tetano
Editor, Senior Moderator
BMJ Open
. 2024 Jul 1;14(6):e084808.
doi: 10.1136/bmjopen-2024-084808. 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[SUP] 1 2 [/SUP], Mads Kjolby[SUP] 3 4 5 [/SUP], Astrid Johannesson Hjelholt[SUP] 3 6 [/SUP], Mette Madsen[SUP] 7 8 [/SUP], Ann-Margrethe Rønholt Christensen[SUP] 7 8 [/SUP], Ditte Adolfsen[SUP] 9 [/SUP], Jesper Sand Hjelle[SUP] 3 10 [/SUP], Britta Kremke[SUP] 11 [/SUP], Henrik Støvring[SUP] 3 4 [/SUP], Niels Jessen[SUP] 3 4 [/SUP], Esben Thyssen Vestergaard[SUP] 2 12 [/SUP], Kurt Kristensen[SUP] 3 2 [/SUP], Ole Frobert[SUP] 4 13 [/SUP]
Affiliations
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.
Keywords: Clinical Trial; Paediatric endocrinology; Vaccination.
. 2024 Jul 1;14(6):e084808.
doi: 10.1136/bmjopen-2024-084808. 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[SUP] 1 2 [/SUP], Mads Kjolby[SUP] 3 4 5 [/SUP], Astrid Johannesson Hjelholt[SUP] 3 6 [/SUP], Mette Madsen[SUP] 7 8 [/SUP], Ann-Margrethe Rønholt Christensen[SUP] 7 8 [/SUP], Ditte Adolfsen[SUP] 9 [/SUP], Jesper Sand Hjelle[SUP] 3 10 [/SUP], Britta Kremke[SUP] 11 [/SUP], Henrik Støvring[SUP] 3 4 [/SUP], Niels Jessen[SUP] 3 4 [/SUP], Esben Thyssen Vestergaard[SUP] 2 12 [/SUP], Kurt Kristensen[SUP] 3 2 [/SUP], Ole Frobert[SUP] 4 13 [/SUP]
Affiliations
- PMID: 38950997
- DOI: 10.1136/bmjopen-2024-084808
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.
Keywords: Clinical Trial; Paediatric endocrinology; Vaccination.