GPPAD-05-AVAnT1A
Research type
Research Study
Full title
Anti-viral action against Type 1 diabetes autoimmunity
IRAS ID
1009668
Contact name
Catherine Owen
Contact email
Sponsor organisation
Klinikum rechts der Isar of Technical University Munich
Eudract number
2023-507348-35
ISRCTN Number
ISRCTN82491599
Research summary
This study is a randomized, controlled, multicentre, multinational trial to assess whether vaccination against COVID-19 (SARS-CoV-2) from age 6 months (with 3 doses of BioNTech/Pfizer Comirnaty 3mcg) in infants with an elevated genetic risk (>10%) of type 1 diabetes (T1D) reduces the development of islet autoantibodies.
The incidence of T1D increased sharply during the COVID pandemic. Islet autoantibodies in the blood are the first signs of a child developing T1D. Research has shown that early childhood infection with the SARS-CoV-2 virus more than doubles the risk of developing islet autoantibodies. This virus can enter and infect the islet cells of the pancreas, so it is plausible this may increase susceptibility. The main objective of the study is to investigate whether vaccination against COVID-19, at the age of 6 months, is superior to placebo in preventing the development of islet autoantibodies in children at increased genetic risk of T1D.
Participants with a high genetic risk of developing T1D (identified from the currently running INGRID-2 trial) will be enrolled at 3 months of age and will receive vaccination in 3 doses, between 6 and 11 months of age. 50% of recruited patients will receive the SARS-CoV-2 vaccine and 50% placebo vaccination (normal saline). Ongoing monitoring visits will occur post vaccination for between 2-1/2 to 6 years, depending on when recruited into the study. Blood and stool samples will be collected at each visit and participants will collect weekly saliva samples and monthly stool samples at home for infection surveillance. They will also complete a fortnightly questionnaires for the first 24 months around infections and twice during the study around physical and mental health.
This study is funded by the Leona M and Harry B Helmsley Charitable trust and plans to include 9 clinical study sites, distributed around 5 European countries. The aim is to recruit 2,252 infants.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0112
Date of REC Opinion
24 Jun 2024
REC opinion
Further Information Favourable Opinion