Clinical trial NCT06907667: Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure
Official title: Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaccination; Infection
Keywords: Influenza
chronic renal insufficiency
Vaccination
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 735
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility 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.

Primary outcomes:
measure: Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine in each arm.
timeFrame: 7 months
Secondary outcomes:
measure: Number of seasonal influenza virus infections in each arm at 4 weeks
timeFrame: 7 months
measure: Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months
timeFrame: 12 months
measure: Antibody titers reacting in each arm
timeFrame: 7 months
measure: Number of anti-vaccine antibodies inhibiting hemmagglutination
timeFrame: 7 months
measure: Number of neutralizing anti-vaccine antibodies
timeFrame: 7 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU Nice - Hôpital Pasteur 2
state: Alpes-Maritimes
Study officials:
affiliation: CHU NICE
name: GOSSET Clément, MD
role: PRINCIPAL_INVESTIGATOR
References: