Dialysis patients may get better vaccine protection with a common transplant drug

NCT ID NCT07587801

Disease control Sponsor: Central Adelaide Local Health Network Incorporated Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking a short course of the drug sirolimus (Rapamycin) can improve how well older adults on hemodialysis respond to flu and RSV vaccines. Sixty participants will receive the vaccines plus sirolimus at different times. The goal is to see if this approach strengthens immune memory against these viruses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: sirolimus (Rapamycin)
What this could lead to: If it works, this could point toward a way to improve vaccine protection for people with weakened immune systems, like those on dialysis.
What could go wrong: This is a small, early-phase trial (60 people) and the drug may not improve vaccine response or could cause side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * End-stage kidney disease requiring in-centre haemodialysis three times per week as kidney replacement therapy * Aged \>60 years Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

end stage renal failure influenza

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haemodialysis patients Older adults Vaccine immune response

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Dialysis patients may get better vaccine protection with a common transplant drug

What the study statuses mean