RecruitingNCT06635525

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


Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Enrollment

146 participants

Start Date

Oct 16, 2024

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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Interventions

BIOLOGICALInfluenza vaccination

Single-dose

BIOLOGICALSARS-CoV-2 vaccine

Single-dose


Locations(3)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

ASST Santi Paolo e Carlo

Milan, Italy

ASST Fatebenefratelli Sacco

Milan, Italy

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NCT06635525


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