A new trial will investigate whether vaccination against COVID-19 in the first year of life can protect children who have an increased genetic risk of developing type 1 diabetes.
In people with type 1 diabetes, the immune system produces proteins (auto-antibodies) that destroy the cells in the pancreas that produce insulin (islet cells).
Vital role of insulin
Insulin plays a vital role in controlling the levels of glucose (sugar) in the body. The exact cause of what makes the immune system destroy islet cells is unknown but viral infections are known triggers in some cases.
During the COVID-19 pandemic, researchers found that children who had the virus before the age of 18 months were five times more likely to develop these autoantibodies, indicating the beginning of type 1 diabetes (pre-diabetes).
The AVAnT1A study (AntiViral Action Against Type 1 Autoimmunity) will assess whether vaccination against covid at the age of six months can prevent these autoantibodies from developing.
The vaccine is well-tolerated and approved for this age group. Participants will be randomly assigned to two groups, one will receive the COVID-19 vaccine, and the other will receive a placebo (dummy) injection that doesn’t contain any vaccine.
The study is double-blinded, meaning neither the parent/carer or clinical team know which group the child is in.
Lifelong, challenging condition
Dr Kate Owen, consultant paediatric endocrinologist at Newcastle Hospitals’ Great North Children’s Hospital, is leading the trial in Newcastle. She said:
“There’s no cure for type 1 diabetes because it is caused by a problem with the immune system. It requires lifelong management which can be challenging and take time to get used to.
“Clinical trials such as AVAnT1A are taking us a step closer to understanding what triggers the immune system to destroy insulin-producing cells.
“We hope to one day prevent type 1 diabetes from developing and reduce the number of people living with the condition.”
31-year-old Leona Kovacs had daughter Hollie-mae in July 2024. Shortly after giving birth, Leona was asked if she wanted Hollie-mae to take part in a Newcastle-led trial called INGR1D2.
INGR1D2, which has now recruited 25,000 babies across eight hospitals in the region, tests for type 1 diabetes on blood taken as part of the routine heel prick test.
Results of the test confirmed that Hollie-mae had an increased risk of developing the condition. Hollie-mae is now taking part in the AVAnT1A trial.
Healthy future
Leona said:
“I was told about the study just after Hollie-mae was born. It was really simple to take part and I was keen to know if my daughter was at risk of type 1 diabetes.
“I was quite surprised with the result because there’s no history of the condition in my family, but I’d much rather know now than find out when Hollie-mae is older.
“Anything I can do to make sure Hollie-mae has a healthy future is really important, so I was happy for her to take part in the AVAnT1A trial.”
INGR1D2 is one of the largest research studies ever conducted at Newcastle Hospitals; so far 25,000 mothers and babies have been recruited across the North East and North Cumbria. Over 300 babies have been identified as being at increased risk of type 1 diabetes to date.
AVAnT1A is the third international trial, run by the Global Platform for the Prevention of Autoimmune Diabetes (GPPAD), supported by the Helmsley Charitable Trust.
Newcastle University and Newcastle Hospitals lead GPPAD in the UK.
INGR1D2 is second largest research study ever conducted at Newcastle Hospitals; so far 25,000 mothers and babies have been recruited across the North East and North Cumbria.
AVAnT1A is the third international trial, run by the Global Platform for the Prevention of Autoimmune Diabetes, supported by the Helmsley Charitable Trust.
For more information about INGR1D2 and AVAnT1A, including local contact details, please visit this website.
Further information
- Over 300 babies have been identified as being at increased risk of type 1 diabetes to date
- Newcastle University and Newcastle Hospitals lead the research platform in the UK.
- AVAnT1A and INGR1D2 are part of the work of the Global Platform for the Prevention of Autoimmune Diabetes (GPPAD), a network which brings together research institutions and hospitals in Europe.
- AVAnT1A is GPPAD’s third study aimed at developing preventative measures for type 1 diabetes. More information can be found on GPPAD’s website.
The study is supported by funding from The Leona M. and Harry B. Helmsley Charitable Trust.
