Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
Recruiting · NCT06635525 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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 is running
3 locations listed.
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milan, Italy
- ASST Santi Paolo e Carlo - Milan, Italy
- ASST Fatebenefratelli Sacco - Milan, Italy