Effectiveness of Trivalent Influenza Vaccine (TIV) in Type 2 Diabetes Mellitus (T2DM) Patients With and Without Complications of Chronic Kidney Disease (CKD)
Condition: Influenza; Vaccine Reaction; Diabetes Mellitus; Chronic Kidney Diseases
MeSH terms: Influenza, Human; Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Trivalent Influenza Vaccine
Intervention type(s): Drug
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity; Trivalent Influenza Vaccine; Diabetes Mellitus; Chronic Kidney Diseases