Vaccination Response Modulation With a Targeted Rapamycin Protocol Study

NCT07587801 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025/HRE00483
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

influenza; RSV; vaccine; haemodialysis; older adults; immunosenescence

Outcome Measures

Primary Outcomes (1)

• 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.

  Six weeks post vaccination

Secondary Outcomes (20)

• Cellular immune response to vaccination

  Six weeks post vaccination

• Vaccine-specific humoral immune response

  Six week post vaccination

• Incidence of infection post-vaccination

  Twelve months post vaccination

• Incidence of Sirolimus (Rapamycin) Treatment-Emergent Adverse Events [Safety and Tolerability]

  Six week post vaccination

• Incidence of Immunization Treatment-Emergent Adverse Events [Safety and Tolerability]

  Six weeks post vaccination

Study Arms (4)

Control

ACTIVE COMPARATOR

Influenza and RSV vaccination without additional treatment

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.

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.

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.

Drug: Sirolimus (RAPAMUNE); Biological: Influenza vaccine (Sequiris Fluad Quad); Biological: RSV vaccine (Pfizer Abrysvo)

Interventions

Sirolimus (RAPAMUNE) DRUG

All treatment groups will receive 9 doses of 2mg sirolimus over a 3 week period, at varying times relative to vaccination.

Also known as: Rapamycin

Peri-vaccine sirolimus group; Post-vaccine sirolimus group; Pre-vaccine sirolimus group

Influenza vaccine (Sequiris Fluad Quad) BIOLOGICAL

All participants will receive a dose of the seasonal Influenza vaccine (Sequiris Fluad Quad)

Control; Peri-vaccine sirolimus group; Post-vaccine sirolimus group; Pre-vaccine sirolimus group

RSV vaccine (Pfizer Abrysvo) BIOLOGICAL

All participants will receive a dose of the RSV vaccine (Pfizer Abrysvo)

Control; Peri-vaccine sirolimus group; Post-vaccine sirolimus group; Pre-vaccine sirolimus group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Central Adelaide Local Health Network Incorporated: lead

Study Sites (3)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Sirolimus; Influenza Vaccines; Respiratory Syncytial Virus Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Toby Coates, MBBS FRACP PhD

CONTACT

(08) 7074 0000; Toby.Coates@sa.gov.au

Griffith Perkins, BSc PhD

CONTACT

Griffith.Perkins@adelaide.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Anonymized IPD will be made available in a persistent repository from the date of publication of trial findings.
• Access Criteria: Anonymized IPD will be publicly accessible by download from the persistent repository.

Locations

AU (3)