Vaccination Response Modulation With a Targeted Rapamycin Protocol Study
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorCentral Adelaide Local Health Network Incorporated
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
End-stage kidney disease requiring in-centre haemodialysis three times per week as kidney replacement therapy
Aged >60 years
Disqualifiers
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
Oral steroid at a dose equivalent of 5 mg/day prednisolone or greater
Trial design
Design model
Parallel
Treatments tested in this trial
Sirolimus (RAPAMUNE)
DrugAll 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/VaccineAll participants will receive a dose of the seasonal Influenza vaccine (Sequiris Fluad Quad)
RSV vaccine (Pfizer Abrysvo)
Biological/VaccineAll participants will receive a dose of the RSV vaccine (Pfizer Abrysvo)
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: ControlActive comparator 2 interventions
Group B: Pre-vaccine sirolimus groupExperimental treatment 3 interventions
Group C: Peri-vaccine sirolimus groupExperimental treatment 3 interventions
Group D: Post-vaccine sirolimus groupExperimental treatment 3 interventions
Trial outcomes
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.
Time frame
Six weeks post vaccinationSecondary outcomes
1
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).
Time frame
Six weeks post vaccination2
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.
Time frame
Six week post vaccination3
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
Time frame
Twelve months post vaccination4
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)
Time frame
Six week post vaccinationSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: