IMPACT OF KIDNEY FAILURE ON THE REGULATION OF HUMORAL RESPONSE TO VACCINATION

N/ANot Yet RecruitingNCT06635525

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico146 enrolled

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

Study Type

OBSERVATIONAL

Enrollment

146

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis Vaccine Response

Interventions

Influenza vaccinationBIOLOGICAL

Single-dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

ASST Santi Paolo e Carlo

Milan, Italy

ASST Fatebenefratelli Sacco

Milan, Italy

Outcomes

Primary Outcomes

Frequency of serological response to influenza vaccination

Time frame: From enrollment to 30±3 days after vaccination

Secondary Outcomes

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

Central Contacts

Manuel A Podesta', MD, PhD

CONTACT

0039 0255034568 manuel.podesta@policlinico.mi.it

Giuseppe Castellano, MD, PhD

CONTACT

giuseppe.castellano@policlinico.mi.it