Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination (Tfh-CKD)

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 Overview

• Status: Recruiting
• Conditions: Vaccine Response; Chronic Kidney Disease Requiring Chronic Dialysis
• Intervention / Treatment: Biological: Influenza vaccination; Biological: SARS-CoV-2 vaccine

• Study Type: Observational
• Enrollment (Estimated): 146

Contacts and Locations

• Study Contact: Name: Manuel A Podesta', MD, PhD; Phone Number: 0039 0255034568; Email: manuel.podesta@policlinico.mi.it
• Study Contact Backup: Name: Giuseppe Castellano, MD, PhD; Email: giuseppe.castellano@policlinico.mi.it

Study Locations

• Italy
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Milan, Italy, 20142
    • Not yet recruiting
    • Asst Santi Paolo E Carlo
  • Milan, Italy, 20157
    • Not yet recruiting
    • Asst Fatebenefratelli Sacco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemodialysis patients; Subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis	Biological: Influenza vaccination; Single-dose; Biological: SARS-CoV-2 vaccine; Single-dose
Peritoneal dialysis patients; Subjects with advanced chronic kidney disease on peritoneal dialysis	Biological: Influenza vaccination; Single-dose; Biological: SARS-CoV-2 vaccine; Single-dose
Healthy controls; Subjects without a prior history of chronic kidney disease	Biological: Influenza vaccination; Single-dose; Biological: SARS-CoV-2 vaccine; Single-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of serological response to influenza vaccination	From enrollment to 30±3 days after vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Titer of influenza-specific antibodies after vaccination	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	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	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	From enrollment to 120±5 days after vaccination
Single-cell transcriptome expression in circulating T follicular helper cell subsets	From enrollment to 120±5 days after vaccination

Other Outcome Measures

Outcome Measure	Time Frame
SARS-CoV-2-specific antibody concentration after vaccination	From enrollment to 30±3 days after vaccination
Correlation between virus-specific antibody concentration after SARS-CoV-2 vaccination and the frequency of circulating T follicular helper cell subsets	From enrollment to 120±5 days after vaccination
Degree of antigen-specific activation of T follicular helper and B cells in vitro after SARS-CoV-2 vaccination	From enrollment to 120±5 days after vaccination

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Collaborators: Fondazione Cariplo

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; Chronic Kidney Disease; Hemodialysis; Peritoneal dialysis; Humoral Response
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Influenza, Human; Renal Insufficiency, Chronic; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Influenza Vaccines; COVID-19 Vaccines
• Other Study ID Numbers: 5281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No