Vaccination Response Modulation With a Targeted Rapamycin Protocol Study
NCT07587801 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-14
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. 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.
Conditions
- Vaccine Immune Response
- Haemodialysis Patients
- Older Adults
Interventions
- DRUG
-
Sirolimus (RAPAMUNE)
All treatment groups will receive 9 doses of 2mg sirolimus over a 3 week period, at varying times relative to vaccination.
- BIOLOGICAL
-
Influenza vaccine (Sequiris Fluad Quad)
All participants will receive a dose of the seasonal Influenza vaccine (Sequiris Fluad Quad)
- BIOLOGICAL
-
RSV vaccine (Pfizer Abrysvo)
All participants will receive a dose of the RSV vaccine (Pfizer Abrysvo)
Sponsors & Collaborators
-
Central Adelaide Local Health Network Incorporated
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
Countries
- Australia
Study Locations
More Related Trials
-
Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus
NCT00248313 ·Status: COMPLETED ·Phase: PHASE3
-
The Vienna RAP Pilot Study
NCT01632605 ·Status: COMPLETED ·Phase: NA
-
Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
NCT00518271 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
NCT00895583 ·Status: COMPLETED ·Phase: PHASE4
-
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
NCT01236378 ·Status: COMPLETED ·Phase: PHASE1
-
Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy
NCT00920309 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation
NCT07033858 ·Status: RECRUITING ·Phase: NA
-
Study Evaluating Rapamune in Patients After Kidney Transplantation
NCT00240214 ·Status: TERMINATED
-
Study Investigating Rapamune For Post-Marketing Surveillance
NCT00484094 ·Status: COMPLETED
-
Study to Evaluate Safety and Immunologic Biomarker of Rapamune in Patients With Stable Renal Transplant Recipient
NCT01592253 ·Status: UNKNOWN ·Phase: NA
-
Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients
NCT00044720 ·Status: COMPLETED ·Phase: PHASE4
-
Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
NCT00273871 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries
NCT00195195 ·Status: COMPLETED
-
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
NCT00195468 ·Status: COMPLETED ·Phase: PHASE4
-
Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients
NCT00866879 ·Status: COMPLETED ·Phase: PHASE4
-
Study Evaluating Sirolimus in Kidney Transplant Recipients in India
NCT00195481 ·Status: COMPLETED ·Phase: PHASE4
-
Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease
NCT02055079 ·Status: UNKNOWN ·Phase: PHASE3
-
Study Evaluating Conversion From Tacrolimus to Sirolimus in Stable Kidney Transplant Recipients Receiving Myfortic
NCT00713284 ·Status: COMPLETED ·Phase: PHASE4
-
TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients
NCT00133887 ·Status: COMPLETED ·Phase: PHASE3
-
Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
NCT00123331 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Sirolimus Plus CNI Compared With MMF Plus CNI in ABO-i Kidney Transplant Recipients.
NCT04700709 ·Status: UNKNOWN ·Phase: PHASE4
-
Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus
NCT00518375 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients
NCT05193565 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic Risk
NCT00138970 ·Status: COMPLETED ·Phase: PHASE4
-
Kidney Biopsy Controlled Trial of Calcineurin Inhibitor Withdrawal
NCT00896012 ·Status: COMPLETED ·Phase: PHASE4