About this trial
Immune response to influenza vaccine in patients with chronic renal insufficiency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chronic renal failure patient at stage 4 or 5 (i.e. estimated GFR < 30mL/min/1.73m2); or Dialysis patient; or renal transplant patient regardless of GFR;
Age ≥ 18 years;
Indication for influenza vaccination;
Express free and informed consent.
Disqualifiers
Known hypersensitivity to influenza vaccine or egg proteins;
Previous influenza vaccination for the current season;
Current infection;
Current acute illness;
Trial design
Parallel
Treatments tested in this trial
Vaccine injection
Other interventionInjection of the vaccine in chronic renal insufficiency patients.
Treatment groups
Trial outcomes
Primary outcomes
Antibody 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.
Secondary outcomes
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.
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.
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 ;
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
Sponsors and contacts
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