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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form for participation in the study Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

Influenza vaccination

Single-dose

BIOLOGICAL

SARS-CoV-2 vaccine

Single-dose

Locations (3)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
ASST Santi Paolo e Carlo
Milan, Italy
ASST Fatebenefratelli Sacco
Milan, Italy