Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Influenza vaccination, SARS-CoV-2 vaccine.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease Requiring Chronic Dialysis, Vaccine Response. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Biological Influenza vaccination
Single-dose - Biological SARS-CoV-2 vaccine
Single-dose
Primary outcome measures
- Frequency of serological response to influenza vaccination [Time frame: From enrollment to 30±3 days after vaccination]
Secondary outcome measures (5)
- Titer of influenza-specific antibodies after vaccination [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From enrollment to 120±5 days after vaccination]
- Single-cell transcriptome expression in circulating T follicular helper cell subsets [Time frame: From enrollment to 120±5 days after vaccination]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 3 centers
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
- ASST Santi Paolo e Carlo — Milan
- ASST Fatebenefratelli Sacco — Milan
Identifiers
NCT: NCT06635525 · 5281