Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX

NCT06088563 | Completed

• 1 other identifier: 23-PP-09
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Immune response to influenza vaccine in kidney transplant patients

Conditions

Vaccination; Infection

Keywords

Influenza; Kidney transplant; Vaccination

Outcome Measures

Primary Outcomes (1)

• Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection 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.

  8 months

• Comparison the evolution of antibody titres reacting in each arm.

  7 months

• Evolution of the number of memory B cells in each arm.

  7 months

• Evolution of the number of CD4+ T cells in each arm.

  7 months

• Evolution of the number of CD8+ T cells in each arm.

  7 months

Study Arms (2)

Morning injection

ACTIVE COMPARATOR

EFLUELDA influenza vaccine injection between 07:00 am and 09:00 am.

Other: Vaccine injection

Evening injection

ACTIVE COMPARATOR

EFLUELDA influenza vaccine injection between 07:00 pm and 09:00 pm.

Other: Vaccine injection

Interventions

Vaccine injection OTHER

Injection of the vaccine in renal transplant patients.

Also known as: EFLUELDA - Fluzone High-Dose Quadrivalent

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:

• Renal transplant patient;
• Follow-up at Nice University Hospital;
• Age \> 18 years;
• Indication for influenza vaccination
• Free and informed consent;
• Immunosuppressive treatment including anti-calcineurin and/or Mycophenolate Mofetil (with or without corticoids).

You may not qualify if:

• Known hypersensitivity to influenza vaccine or egg proteins;
• Influenza vaccination for the 2023-2024 season already performed;
• Current infection;
• Current acute medical condition;
• Treatment of rejection within the previous 3 months;
• Immunosuppressive therapy including CTLA4 agonist, mTOR inhibitor, complement inhibitor, anti-CD19;
• Polyvalent immunoglobulin infusion within the preceding 3 months;
• Vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French);
• Subjects not affiliated to the Social Security system.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU Nice - Hôpital Pasteur 2

Nice, Alpes-Maritimes, 06000, France

Location

MeSH Terms

Conditions

Infections; Influenza, Human

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• GOSSET Clément, MD

  CHU NICE

  PRINCIPAL INVESTIGATOR

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: October 6, 2023
• First Posted: October 18, 2023
• Study Start: October 26, 2023
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)