Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination

NCT06635525 | Recruiting

• 1 other identifier: 5281
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 3

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

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis; Vaccine Response

Keywords

Vaccine; Influenza; Chronic Kidney Disease; Hemodialysis; Peritoneal dialysis; Humoral Response

Outcome Measures

Primary Outcomes (1)

• Frequency of serological response to influenza vaccination

  From enrollment to 30±3 days after vaccination

Secondary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (3)

Hemodialysis patients

Subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis

Biological: Influenza vaccination; Biological: SARS-CoV-2 vaccine

Peritoneal dialysis patients

Subjects with advanced chronic kidney disease on peritoneal dialysis

Biological: Influenza vaccination; Biological: SARS-CoV-2 vaccine

Healthy controls

Subjects without a prior history of chronic kidney disease

Biological: Influenza vaccination; Biological: SARS-CoV-2 vaccine

Interventions

Influenza vaccination BIOLOGICAL

Single-dose

Healthy controls; Hemodialysis patients; Peritoneal dialysis patients

SARS-CoV-2 vaccine BIOLOGICAL

Single-dose

Healthy controls; Hemodialysis patients; Peritoneal dialysis patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• Fondazione Cariplo: collaborator

Study Sites (3)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

ASST Santi Paolo e Carlo

Milan, 20142, Italy

NOT YET RECRUITING

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum and peripheral blood mononuclear cells

MeSH Terms

Conditions

Influenza, Human; Renal Insufficiency, Chronic

Interventions

Influenza Vaccines; COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Manuel A Podesta', MD, PhD

CONTACT

0039 0255034568; manuel.podesta@policlinico.mi.it

Giuseppe Castellano, MD, PhD

CONTACT

giuseppe.castellano@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

IT (3)