Back to resultsStudy of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX (CHRONOVAX)
Primary Purpose
Vaccination; Infection
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vaccine injection
Sponsored by
About this trial
This is an interventional prevention trial for Vaccination; Infection focused on measuring Influenza, Kidney transplant, Vaccination
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Morning injection
Evening injection
Arm Description
EFLUELDA influenza vaccine injection between 07:00 am and 09:00 am.
EFLUELDA influenza vaccine injection between 07:00 pm and 09:00 pm.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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 ;
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 ;
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;
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;
Full Information
NCT ID
NCT06088563
First Posted
October 6, 2023
Last Updated
October 12, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT06088563
Brief Title
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX
Acronym
CHRONOVAX
Official Title
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2, 2023 (Anticipated)
Primary Completion Date
November 2, 2024 (Anticipated)
Study Completion Date
November 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination; Infection
Keywords
Influenza, Kidney transplant, Vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morning injection
Arm Type
Active Comparator
Arm Description
EFLUELDA influenza vaccine injection between 07:00 am and 09:00 am.
Arm Title
Evening injection
Arm Type
Active Comparator
Arm Description
EFLUELDA influenza vaccine injection between 07:00 pm and 09:00 pm.
Intervention Type
Other
Intervention Name(s)
Vaccine injection
Other Intervention Name(s)
EFLUELDA - Fluzone High-Dose Quadrivalent
Intervention Description
Injection of the vaccine in renal transplant patients.
Primary Outcome Measure Information:
Title
Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection in each arm.
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Number of seasonal influenza virus infections in each arm.
Description
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.
Time Frame
8 months
Title
Comparison the evolution of antibody titres reacting in each arm.
Description
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 ;
Time Frame
7 months
Title
Evolution of the number of memory B cells in each arm.
Description
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 ;
Time Frame
7 months
Title
Evolution of the number of CD4+ T cells in each arm.
Description
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;
Time Frame
7 months
Title
Evolution of the number of CD8+ T cells in each arm.
Description
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;
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GOSSET Clément, MD
Phone
492038632
Ext
+33
Email
gosset.c@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GOSSET Clément, MD
Organizational Affiliation
CHU Nice
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX
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