Clinical trial NCT06635525: IMPACT OF KIDNEY FAILURE ON THE REGULATION OF HUMORAL RESPONSE TO VACCINATION
Official title: IMPACT OF KIDNEY FAILURE ON THE REGULATION OF HUMORAL RESPONSE TO VACCINATION
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Vaccine Response
Keywords: Vaccine
Influenza
Chronic Kidney Disease
Hemodialysis
Peritoneal dialysis
Humoral Response
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: Fondazione Cariplo
First posted: 2024-10-10
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study populations consist of (1) subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis, (2) subjects with advanced chronic kidney disease on peritoneal dialysis, and (3) subjects without a prior medical history of chronic kidney disease, who are eligible to receive an influenza vaccine according to standard clinical practice guidelines.

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


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.

Primary outcomes:
measure: Frequency of serological response to influenza vaccination
timeFrame: From enrollment to 30±3 days after vaccination
Secondary outcomes:
measure: Titer of influenza-specific antibodies after vaccination
timeFrame: From enrollment to 30±3 days after vaccination
measure: Correlation between virus-specific antibody concentration after influenza vaccination and the frequency of circulating T follicular helper cell subsets
timeFrame: From enrollment to 120±5 days after vaccination
measure: Degree of antigen-specific activation of T follicular helper and B cells in vitro after influenza vaccination
timeFrame: From enrollment to 120±5 days after vaccination
measure: Degree of polyclonal activation of T follicular helper and B cells in vitro after exposure to the serum of subjects vaccinated against influenza
timeFrame: From enrollment to 120±5 days after vaccination
measure: Single-cell transcriptome expression in circulating T follicular helper cell subsets
timeFrame: From enrollment to 120±5 days after vaccination
Other outcomes:
measure: SARS-CoV-2-specific antibody concentration after vaccination
timeFrame: From enrollment to 30±3 days after vaccination
measure: Correlation between virus-specific antibody concentration after SARS-CoV-2 vaccination and the frequency of circulating T follicular helper cell subsets
timeFrame: From enrollment to 120±5 days after vaccination
measure: Degree of antigen-specific activation of T follicular helper and B cells in vitro after SARS-CoV-2 vaccination
timeFrame: From enrollment to 120±5 days after vaccination
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
Study officials:
References: