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Immune response to influenza vaccine in patients with chronic renal insufficiency.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning injection | Active Comparator | VAXIGRIPTETRA influenza vaccine injection between 07:00 am and 11:00 am. |
|
| Evening injection | Active Comparator | VAXIGRIPTETRA influenza vaccine injection between 05:00 pm and 09:00 pm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine injection | Other | Injection of the vaccine in chronic renal insufficiency patients. |
|
| 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 |
| 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 |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GOSSET Clément, MD | Contact | 492038632 | +33 | gosset.c@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| GOSSET Clément, MD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nice - HĂ´pital Pasteur 2 | Recruiting | Nice | Alpes-Maritimes | 06000 | France |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D007251 | Influenza, Human |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 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 |
| 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 |
| 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 |
| D012140 | Respiratory Tract Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |