How kidney failure changes antibody responses to influenza and COVID vaccines
Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
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 |
|---|---|
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 3 sites (Milan and 2 other locations) |
| Trial ID | NCT06635525 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Prior research has repeatedly shown reduced antibody responses to influenza and other vaccines in dialysis patients, so this observational approach builds on established findings.
Eligibility criteria
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 this trial is running
Milan and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.