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NCT06907667 | NOT YET RECRUITING | Vaccination; Infection

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

Nice University Hospital Center

Brief Summary:

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

Condition or disease

Vaccination; Infection

Intervention/treatment

Vaccine injection

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 735 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2
Actual Study Start Date : 2025-08
Estimated Primary Completion Date : 2026-02
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2

Location Details

NCT06907667

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How to Participate

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Locations

Not yet recruiting

France, Alpes-Maritimes

CHU Nice - Pasteur Hospital 2

Nice, Alpes-Maritimes, France, 06000