Clinical trial NCT06088563: Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX
Official title: Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination; Infection
Keywords: Influenza
Kidney transplant
Vaccination
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection in each arm.
timeFrame: 7 months
Secondary outcomes:
measure: Number of seasonal influenza virus infections in each arm.
timeFrame: 8 months
measure: Comparison the evolution of antibody titres reacting in each arm.
timeFrame: 7 months
measure: Evolution of the number of memory B cells in each arm.
timeFrame: 7 months
measure: Evolution of the number of CD4+ T cells in each arm.
timeFrame: 7 months
measure: Evolution of the number of CD8+ T cells in each arm.
timeFrame: 7 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU Nice - Hôpital Pasteur 2
state: Alpes-Maritimes
Study officials:
affiliation: CHU NICE
name: GOSSET Clément, MD
role: PRINCIPAL_INVESTIGATOR
References: