Vaccination against SARS-CoV-2

Participating children receive three vaccines: the first by the age of six months, the second three to six weeks later, and the third after another eight weeks have passed. The COVID-19 vaccine used is safe and approved for children aged six months and older.

AVAnT1A has a randomized, placebo-controlled study design. This means that participating children are randomly assigned to two groups beforehand. The intervention group will receive the vaccine against SARS-CoV-2, the control group will receive a placebo injection without active ingredients. Additionally, the study is double-blinded, so the researchers, the study personnel, and the families will not know which group a child belongs to until the study is completed.

Collection of Saliva and Stool samples

Since many infections in young children occur almost without symptoms, participating families are asked to collect saliva (weekly) and stool samples (monthly) from their children at regular intervals. From these samples, researchers can identify which viruses the children had contact with.

Regular Physical Examination

During the study, the families are invited for regular physical examinations including the determination of height and weight as well as blood draws. In the first phase of the study, a physical examination is conducted every three months, then every six months and after the third birthday once per year. Children are invited maximum up until their sixth birthday. Our study team can answer all questions regarding diabetes and the child's well-being during the visit. If a child shows initial signs of the autoimmune disease, this can be detected early in the disease progression, ensuring families access to optimal support and information to support their child. All examinations during the study program are free of charge.