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

NCT06907667 | Recruiting

• 1 other identifier: 23-API-01
• Study Type: interventional
• Target: 735
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaccination; Infection

Keywords

Influenza; chronic renal insufficiency; Vaccination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of seasonal influenza virus infections in each arm at 4 weeks

  7 months

• Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months

  12 months

• Antibody titers reacting in each arm

  7 months

• Number of anti-vaccine antibodies inhibiting hemmagglutination

  7 months

• Number of neutralizing anti-vaccine antibodies

  7 months

Study Arms (2)

Morning injection

ACTIVE COMPARATOR

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

Other: Vaccine injection

Evening injection

ACTIVE COMPARATOR

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

Other: Vaccine injection

Interventions

Vaccine injection OTHER

Injection of the vaccine in chronic renal insufficiency patients.

Also known as: VAXIGRIPTETRA - quadrivalent inactivated influenza vaccine.

Evening injection; Morning injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU Nice - Hôpital Pasteur 2

Nice, Alpes-Maritimes, 06000, France

RECRUITING

MeSH Terms

Conditions

Infections; Influenza, Human; Renal Insufficiency, Chronic

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• GOSSET Clément, MD

  CHU NICE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GOSSET Clément, MD

CONTACT

492038632; gosset.c@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: September 3, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (1)