INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED): a study protocol for a randomised, double-blind, placebo-controlled clinical trial in children and adolescents with recent-onset type 1 diabetes

Ida Borreby Pedersen*, Mads Kjolby, Astrid Johannesson Hjelholt, Mette Madsen, Ann-Margrethe Rønholt Christensen, Ditte Adolfsen, Jesper Sand Hjelle, Britta Kremke, Henrik Støvring, Niels Jessen, Esben Thyssen Vestergaard, Kurt Kristensen, Ole Frobert

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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Abstract

INTRODUCTION: Children and adolescents with recent-onset type 1 diabetes (T1D) commonly maintain a certain level of insulin production during the remission phase, which can last months to years. Preserving β-cell function can reduce T1D complications and improve glycaemic control. Influenza vaccination has pleiotropic effects and administration of the vaccine during the early phases of T1D may offer β-cell protection. This study aims to assess the effect of influenza vaccination on preserving β-cell function in children and adolescents with recent-onset T1D.

METHODS AND ANALYSIS: The INfluenza VaccInation To mitigate typE 1 Diabetes trial is a randomised, double-blind, placebo-controlled, multicentre trial in paediatric patients with recent-onset T1D aged 7-17 years. 100 participants will be randomised in a 1:1 ratio to receive either a standard inactivated quadrivalent influenza vaccine or a placebo within 14 days of diagnosis. The primary outcome is a difference in mean change (from baseline to 12 months) in C-peptide level between groups during a 2-hour mixed-meal tolerance test. Secondary outcomes include mean change (from baseline to 6 months) in C-peptide levels, haemoglobin A1c, ambulatory glucose profiles and insulin requirements. Exploratory outcomes are diabetes-related autoantibodies, inflammatory markers and serum haemagglutinin inhibition antibody titres against the influenza viruses. The current treatment for T1D is largely symptomatic, relying on insulin administration. There is a pressing need for novel pharmacological approaches aimed at modulating the immune system to preserve residual β-cell function. Existing immunotherapies are cost-prohibitive and associated with multiple side effects, whereas influenza vaccination is inexpensive and generally well tolerated. A positive outcome of this study holds potential for immediate implementation into standard care for children and adolescents with recent-onset T1D and may guide future research on immune modulation in T1D.

ETHICS AND DISSEMINATION: Ethical approval was obtained from Danish Health Authorities prior to participant enrollment. The trial results will be submitted to a peer-reviewed journal.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT05585983 and EudraCT Number 2022-500906-17-01.

Original languageEnglish
Article numbere084808
JournalBMJ Open
Volume14
Issue number6
Number of pages9
ISSN2044-6055
DOIs
Publication statusPublished - 1 Jul 2024

Bibliographical note

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords

  • Adolescent
  • Blood Glucose/metabolism
  • C-Peptide/blood
  • Child
  • Diabetes Mellitus, Type 1/immunology
  • Double-Blind Method
  • Female
  • Glycated Hemoglobin/metabolism
  • Humans
  • Influenza Vaccines/administration & dosage
  • Influenza, Human/prevention & control
  • Insulin
  • Insulin-Secreting Cells/immunology
  • Male
  • Randomized Controlled Trials as Topic
  • Vaccination
  • Clinical Trial
  • Paediatric endocrinology

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