Vaccination; Infection Clinical Trial
— CHRONOVAXOfficial title:
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX
Immune response to influenza vaccine in kidney transplant patients
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 26, 2024 |
Est. primary completion date | October 26, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Nice - Hôpital Pasteur 2 | Nice | Alpes-Maritimes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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