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Completed

NCT Number: NCT06088563

Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX

Immune response to influenza vaccine in kidney transplant patients

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nice - Hôpital Pasteur 2

Nice, Alpes-Maritimes, 06000, France

About this study

Seasonal influenza vaccination is recommended for kidney transplant patients, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. Nevertheless, injection of influenza vaccine induces a protective immune response in only 20% to 40% of patients. Today, there are no recommendations regarding the injection time of influenza vaccine in the general population or in immunocompromised patients. In this context, recent studies conducted in healthy subjects have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza, COVID-19. On this basis, we formulate the main hypothesis that the administration of influenza vaccine to kidney transplant patients would be more effective when carried out in the morning than in the evening.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Renal transplant patient;
  • Follow-up at Nice University Hospital;
  • Age > 18 years;
  • Indication for influenza vaccination
  • Free and informed consent;
  • Immunosuppressive treatment including anti-calcineurin and/or Mycophenolate Mofetil (with or without corticoids).

Exclusion criteria

  • Known hypersensitivity to influenza vaccine or egg proteins;
  • Influenza vaccination for the 2023-2024 season already performed;
  • Current infection;
  • Current acute medical condition;
  • Treatment of rejection within the previous 3 months;
  • Immunosuppressive therapy including CTLA4 agonist, mTOR inhibitor, complement inhibitor, anti-CD19;
  • Polyvalent immunoglobulin infusion within the preceding 3 months;
  • Vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French);
  • Subjects not affiliated to the Social Security system.

Treatment and study plan

Vaccine injection

Other

Injection of the vaccine in renal transplant patients.

Other names: EFLUELDA - Fluzone High-Dose Quadrivalent

Primary outcomes

  1. Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection in each arm.

    Time frame: 7 months

    Seroconversion will be defined as an increase in antibody titer of at least 4-fold (≥4) over pre-vaccination titer AND an antibody titer ≥ 1:40 (seroprotection) four weeks post-vaccination, for at least one of the three vaccine antigens.

Secondary outcomes

  1. Number of seasonal influenza virus infections in each arm.

    Time frame: 8 months

    Comparing the number of seasonal influenza virus infections in kidney transplant patients between a group of patients vaccinated in the morning and a group vaccinated in the evening.

    The occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.

  2. Comparison the evolution of antibody titres reacting in each arm.

    Time frame: 7 months

    In kidney transplant patients, compare the evolution of antibody titres reacting with vaccine antigens 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.

    The titer of antibodies reacting with vaccine antigens is measured by ELISA ;

  3. Evolution of the number of memory B cells in each arm.

    Time frame: 7 months

    To compare in kidney transplant patients the evolution of the number of memory B cells reacting with vaccine antigens 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.

    The number of memory B cells reacting with vaccine antigens will be measured by ELISPOT ;

  4. Evolution of the number of CD4+ T cells in each arm.

    Time frame: 7 months

    Comparing the evolution of CD4+ T cells reacting with vaccine antigens in kidney transplant patients 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.

    The number of CD4+ T cells reacting with vaccine antigens will be measured by in vitro proliferation assay;

  5. Evolution of the number of CD8+ T cells in each arm.

    Time frame: 7 months

    Comparing the evolution of CD8+ T cells reacting with vaccine antigens in kidney transplant patients 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.

    The number of CD8+ T cells reacting with vaccine antigens will be measured by in vitro proliferation assay;

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: CHRONOVAX

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2023
Registry last updated
Nov 15, 2024

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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