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

Immune response to influenza vaccine in kidney transplant patients

Study Overview

• Status: Completed
• Conditions: Vaccination; Infection
• Intervention / Treatment: Other: Vaccine injection

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06000
      • CHU Nice - Hôpital Pasteur 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Morning injection; EFLUELDA influenza vaccine injection between 07:00 am and 09:00 am.	Other: Vaccine injection; Injection of the vaccine in renal transplant patients.; Other Names: EFLUELDA - Fluzone High-Dose Quadrivalent
Active Comparator: Evening injection; EFLUELDA influenza vaccine injection between 07:00 pm and 09:00 pm.	Other: Vaccine injection; Injection of the vaccine in renal transplant patients.; Other Names: EFLUELDA - Fluzone High-Dose Quadrivalent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection in each arm.	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.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of seasonal influenza virus infections in each arm.	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.	8 months
Comparison the evolution of antibody titres reacting in each arm.	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 ;	7 months
Evolution of the number of memory B cells in each arm.	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 ;	7 months
Evolution of the number of CD4+ T cells in each arm.	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;	7 months
Evolution of the number of CD8+ T cells in each arm.	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;	7 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: GOSSET Clément, MD, CHU Nice

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Actual): June 19, 2024
• Study Completion (Actual): June 19, 2024

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Influenza; Vaccination; Kidney transplant
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: 23-PP-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No