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Immune response to influenza vaccine in kidney transplant patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning injection | Active Comparator | EFLUELDA influenza vaccine injection between 07:00 am and 09:00 am. |
|
| Evening injection | Active Comparator | EFLUELDA influenza vaccine injection between 07:00 pm and 09:00 pm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine injection | Other | Injection of the vaccine in renal transplant patients. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GOSSET Clément, MD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nice - Hôpital Pasteur 2 | Nice | Alpes-Maritimes | 06000 | France |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 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 |
| D012140 | Respiratory Tract Diseases |