Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure (CHRONOVAX2)

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

Immune response to influenza vaccine in patients with chronic renal insufficiency.

Study Overview

• Status: Recruiting
• Conditions: Vaccination; Infection
• Intervention / Treatment: Other: Vaccine injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 735
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GOSSET Clément, MD; Phone Number: +33 492038632; Email: gosset.c@chu-nice.fr

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06000
      • Recruiting
      • CHU Nice - Hôpital Pasteur 2
      • Contact: Clément GOSSET, MD; Phone Number: +33 492037918; Email: gosset.c@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Morning injection; VAXIGRIPTETRA influenza vaccine injection between 07:00 am and 11:00 am.	Other: Vaccine injection; Injection of the vaccine in chronic renal insufficiency patients.; Other Names: VAXIGRIPTETRA - quadrivalent inactivated influenza vaccine.
Active Comparator: Evening injection; VAXIGRIPTETRA influenza vaccine injection between 05:00 pm and 09:00 pm.	Other: Vaccine injection; Injection of the vaccine in chronic renal insufficiency patients.; Other Names: VAXIGRIPTETRA - quadrivalent inactivated influenza vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 months
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.	12 months
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	7 months
Number of neutralizing anti-vaccine antibodies	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.	7 months
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 ;	7 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: GOSSET Clément, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Influenza; Vaccination; chronic renal insufficiency
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Influenza, Human; Infections; Renal Insufficiency, Chronic; Biological Products; Complex Mixtures; Vaccines
• Other Study ID Numbers: 23-API-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No