Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06088563
Other study ID # 23-PP-09
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 26, 2023
Est. completion date October 26, 2024

Study information

Verified date January 2024
Source Centre Hospitalier Universitaire de Nice
Contact GOSSET Clément, MD
Phone 492038632
Email gosset.c@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Immune response to influenza vaccine in kidney transplant patients


Description:

Seasonal influenza vaccination is recommended for kidney transplant patients, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. Nevertheless, injection of influenza vaccine induces a protective immune response in only 20% to 40% of patients. Today, there are no recommendations regarding the injection time of influenza vaccine in the general population or in immunocompromised patients. In this context, recent studies conducted in healthy subjects have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza, COVID-19. On this basis, we formulate the main hypothesis that the administration of influenza vaccine to kidney transplant patients would be more effective when carried out in the morning than in the evening.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 26, 2024
Est. primary completion date October 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Vaccine injection
Injection of the vaccine in renal transplant patients.

Locations

Country Name City State
France CHU Nice - Hôpital Pasteur 2 Nice Alpes-Maritimes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of seasonal influenza virus infections in each arm. Comparing the number of seasonal influenza virus infections in kidney transplant patients between a group of patients vaccinated in the morning and a group vaccinated in the evening.
The occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.
8 months
Secondary Comparison the evolution of antibody titres reacting in each arm. In kidney transplant patients, 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
Secondary Evolution of the number of memory B cells in each arm. To compare in kidney transplant patients the evolution of the number of memory B cells 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 number of memory B cells reacting with vaccine antigens will be measured by ELISPOT ;
7 months
Secondary Evolution of the number of CD4+ T cells in each arm. Comparing the evolution of CD4+ T cells reacting with vaccine antigens in kidney transplant patients 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.
The number of CD4+ T cells reacting with vaccine antigens will be measured by in vitro proliferation assay;
7 months
Secondary Evolution of the number of CD8+ T cells in each arm. Comparing the evolution of CD8+ T cells reacting with vaccine antigens in kidney transplant patients 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.
The number of CD8+ T cells reacting with vaccine antigens will be measured by in vitro proliferation assay;
7 months
See also
  Status Clinical Trial Phase
Terminated NCT05977127 - Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly Phase 2
Recruiting NCT06048406 - Effect of Health Education on Promoting Influenza Vaccination Health Literacy N/A
Completed NCT03144518 - Mood and Influenza Vaccine Response: A Feasibility Trial N/A
Completed NCT05869201 - Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine Phase 2/Phase 3
Completed NCT05160766 - Assessing Immune Response of Different COVID-19 Vaccines in Older Adults Phase 2
Recruiting NCT05222139 - Monitoring COVID-19 Vaccination Response in Fragile Populations
Enrolling by invitation NCT05028881 - COVID-19 Serology in People Living With HIV in Hong Kong
Recruiting NCT05315362 - Establishing Immunogenicity and Safety of Needle-free Intradermal Delivery of mRNA COVID-19 Vaccine Phase 2
Not yet recruiting NCT04848441 - Risk of COVID-19 Infection After Vaccination
Recruiting NCT04920357 - Immune Response to Vaccination Against Covid-19, a Follow up Study
Not yet recruiting NCT03880669 - The 6-in-1 Vaccine Study Phase 4
Recruiting NCT05898464 - Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV Phase 4
Not yet recruiting NCT05856396 - Maternal Determinants of Infant Immunity to Pertussis Phase 4
Recruiting NCT05658614 - Anti-Schistosomiasis Sm14-vaccine in Senegal Phase 2
Completed NCT05457894 - Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women Phase 3
Completed NCT05470582 - Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old Phase 3
Recruiting NCT05160428 - Post Covid-19 Vaccination Development or Flare of ARD
Recruiting NCT05705180 - The Influence of Trained Immunity in COVID-19 Vaccinated Individuals
Recruiting NCT04970836 - The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort N/A