Clinical trial

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

NCT06252051

Name

S3-202401.01

Description

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.

Trial arms

Trial start

2021-01-05

Estimated PCD

2022-03-31

Trial end

2022-08-31

Status

Completed

Phase

Early phase I

Treatment

Trivalent Influenza Vaccine

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.

Arms:

Trivalent Vaccine

Size

Primary endpoint

ILI Morbidity

6 months

Immunogenicity

6 months

Eligibility criteria

Inclusion Criteria: Group 1 (T2DM) * Individuals with Type 2 Diabetes Mellitus (T2DM) * Age range: 40-59 years Group 2 (T2DM-CKD): * Individuals with Type 2 Diabetes Mellitus (T2DM) * Age range: 40-59 years * eGFR (ml/min/1.73 m2) \>15 * eGFR (ml/min/1.73 m2) \<89 * Proteinuria Group 3 (Healthy Person) : * Individuals without Type 2 Diabetes Mellitus (T2DM) * Age range: 40-59 years Exclusion Criteria: * Incomplete medical records * CKD Stage 5 * Currently pregnant * Currently on long-term steroid use * Received influenza vaccine in the last year * Diagnosed with malignancy * Autoimmune disease * History of allergy to chicken eggs or vaccine constituents * High fever, seizures, or acute infection * History of COVID infection based on PCR testing with the last PCR result negative \<14 days * History of COVID-19 vaccination \<14 days from the last vaccine administration

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 76, 'type': 'ACTUAL'}}

Updated at

2024-02-09

1 organization

1 product

4 indications

Organization

Universitas Padjadjaran

Product

Trivalent Influenza Vaccine

Indication

Influenza

Indication

Adverse Reaction to Immunization

Indication

Diabetes Mellitus

Indication

Chronic Kidney Disease