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

Not Applicable

Completed

• Conditions: Vaccination; Infection
• Interventions: Other: Vaccine injection

• Registration Number: NCT06088563
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Study Timeline

• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Study Start: 2023-10-26
• Primary Completion: 2024-06-19
• Study Completion: 2024-06-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evening injection	Vaccine injection	EFLUELDA influenza vaccine injection between 07:00 pm and 09:00 pm.
Morning injection	Vaccine injection	EFLUELDA influenza vaccine injection between 07:00 am and 09:00 am.

Primary Outcome Measures

Name	Time	Method
Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection in each arm.	7 months	Seroconversion will be defined as an increase in antibody titer of at least 4-fold (≥4) over pre-vaccination titer AND an antibody titer ≥ 1:40 (seroprotection) four weeks post-vaccination, for at least one of the three vaccine antigens.

Secondary Outcome Measures

Name	Time	Method
Number of seasonal influenza virus infections in each arm.	8 months	Comparing the number of seasonal influenza virus infections in kidney transplant patients between a group of patients vaccinated in the morning and a group vaccinated in the evening.; The occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.
Comparison the evolution of antibody titres reacting in each arm.	7 months	In kidney transplant patients, compare the evolution of antibody titres reacting with vaccine antigens 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.; The titer of antibodies reacting with vaccine antigens is measured by ELISA ;
Evolution of the number of CD4+ T cells in each arm.	7 months	Comparing the evolution of CD4+ T cells reacting with vaccine antigens in kidney transplant patients 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.; The number of CD4+ T cells reacting with vaccine antigens will be measured by in vitro proliferation assay;
Evolution of the number of memory B cells in each arm.	7 months	To compare in kidney transplant patients the evolution of the number of memory B cells reacting with vaccine antigens 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.; The number of memory B cells reacting with vaccine antigens will be measured by ELISPOT ;
Evolution of the number of CD8+ T cells in each arm.	7 months	Comparing the evolution of CD8+ T cells reacting with vaccine antigens in kidney transplant patients 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.; The number of CD8+ T cells reacting with vaccine antigens will be measured by in vitro proliferation assay;

Trial Locations

Locations (1)

CHU Nice - Hôpital Pasteur 2; 🇫🇷 Nice, Alpes-Maritimes, France