Vaccination Response Modulation With a Targeted Rapamycin Protocol Study
Starting soon · Phase 2
Conditions studied: Vaccine Immune Response, Haemodialysis Patients, Older Adults
In brief
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.
Key facts
- Study ID
- NCT07587801
- Run by
- Central Adelaide Local Health Network Incorporated
- People needed
- 60
- Starts
- 2026-05-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-05-14
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- End-stage kidney disease requiring in-centre haemodialysis three times per week as kidney replacement therapy
- Aged >60 years
You may not qualify if…
- 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
- 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
Where it is running
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
- Royal Adelaide Hospital — Adelaide, South Australia, Australia
Full record on ClinicalTrials.gov
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