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Clinical Trials in Italy / NCT06635525
Recruiting Observational

Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination

NCT06635525 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-10-16
Last updated
2026-03-30

Condition(s) studied

Chronic Kidney Disease Requiring Chronic DialysisVaccine Response

Investigational drug(s) / intervention(s)

Influenza vaccination →SARS-CoV-2 vaccine

Influenza vaccination: Single-dose

SARS-CoV-2 vaccine: Single-dose

Study summary

The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis.

Researchers will compare the effectiveness of the influenza vaccine in inducing protective antibodies between hemodialysis patients and subjects without chronic kidney disease.

Participants will:

* Be enrolled at the time of influenza vaccination
* Visit the clinic at 7, 14, 30, 60, and 120 days after vaccination
* Be asked to provide relevant clinical information and a blood sample at each visit

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
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

More Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06635525 on ClinicalTrials.gov ↗ ← All trials in Italy