Morning versus evening flu vaccination for adults with chronic kidney failure

Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2

This trial will test whether giving the seasonal flu shot in the morning produces a stronger immune response than giving it in the evening for adults with advanced chronic kidney disease, people on dialysis, and kidney transplant recipients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 735 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (other)
• Locations: 1 site (Nice, Alpes-Maritimes)
• Trial ID: NCT06907667 on ClinicalTrials.gov

What this trial studies

Seasonal influenza vaccination is recommended for people with chronic renal insufficiency, but antibody responses are often weaker in this group. Recent research suggests the time of day of vaccination can influence immune responses. In this single-center interventional study at CHU Nice, eligible participants will receive the influenza vaccine either in the morning or in the evening and have blood samples taken to compare serological responses. The goal is to determine whether morning administration yields higher antibody levels than evening administration in this immunocompromised population.

Who should consider this trial

Good fit: Adults (≥18 years) with stage 4 or 5 chronic kidney disease, patients on dialysis, or kidney transplant recipients who need the seasonal influenza vaccine and can give informed consent.

Not a fit: Patients with known hypersensitivity to the influenza vaccine or egg proteins, those who already received this season's vaccine, those with current infection or acute illness, or those recently on major immunosuppressive or immunomodulatory therapies are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, scheduling flu vaccinations at the best time of day could boost protection and reduce influenza-related complications in people with advanced kidney disease.

How similar studies have performed: Prior studies have reported time-of-day effects on vaccine responses for BCG, influenza, and COVID vaccines, but this timing strategy has not been definitively proven in people with advanced kidney disease.

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.

Where this trial is running

Nice, Alpes-Maritimes

• CHU Nice - Hôpital Pasteur 2 — Nice, Alpes-Maritimes, France (RECRUITING)

Study contacts

• Principal investigator: GOSSET Clément, MD — Centre Hospitalier Universitaire de Nice
• Study coordinator: GOSSET Clément, MD

Conditions: Vaccination, Infection, Influenza, chronic renal insufficiency