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

Universitas Padjadjaran

Status and phase

Completed

Phase 4

Conditions

Chronic Kidney Diseases

Influenza

Diabetes Mellitus

Vaccine Reaction

Treatments

Drug: Trivalent Influenza Vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06252051

S3-202401.01

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

All

Ages

40 to 49 years old

Volunteers

Accepts Healthy Volunteers

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