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Effectiveness of Trivalent Influenza Vaccine (TIV) in Type 2 Diabetes Mellitus (T2DM) Patients With and Without Complications of Chronic Kidney Disease (CKD)

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06252051
Enrollment
76
Registered
2024-02-09
Start date
2021-01-05
Completion date
2022-08-31
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Diabetes Mellitus, Influenza, Vaccine Reaction

Keywords

Immunogenicity, Trivalent Influenza Vaccine, Diabetes Mellitus, Chronic Kidney Diseases

Brief summary

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.

Detailed description

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. The 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.

Interventions

DRUGTrivalent 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.

Sponsors

Biofarma
CollaboratorINDUSTRY
Universiti Sains Malaysia
CollaboratorOTHER
Universitas Padjadjaran
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
ILI Morbidity6 monthsDetermined by the time from treatment to 6 months after
Immunogenicity6 monthsDetermine the changes in titers over time using the hemagglutination (HA) method at the 1st, 3rd, and 6th months after vaccination.

Secondary

MeasureTime frameDescription
Inflammatory interleukin measurements6 monthsInflammatory analysis will be performed in the 1st, 3rd, and 6th months.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026