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
Qualifiers
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 design
Treatments tested in this trial
- Influenza vaccination
- SARS-CoV-2 vaccine
Treatment groups
146 Participants
are divided into 3 treatment groupsSponsors and collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead sponsor
Fondazione Cariplo
Collaborator
Source ClinicalTrials.gov