Vaccination; Infection
Conditions
Keywords
Influenza, chronic renal insufficiency, Vaccination
Brief summary
Immune response to influenza vaccine in patients with chronic renal insufficiency.
Detailed description
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.
Interventions
OTHERVaccine injection
Injection of the vaccine in chronic renal insufficiency patients.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Known hypersensitivity to influenza vaccine or egg proteins; * Previous influenza vaccination for the current season; * Current infection; * Current acute illness; * Treatments with a major impact on vaccine response: * Treatment of rejection within the previous 3 months; * Renal transplantation with induction performed within the previous 6 months; * Immunosuppressive treatment including CTLA4 agonist, complement inhibitor, anti-CD20; * Treatments that may distort the serological response: Polyvalent immunoglobulin infusion within the preceding 3 months; * Vulnerable persons (minors, adults under guardianship or trusteeship, persons deprived of their liberty, persons unable to speak French); * Subjects not affiliated to Social Security.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine in each arm. | 7 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of seasonal influenza virus infections in each arm at 4 weeks | 7 months | 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 | 12 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 | 7 months | 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 | 7 months | 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 |
| Number of neutralizing anti-vaccine antibodies | 7 months | 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. |
Countries
France
Contacts
CONTACTGOSSET Clément, MD
PRINCIPAL_INVESTIGATORGOSSET Clément, MD
Centre Hospitalier Universitaire de Nice
Outcome results
None listed