How kidney failure changes antibody responses to influenza and COVID vaccines
Official title: Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
Run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT06635525 · Data updated 2026-11-12
This project will see if adults on chronic dialysis make as much protective antibody after influenza or SARS‑CoV‑2 vaccination as people without kidney disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 146 (estimated) |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 3 sites (Milan and 2 other locations) |
| Status | Recruiting |
| Started | October 16, 2024 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT06635525 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults (18–70) on chronic hemodialysis or peritoneal dialysis for ≥3 months, or healthy adults without renal insufficiency, who are eligible for seasonal influenza vaccination and can attend scheduled follow-up visits.
✕Probably not a fit
Patients with recent influenza infection, recent immunosuppressive therapy, recent other vaccination, or unresolved systemic infection are excluded or less likely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares antibody responses after influenza and SARS‑CoV‑2 vaccination between adults on chronic dialysis and adults without kidney disease. Participants are enrolled at the time of vaccination and return for blood draws and clinical data collection at days 7, 14, 30, 60, and 120. The study includes adults aged 18–70 receiving thrice‑weekly hemodialysis or peritoneal dialysis for at least three months and matched healthy controls eligible for seasonal influenza vaccine. Laboratory testing will measure humoral (antibody) responses over time to characterize the magnitude and durability of vaccine‑induced protection.
Why it matters
Potential benefit: If successful, the results could help tailor vaccination timing or booster strategies to improve protection for people on dialysis.
How similar studies have gone: Prior research has repeatedly shown reduced antibody responses to influenza and other vaccines in dialysis patients, so this observational approach builds on established findings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 70 years * Patients undergoing thrice-weekly hemodialysis / peritoneal dialysis for at least 3 months OR healthy individuals without a history of renal insufficiency * Subjects eligible to receive a seasonal influenza vaccine * Signed informed consent for participation in the study Exclusion Criteria: * Recent influenza infection (clinically resolved less than 3 months ago). * Administration of immunosuppressive drugs in the two weeks prior to vaccination. * Administration of another vaccine in the three weeks prior to enrollment (co-administration of other vaccines with those under study does not contraindicate participation). * Systemic infection clinically resolved less than two weeks before enrollment.
Where it's running
-
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy Recruiting -
ASST Santi Paolo e Carlo
Milan, Italy Not yet recruiting -
ASST Fatebenefratelli Sacco
Milan, Italy Not yet recruiting
Study contacts
- Study coordinator: Manuel A Podesta', MD, PhD
- Email: manuel.podesta@policlinico.mi.it
- Phone: 0039 0255034568
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.