Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure (CHRONOVAX2)

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Vaccination; Infection

Treatments: Other: Vaccine injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06907667

23-API-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 735 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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735 participants in 2 patient groups

Morning injection

Active Comparator group

Description:

VAXIGRIPTETRA influenza vaccine injection between 07:00 am and 11:00 am.

Treatment:

Other: Vaccine injection

Evening injection

Active Comparator group

Description:

VAXIGRIPTETRA influenza vaccine injection between 05:00 pm and 09:00 pm.

Treatment:

Other: Vaccine injection