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NCT Number: NCT06635525

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

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

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Key information

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Influenza, Human Kidney Diseases Male Urogenital Diseases Orthomyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urologic Diseases Vaccine Response Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Fatebenefratelli Sacco, Milan, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Influenza vaccination

Biological

Single-dose

SARS-CoV-2 vaccine

Biological

Single-dose

Primary outcomes

  1. Frequency of serological response to influenza vaccination

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

Secondary outcomes

  1. Titer of influenza-specific antibodies after vaccination

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

  2. 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

  3. 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

  4. 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

  5. Single-cell transcriptome expression in circulating T follicular helper cell subsets

    Time frame: From enrollment to 120±5 days after vaccination

Other outcomes

  1. SARS-CoV-2-specific antibody concentration after vaccination

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

  2. Correlation between virus-specific antibody concentration after SARS-CoV-2 vaccination and the frequency of circulating T follicular helper cell subsets

    Time frame: From enrollment to 120±5 days after vaccination

  3. Degree of antigen-specific activation of T follicular helper and B cells in vitro after SARS-CoV-2 vaccination

    Time frame: From enrollment to 120±5 days after vaccination

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Castellano, MD, PhD

CONTACT

[email protected]

Manuel A Podesta', MD, PhD

CONTACT

[email protected]

0039 0255034568

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • Fondazione Cariplo

Registry information

Acronym: Tfh-CKD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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