Phase 4 Study of COVID-19 Vaccination to Prevent Type 1 Diabetes Autoimmunity in Infants at High Genetic Risk

What this Trial Is About

Researchers are studying whether giving COVID-19 vaccines to young children with a higher genetic risk of developing type 1 diabetes can lower the chance of developing this condition or related autoantibodies. This phase 4 trial involves children identified through genetic risk screening. The study aims to see if vaccination starting from 6 months of age can reduce the occurrence of islet autoantibodies, type 1 diabetes, and celiac disease-related autoantibodies during childhood. Children enrolled between 3 and 4 months old will be randomly assigned to receive either the Comirnaty 3 microgram Omicron XBB.1.5 vaccine or updated variant vaccines or a placebo saline solution. They will receive three intramuscular doses starting at age 6 to 7 months, with the second dose given 3 to 6 weeks after the first, and the third dose at least 8 weeks after the second, around 8.5 to 11 months of age. Dose adjustments may be made if the child develops COVID-19 infection. During the study, participants will be monitored for up to 6 years to track the presence of persistent islet autoantibodies, type 1 diabetes diagnosis, and celiac disease-related autoantibodies. Parent consent is required before enrollment, and children will be regularly assessed to evaluate the vaccines impact on these outcomes. The study will also observe safety and adherence throughout the follow-up period.

Anti-viral Action Against Type 1 Diabetes Autoimmunity