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

NCT06252051 | Completed Phase 4 DMC

• 1 other identifier: S3-202401.01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Vaccine Reaction; Diabetes Mellitus; Chronic Kidney Diseases

Keywords

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

Outcome Measures

Primary Outcomes (2)

• ILI Morbidity

  Determined by the time from treatment to 6 months after

  6 months

• Immunogenicity

  Determine the changes in titers over time using the hemagglutination (HA) method at the 1st, 3rd, and 6th months after vaccination.

  6 months

Secondary Outcomes (1)

• Inflammatory interleukin measurements

  6 months

Study Arms (1)

Trivalent Vaccine

EXPERIMENTAL

Drug: Trivalent Influenza Vaccine

Interventions

Trivalent Influenza Vaccine DRUG

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.

Trivalent Vaccine

Eligibility Criteria

• Age: 40 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• Biofarma: collaborator
• Universiti Sains Malaysia: collaborator

Study Sites (1)

AMC Hospital

Bandung, West Java, Indonesia

Location

MeSH Terms

Conditions

Influenza, Human; Diabetes Mellitus; Renal Insufficiency, Chronic

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Nur Atik, MD

  Universitas Padjadjaran

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 9, 2024
• Study Start: January 5, 2021
• Primary Completion: March 31, 2022
• Study Completion: August 31, 2022
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)