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

NCT ID: NCT06088563

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2024-06-19

Brief Summary

Immune response to influenza vaccine in kidney transplant patients

Detailed 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.

Conditions

Vaccination; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Morning injection

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

Group Type: ACTIVE_COMPARATOR

Vaccine injection

Intervention Type: OTHER

Injection of the vaccine in renal transplant patients.

Evening injection

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

Group Type: ACTIVE_COMPARATOR

Vaccine injection

Intervention Type: OTHER

Injection of the vaccine in renal transplant patients.

Interventions

Vaccine injection

Injection of the vaccine in renal transplant patients.

Intervention Type: OTHER

Other Intervention Names

EFLUELDA - Fluzone High-Dose Quadrivalent

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GOSSET Clément, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NICE

Locations

CHU Nice - Hôpital Pasteur 2

Nice, Alpes-Maritimes, France

Countries

France

Other Identifiers

23-PP-09

Identifier Type: -

Identifier Source: org_study_id