Chronic Kidney Disease Requiring Chronic Dialysis, Vaccine Response
Conditions
Keywords
Vaccine, Influenza, Chronic Kidney Disease, Hemodialysis, Peritoneal dialysis, Humoral Response
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
Interventions
BIOLOGICALInfluenza vaccination
Single-dose
BIOLOGICALSARS-CoV-2 vaccine
Single-dose
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Fondazione Cariplo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of serological response to influenza vaccination | From enrollment to 30±3 days after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Contacts
CONTACTManuel A Podesta', MD, PhD
CONTACTGiuseppe Castellano, MD, PhD
Outcome results
None listed