Actively Recruiting
Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2026-03-30
146
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead Sponsor
F
Fondazione Cariplo
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how kidney failure influences the body's immune response to vaccination, specifically focusing on patients who require chronic dialysis. Researchers will compare how well the flu vaccine triggers protective antibodies in patients undergoing hemodialysis or peritoneal dialysis against those without chronic kidney disease. The study is observational and seeks to clarify the impact of kidney failure on vaccine effectiveness. Participants will receive a single dose of the influenza vaccine and may also be evaluated for a single dose of the SARS-CoV-2 vaccine. The study includes three groups: patients on thrice-weekly hemodialysis, patients on peritoneal dialysis, and healthy individuals without kidney disease. There is no treatment assignment since it is an observational study, and participants are enrolled at the time of their influenza vaccination. After vaccination, participants will visit the clinic at 7, 14, 30, 60, and 120 days to provide clinical information and blood samples. Researchers will measure antibody responses and immune cell activity over time, focusing mainly on the frequency of serological response within 30 days and other immune markers up to 120 days. The total participation duration spans about four months, including safety and immune response monitoring.
CONDITIONS
Brief Title
Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Patients undergoing thrice-weekly hemodialysis or peritoneal dialysis for at least 3 months OR healthy individuals without kidney disease
- Eligible to receive a seasonal influenza vaccine
- Signed informed consent for participation in the study
You will not qualify if you...
- Recent influenza infection resolved less than 3 months ago
- Use of immunosuppressive drugs within 2 weeks before vaccination
- Receipt of another vaccine within 3 weeks before enrollment
- Systemic infection resolved less than 2 weeks before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single dose of influenza vaccine and a single dose of SARS-CoV-2 vaccine.
1 vaccination visit (in-person)
Duration - Up to 120±5 days after vaccination
Participants are monitored for immune response and antibody levels after vaccination.
Approximately 3 to 4 visits for blood sampling and assessments
Trial Site Locations
Total: 3 locations
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
2
ASST Santi Paolo e Carlo
Milan, Italy, 20142
Not Yet Recruiting
3
ASST Fatebenefratelli Sacco
Milan, Italy, 20157
Not Yet Recruiting
Research Team
M
Manuel A Podesta', MD, PhD
G
Giuseppe Castellano, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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