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IMPACT OF KIDNEY FAILURE ON THE REGULATION OF HUMORAL RESPONSE TO VACCINATION (Tfh-CKD)

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Not yet enrolling

Conditions

Vaccine Response
Chronic Kidney Disease Requiring Chronic Dialysis

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

146 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

146 participants in 3 patient groups

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

Trial contacts and locations

3

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Central trial contact

Giuseppe Castellano, MD, PhD; Manuel A Podesta', MD, PhD

Data sourced from clinicaltrials.gov

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