infection (<6 months) with proven Influenza A, Influenza B, or RSV
- Current use of immunosuppressive medications, including:
- Recent use of intravenous immunosuppressive medications (<6 months), including:
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 |
|---|---|---|
| Sirolimus (RAPAMUNE)Also: RapamycinAll treatment groups will receive 9 doses of 2mg sirolimus over a 3 week period, at varying times relative to vaccination. | Drug | Peri-vaccine sirolimus group, Post-vaccine sirolimus group, Pre-vaccine sirolimus group |
| Influenza vaccine (Sequiris Fluad Quad)All participants will receive a dose of the seasonal Influenza vaccine (Sequiris Fluad Quad) | Biological | Control, Peri-vaccine sirolimus group, Post-vaccine sirolimus group, Pre-vaccine sirolimus group |
| RSV vaccine (Pfizer Abrysvo)All participants will receive a dose of the RSV vaccine (Pfizer Abrysvo) | Biological | Control, Peri-vaccine sirolimus group, Post-vaccine sirolimus group, Pre-vaccine sirolimus group |
Primary outcome
Vaccine-specific functional T cell memory
Time frame: Six weeks post vaccination
The change in functional T cell memory from baseline to six weeks post vaccine dose, measured as IFN-γ spot-forming units (SFU) by ELISpot following 18-hour stimulation of PBMCs with RSV peptides.
20 secondary outcomes
Cellular immune response to vaccination
Time frame: Six weeks post vaccination
Vaccine-specific humoral immune response
Time frame: Six week post vaccination
Incidence of infection post-vaccination
Time frame: Twelve months post vaccination
Incidence of Sirolimus (Rapamycin) Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Six week post vaccination
Incidence of Immunization Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Six weeks post vaccination
Quality of life questionnaire
Time frame: Six weeks post-vaccination
Circulating IL-1β analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IFN-α2 analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IFN-γ analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating TNF-α analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating MCP-1 analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-6 analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating CXCL8 (IL-8)
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-10 analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-12p70 analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-17A analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-18 analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-23 analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating IL-33 analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
Circulating CRP analysis
Time frame: Three weeks after commencement of sirolimus (after administration of final dose of sirolimus)
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 14 May 2026.
- Individual participant dataSharing planned: Yes. Anonymized patient-level data created for the study will be available in a persistent repository upon publication. Data will be uploaded to figshare.com.
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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.
Griffith Perkins, BSc PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus (RAPAMUNE), Influenza vaccine (Sequiris Fluad Quad) and RSV vaccine (Pfizer Abrysvo) in people with Vaccine Immune Response and Haemodialysis Patients, run by Central Adelaide Local Health Network Incorporated at 3 sites 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 2 inclusion and 28 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: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Toby Coates, MBBS FRACP PhD ((08) 7074 0000, 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?
Vaccine-specific functional T cell memory (time frame: Six weeks post vaccination). 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 14 May 2026.