IMPACT OF KIDNEY FAILURE ON THE REGULATION OF HUMORAL RESPONSE TO VACCINATION
Not yet recruiting
- Conditions
- Chronic Kidney Disease Requiring Chronic DialysisVaccine Response
- Interventions
- Biological: Influenza vaccination
- Registration Number
- NCT06635525
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 146
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hemodialysis patients Influenza vaccination Subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis Hemodialysis patients SARS-CoV-2 vaccine Subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis Peritoneal dialysis patients Influenza vaccination Subjects with advanced chronic kidney disease on peritoneal dialysis Peritoneal dialysis patients SARS-CoV-2 vaccine Subjects with advanced chronic kidney disease on peritoneal dialysis Healthy controls Influenza vaccination Subjects without a prior history of chronic kidney disease Healthy controls SARS-CoV-2 vaccine Subjects without a prior history of chronic kidney disease
- Primary Outcome Measures
Name Time Method Frequency of serological response to influenza vaccination From enrollment to 30±3 days after vaccination
- Secondary Outcome Measures
Name Time Method Titer of influenza-specific antibodies after vaccination From enrollment to 30±3 days after vaccination Correlation between virus-specific antibody concentration after influenza vaccination and the frequency of circulating T follicular helper cell subsets From enrollment to 120±5 days after vaccination Degree of antigen-specific activation of T follicular helper and B cells in vitro after influenza vaccination From enrollment to 120±5 days after vaccination Degree of polyclonal activation of T follicular helper and B cells in vitro after exposure to the serum of subjects vaccinated against influenza From enrollment to 120±5 days after vaccination Single-cell transcriptome expression in circulating T follicular helper cell subsets From enrollment to 120±5 days after vaccination
Trial Locations
- Locations (3)
ASST Santi Paolo e Carlo
🇮🇹Milano, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
ASST Fatebenefratelli Sacco
🇮🇹Milano, Italy