Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT06907667
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 735}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-03-26', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine in each arm.', 'timeFrame': '7 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of seasonal influenza virus infections in each arm at 4 weeks', 'timeFrame': '7 months', 'description': '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.\n\nThe occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.'}, {'measure': 'Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months', 'timeFrame': '12 months', 'description': '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.\n\nThe occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.'}, {'measure': 'Antibody titers reacting in each arm', 'timeFrame': '7 months', 'description': '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.\n\nThe titer of antibodies reacting with vaccine antigens is measured by ELISA ;'}, {'measure': 'Number of anti-vaccine antibodies inhibiting hemmagglutination', 'timeFrame': '7 months', 'description': '4 weeks after influenza vaccine injection, compare hemmagglutination-inhibiting anti-vaccine antibody titer in CKD patients vaccinated in the morning and evening.\n\nThe titer of hemagglutination-inhibiting anti-vaccine antibodies will be determined by hemagglutination inhibition test'}, {'measure': 'Number of neutralizing anti-vaccine antibodies', 'timeFrame': '7 months', 'description': 'To compare, 4 weeks after influenza vaccine injection, the titer of neutralizing antivaccine antibodies in CKD patients vaccinated in the morning and evening.\n\nThe titer of neutralizing anti-vaccine antibodies will be determined by a pseudo-neutralization test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza', 'chronic renal insufficiency', 'Vaccination'], 'conditions': ['Vaccination; Infection']}, 'descriptionModule': {'briefSummary': 'Immune response to influenza vaccine in patients with chronic renal insufficiency.', 'detailedDescription': '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.\n\nThere are currently no recommendations concerning the timing of influenza vaccine in the general population or in immunocompromised patients.\n\nIn 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.\n\nOn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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;\n* Age ≥ 18 years;\n* Indication for influenza vaccination;\n* Express free and informed consent.\n\nExclusion Criteria:\n\n* Known hypersensitivity to influenza vaccine or egg proteins;\n* Previous influenza vaccination for the current season;\n* Current infection;\n* Current acute illness;\n* Treatments with a major impact on vaccine response:\n* Treatment of rejection within the previous 3 months;\n* Renal transplantation with induction performed within the previous 6 months;\n* Immunosuppressive treatment including CTLA4 agonist, complement inhibitor, anti-CD20;\n* Treatments that may distort the serological response: Polyvalent immunoglobulin infusion within the preceding 3 months;\n* Vulnerable persons (minors, adults under guardianship or trusteeship, persons deprived of their liberty, persons unable to speak French);\n* Subjects not affiliated to Social Security.'}, 'identificationModule': {'nctId': 'NCT06907667', 'acronym': 'CHRONOVAX2', 'briefTitle': 'Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2', 'orgStudyIdInfo': {'id': '23-API-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Morning injection', 'description': 'VAXIGRIPTETRA influenza vaccine injection between 07:00 am and 11:00 am.', 'interventionNames': ['Other: Vaccine injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Evening injection', 'description': 'VAXIGRIPTETRA influenza vaccine injection between 05:00 pm and 09:00 pm.', 'interventionNames': ['Other: Vaccine injection']}], 'interventions': [{'name': 'Vaccine injection', 'type': 'OTHER', 'otherNames': ['VAXIGRIPTETRA - quadrivalent inactivated influenza vaccine.'], 'description': 'Injection of the vaccine in chronic renal insufficiency patients.', 'armGroupLabels': ['Evening injection', 'Morning injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'Alpes-Maritimes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clément GOSSET, MD', 'role': 'CONTACT', 'email': 'gosset.c@chu-nice.fr', 'phone': '492037918', 'phoneExt': '+33'}], 'facility': 'CHU Nice - Hôpital Pasteur 2', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'GOSSET Clément, MD', 'role': 'CONTACT', 'email': 'gosset.c@chu-nice.fr', 'phone': '492038632', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'GOSSET Clément, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU NICE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}