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

NCT ID: NCT06907667

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 735 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-03
• Study Completion Date: 2026-09-30

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.

Conditions

Vaccination; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Morning injection

VAXIGRIPTETRA influenza vaccine injection between 07:00 am and 11:00 am.

Group Type: ACTIVE_COMPARATOR

Vaccine injection

Intervention Type: OTHER

Injection of the vaccine in chronic renal insufficiency patients.

Evening injection

VAXIGRIPTETRA influenza vaccine injection between 05:00 pm and 09:00 pm.

Group Type: ACTIVE_COMPARATOR

Vaccine injection

Intervention Type: OTHER

Injection of the vaccine in chronic renal insufficiency patients.

Interventions

Vaccine injection

Injection of the vaccine in chronic renal insufficiency patients.

Intervention Type: OTHER

Other Intervention Names

VAXIGRIPTETRA - quadrivalent inactivated influenza vaccine.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GOSSET Clément, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NICE

Locations

CHU Nice - Hôpital Pasteur 2

Nice, Alpes-Maritimes, France

Site Status: RECRUITING

Countries

France

Central Contacts

GOSSET Clément, MD

Role: CONTACT

gosset.c@chu-nice.fr

492038632 ext. +33

Facility Contacts

Clément GOSSET, MD

Role: primary

gosset.c@chu-nice.fr

492037918 ext. +33

Other Identifiers

23-API-01

Identifier Type: -

Identifier Source: org_study_id