Immune response to influenza vaccine in patients with chronic renal insufficiency.
Seasonal influenza vaccination is recommended for patients with chronic renal insufficiency, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. However, the immune response to this vaccination is limited in this population. There are currently no recommendations concerning the timing of influenza vaccine in the general population or in immunocompromised patients. In this context, recent studies have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza and COVID vaccinations. On this basis, our main hypothesis is that the administration of influenza vaccine to patients with chronic kidney failure is more effective in the morning than in the evening.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
735
Injection of the vaccine in chronic renal insufficiency patients.
CHU Nice - Hôpital Pasteur 2
Nice, Alpes-Maritimes, France
RECRUITINGAntibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine 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.
Time frame: 7 months
Number of seasonal influenza virus infections in each arm at 4 weeks
Comparing the number of seasonal influenza virus infections in each arm between a group of patients vaccinated in the morning and a group vaccinated in the evening at 4 weeks. The occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.
Time frame: 7 months
Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months
Comparing the number of seasonal influenza virus infections in patients with chronic renal failure between a group of patients vaccinated in the morning and a group vaccinated in the evening in the 6 months following vaccination. The occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.
Time frame: 12 months
Antibody titers reacting in each arm
In patients with chronic renal failure, 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
Number of anti-vaccine antibodies inhibiting hemmagglutination
4 weeks after influenza vaccine injection, compare hemmagglutination-inhibiting anti-vaccine antibody titer in CKD patients vaccinated in the morning and evening. The titer of hemagglutination-inhibiting anti-vaccine antibodies will be determined by hemagglutination inhibition test
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Time frame: 7 months
Number of neutralizing anti-vaccine antibodies
To compare, 4 weeks after influenza vaccine injection, the titer of neutralizing antivaccine antibodies in CKD patients vaccinated in the morning and evening. The titer of neutralizing anti-vaccine antibodies will be determined by a pseudo-neutralization test.
Time frame: 7 months