Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Influenza vaccination
Biological/VaccineSingle-dose
SARS-CoV-2 vaccine
Biological/VaccineSingle-dose
Treatment groups
146 Participants
are divided into 3 treatment groupsGroup A: Hemodialysis patients2 interventions
Group B: Peritoneal dialysis patients2 interventions
Group C: Healthy controls2 interventions
Trial outcomes
Primary outcomes
1
Frequency of serological response to influenza vaccination
Time frame
From enrollment to 30±3 days after vaccinationSecondary outcomes
1
Titer of influenza-specific antibodies after vaccination
Time frame
From enrollment to 30±3 days after vaccination2
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 vaccination3
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 vaccination4
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 vaccinationOther outcomes
1
SARS-CoV-2-specific antibody concentration after vaccination
Time frame
From enrollment to 30±3 days after vaccination2
Correlation between virus-specific antibody concentration after SARS-CoV-2 vaccination and the frequency of circulating T follicular helper cell subsets
Time frame
From enrollment to 120±5 days after vaccination3
Degree of antigen-specific activation of T follicular helper and B cells in vitro after SARS-CoV-2 vaccination
Time frame
From enrollment to 120±5 days after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead sponsor
Fondazione Cariplo
Collaborator
Source ClinicalTrials.gov