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NCT Number: NCT06907667

Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure

Immune response to influenza vaccine in patients with chronic renal insufficiency.

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Key information

About this study

Seasonal influenza vaccination is recommended for patients with chronic renal insufficiency, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. However, the immune response to this vaccination is limited in this population.

There are currently no recommendations concerning the timing of influenza vaccine in the general population or in immunocompromised patients.

In this context, recent studies have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza and COVID vaccinations.

On this basis, our main hypothesis is that the administration of influenza vaccine to patients with chronic kidney failure is more effective 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

  • Chronic renal failure patient at stage 4 or 5 (i.e. estimated GFR < 30mL/min/1.73m2); or Dialysis patient; or renal transplant patient regardless of GFR;
  • Age ≥ 18 years;
  • Indication for influenza vaccination;
  • Express free and informed consent.

Exclusion criteria

  • Known hypersensitivity to influenza vaccine or egg proteins;
  • Previous influenza vaccination for the current season;
  • Current infection;
  • Current acute illness;
  • Treatments with a major impact on vaccine response:
  • Treatment of rejection within the previous 3 months;
  • Renal transplantation with induction performed within the previous 6 months;
  • Immunosuppressive treatment including CTLA4 agonist, complement inhibitor, anti-CD20;
  • Treatments that may distort the serological response: Polyvalent immunoglobulin infusion within the preceding 3 months;
  • Vulnerable persons (minors, adults under guardianship or trusteeship, persons deprived of their liberty, persons unable to speak French);
  • Subjects not affiliated to Social Security.

Treatment and study plan

Vaccine injection

Other

Injection of the vaccine in chronic renal insufficiency patients.

Other names: VAXIGRIPTETRA - quadrivalent inactivated influenza vaccine.

Primary outcomes

  1. Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine 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 at 4 weeks

    Time frame: 7 months

    Comparing the number of seasonal influenza virus infections in each arm between a group of patients vaccinated in the morning and a group vaccinated in the evening at 4 weeks.

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

  2. Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months

    Time frame: 12 months

    Comparing the number of seasonal influenza virus infections in patients with chronic renal failure between a group of patients vaccinated in the morning and a group vaccinated in the evening in the 6 months following vaccination.

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

  3. Antibody titers reacting in each arm

    Time frame: 7 months

    In patients with chronic renal failure, 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 ;

  4. Number of anti-vaccine antibodies inhibiting hemmagglutination

    Time frame: 7 months

    4 weeks after influenza vaccine injection, compare hemmagglutination-inhibiting anti-vaccine antibody titer in CKD patients vaccinated in the morning and evening.

    The titer of hemagglutination-inhibiting anti-vaccine antibodies will be determined by hemagglutination inhibition test

  5. Number of neutralizing anti-vaccine antibodies

    Time frame: 7 months

    To compare, 4 weeks after influenza vaccine injection, the titer of neutralizing antivaccine antibodies in CKD patients vaccinated in the morning and evening.

    The titer of neutralizing anti-vaccine antibodies will be determined by a pseudo-neutralization test.

Study contacts

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

GOSSET Clément, MD

CONTACT

[email protected]

492038632 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2

Acronym: CHRONOVAX2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2025
Registry last updated
May 15, 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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