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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Vaccination; Infection

Treatments: Other: Vaccine injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06088563

23-PP-09

Details and patient eligibility

About

Immune response to influenza vaccine in kidney transplant patients

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Morning injection

Active Comparator group

Description:

EFLUELDA influenza vaccine injection between 07:00 am and 09:00 am.

Treatment:

Other: Vaccine injection

Evening injection

Active Comparator group

Description:

EFLUELDA influenza vaccine injection between 07:00 pm and 09:00 pm.

Treatment:

Other: Vaccine injection