Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-26 @ 4:56 PM
Study NCT ID:
NCT06252051
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2024-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Trivalent Influenza Vaccine (TIV) in Type 2 Diabetes Mellitus (T2DM) Patients With and Without Complications of Chronic Kidney Disease (CKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2024-01-28', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ILI Morbidity', 'timeFrame': '6 months', 'description': 'Determined by the time from treatment to 6 months after'}, {'measure': 'Immunogenicity', 'timeFrame': '6 months', 'description': 'Determine the changes in titers over time using the hemagglutination (HA) method at the 1st, 3rd, and 6th months after vaccination.'}], 'secondaryOutcomes': [{'measure': 'Inflammatory interleukin measurements', 'timeFrame': '6 months', 'description': 'Inflammatory analysis will be performed in the 1st, 3rd, and 6th months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunogenicity', 'Trivalent Influenza Vaccine', 'Diabetes Mellitus', 'Chronic Kidney Diseases'], 'conditions': ['Influenza', 'Vaccine Reaction', 'Diabetes Mellitus', 'Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'This study assesses the effectiveness of the seasonal flu vaccine in individuals with Type 2 Diabetes Mellitus (T2DM) with and without Chronic Kidney Disease (CKD), as well as in healthy individuals. Additionally, the study investigates the dynamics of cytokines, specifically IL-2 and IL-6, in the three groups following influenza vaccination. The findings from these studies will contribute to our understanding of the safety and efficacy of the influenza vaccine in T2DM and T2DM-CKD, shedding light on inflammation changes and informing future research on mitigation strategies.', 'detailedDescription': "The aim of this study is to assess the effectiveness of the influenza vaccine in the T2DM group, T2DM-CKD group, and healthy individuals without DM or CKD as a comparison. Patients with T2DM are characterized by low-grade inflammation, making them susceptible to infections, particularly influenza, leading to increased ICU admissions and mortality rates. Diabetes mellitus is also a major cause of declining kidney function, with complications known as diabetic kidney disease, ultimately progressing to chronic kidney disease, the most common cause of patients undergoing haemodialysis. The vulnerability to influenza infections prompts the recommendation for influenza vaccination in T2DM patients. Chronic kidney disease is a complication of diabetes that becomes intriguing to study regarding the effectiveness of the influenza vaccine in this group. Safety monitoring for all three groups is conducted for one month post-vaccination, assessing local symptoms such as redness at the injection site, pain, and systemic symptoms like fever, diarrhoea, weakness, or fatigue. Information related to influenza vaccine effectiveness is obtained by monitoring flu-like syndrome symptoms at months 1, 3, and 6. The researchers also examine interleukin levels, specifically IL-2 and IL-6, before and after vaccination for one month. This examination aims to understand the dynamic changes in both interleukins since IL-2 plays a role in protecting DM patients from influenza virus infections, particularly in preventing secondary infections like pneumonia.\n\nThe researcher's hypothesis is that T2DM-CKD patients will exhibit lower antibody responses compared to uncomplicated T2DM patients, and antibody titters against the influenza virus will decline after six months. This study will contribute valuable insights into the frequency of influenza vaccine administration in T2DM and T2DM-CKD groups, potentially reducing morbidity and mortality rates."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1 (T2DM)\n\n* Individuals with Type 2 Diabetes Mellitus (T2DM)\n* Age range: 40-59 years\n\nGroup 2 (T2DM-CKD):\n\n* Individuals with Type 2 Diabetes Mellitus (T2DM)\n* Age range: 40-59 years\n* eGFR (ml/min/1.73 m2) \\>15\n* eGFR (ml/min/1.73 m2) \\<89\n* Proteinuria\n\nGroup 3 (Healthy Person) :\n\n* Individuals without Type 2 Diabetes Mellitus (T2DM)\n* Age range: 40-59 years\n\nExclusion Criteria:\n\n* Incomplete medical records\n* CKD Stage 5\n* Currently pregnant\n* Currently on long-term steroid use\n* Received influenza vaccine in the last year\n* Diagnosed with malignancy\n* Autoimmune disease\n* History of allergy to chicken eggs or vaccine constituents\n* High fever, seizures, or acute infection\n* History of COVID infection based on PCR testing with the last PCR result negative \\<14 days\n* History of COVID-19 vaccination \\<14 days from the last vaccine administration'}, 'identificationModule': {'nctId': 'NCT06252051', 'briefTitle': 'Effectiveness of Trivalent Influenza Vaccine (TIV) in Type 2 Diabetes Mellitus (T2DM) Patients With and Without Complications of Chronic Kidney Disease (CKD)', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Padjadjaran'}, 'officialTitle': 'Effectiveness of Trivalent Influenza Vaccine (TIV) in Type 2 Diabetes Mellitus (T2DM) Patients With and Without Complications of Chronic Kidney Disease (CKD): A Clinical Observational Study on Antibody Titers and Dynamic Changes in IL-2 and IL-6 Cytokines', 'orgStudyIdInfo': {'id': 'S3-202401.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trivalent Vaccine', 'interventionNames': ['Drug: Trivalent Influenza Vaccine']}], 'interventions': [{'name': 'Trivalent Influenza Vaccine', 'type': 'DRUG', 'description': 'We divided the participants into three groups: one comprising healthy individuals, another consisting of those with type 2 diabetes mellitus (T2DM), and the last group comprising individuals with T2DM and chronic kidney disease (CKD). All participants will receive a trivalent influenza vaccine, and various parameters will be observed.', 'armGroupLabels': ['Trivalent Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bandung', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'AMC Hospital', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}], 'overallOfficials': [{'name': 'Nur Atik, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitas Padjadjaran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Padjadjaran', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biofarma', 'class': 'INDUSTRY'}, {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}