CHU Nice - Hôpital Pasteur 2
Nice, Alpes-Maritimes, 06000, France
Location status: Recruiting
NCT Number: NCT06907667
Immune response to influenza vaccine in patients with chronic renal insufficiency.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Nice, Alpes-Maritimes, 06000, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of the vaccine in chronic renal insufficiency patients.
Other names: VAXIGRIPTETRA - quadrivalent inactivated influenza vaccine.
Time frame: 7 months
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.
Time frame: 7 months
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.
Time frame: 12 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.
Time frame: 7 months
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 ;
Time frame: 7 months
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
Time frame: 7 months
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.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nice
Other
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2
Acronym: CHRONOVAX2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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