Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vaccine injection.
- Who it may be relevant to
- Registry conditions: Vaccination; Infection. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2
Overview
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
- Other Vaccine injection
Injection of the vaccine in chronic renal insufficiency patients.
Primary outcome measures
- Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine in each arm. [Time frame: 7 months]
Secondary outcome measures (5)
- Number of seasonal influenza virus infections in each arm at 4 weeks [Time frame: 7 months]
- Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months [Time frame: 12 months]
- Antibody titers reacting in each arm [Time frame: 7 months]
- Number of anti-vaccine antibodies inhibiting hemmagglutination [Time frame: 7 months]
- Number of neutralizing anti-vaccine antibodies [Time frame: 7 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- CHU Nice - Hôpital Pasteur 2 — Nice
Identifiers
NCT: NCT06907667 · 23-API-01