AVAnT1A STUDY:

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What is the AVAnT1A Study?

The AVAnT1A Study - short for "Antiviral Action against Type 1 diabetes Autoimmunity" - examines whether vaccination against COVID-19 at the age of six months can prevent the development of islet autoantibodies in babies at increased genetic risk of developing type 1 diabetes, thus reducing their risk of developing the condition. In addition, the researchers want to monitor in saliva and stool samples which viruses the children had contact with. This allows the researchers to clarify further connections between type 1 diabetes and viral infections in early childhood.

What is the scientific background for this study?

In large-scale, long-term studies, researchers at Helmholtz Munich have identified viral infections in early childhood as a crucial environmental factor for the development of type 1 diabetes. During the COVID-19 pandemic, GPPAD researchers made another important observation: after contracting a SARS-CoV-2 infection, children with an increased risk for type 1 diabetes were more likely to develop islet autoantibodies. The AVAnT1A Study aims to further investigate this relationship.

What is the course of the study?

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. 

How can my child participate?

Children with an increased genetic risk for developing type 1 diabetes are invited to participate in the AVAnT1A Study. Their increased risk is detected within the newborn screening called Freder1k, which for Germany is offered in Bavaria, Lower Saxony, Saxony, and Thuringia. Parents can test their newborns either directly at the birth clinic or in the pediatrician's office until six weeks of age. A drop of blood from the umbilical cord or heel is sufficient for this test. Additionally, relatives of people with type 1 diabetes can participate all over Germany.

 

Families can participate in the AVAnT1A Study if...

…their child is not older than three months.

…their child has an increased risk to develop type 1 diabetes. The risk can be determined within the first six weeks of life.

Further information on participation

Freder1k and AVANT1A Information Flyer

 

If you're interested in learning more, feel free to contact us. Our study coordinator is available to answer all your questions.

  • Phone: +49 89 3187-14576
  • E-mail: alexandra.kaessl@helmholtz-munich.de
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