RecruitingPHASE4INTERVENTIONAL

Anti-viral Action Against Type 1 Diabetes Autoimmunity

This research, called AVAnT1A, is a large study looking into whether getting a COVID-19 vaccine can help prevent type 1 diabetes in very young children. We know that some children are more likely to develop type 1 diabetes because of their genes. This study will involve over 2,200 children, starting when they are 6 months old. Half will receive the COVID-19 vaccine (Comirnaty) and half will receive a dummy shot (placebo). Scientists want to see if the vaccine helps lower the number of children who develop early signs of type 1 diabetes or the condition itself by carefully monitoring them over time. The study also explores if the vaccine might affect the development of coeliac disease.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Technical University of Munich

Enrolment target

2,252

Start

08 May 2024

Estimated completion

01 Oct 2027

Diabetes Mellitus, Type 1

What is this study about?

You might be wondering what this study, called AVAnT1A, is all about. It's designed to explore a really important question: can a common vaccine, like the COVID-19 vaccine, play a role in preventing type 1 diabetes in children? Scientists believe that some viral infections might be linked to the development of type 1 diabetes. Because of this, they are looking into whether vaccinating children against COVID-19 could help reduce their risk.

This study is for children who have been identified as having a higher genetic risk of developing type 1 diabetes. This doesn't mean they will definitely get it, but it means their genes make them more likely to. By giving some of these children a COVID-19 vaccine and others a placebo (a dummy injection that looks like the vaccine but contains no active medicine), researchers can carefully compare what happens in both groups over time. This helps them understand if the vaccine has any protective effect.

The main goal is to see if the children who received the vaccine are less likely to develop certain early warning signs of type 1 diabetes (called 'islet autoantibodies') or type 1 diabetes itself. They're also checking if it affects the development of coeliac disease-related markers. This is a very thorough study involving many different research centres and countries, and it's being done to find out more about how to protect children from type 1 diabetes in the future.

Key takeaways

This study investigates if a COVID-19 vaccine can prevent type 1 diabetes in at-risk children.
It involves children between 6 and 7 months old, receiving either the vaccine or a placebo.
The study monitors for early signs of type 1 diabetes and coeliac disease.
Participation requires a genetic risk factor for type 1 diabetes.
Results could help develop new prevention strategies for type 1 diabetes.

Who may be eligible?

To join this study, children need to be between 3 and 4 months old when they first enrol. They must also have a higher genetic risk of developing type 1 diabetes. This risk is found through a blood test that looks at specific genes.

Your child won't be able to join if they have had a bad reaction to vaccines before, or if they have certain serious health conditions, especially those that affect their immune system. Also, if they have diabetes already or are taking other experimental medicines, they wouldn't be able to take part.

It's very important that your child (and your family) can complete the study as planned, so if there's a good chance you'll be moving away and won't be able to attend follow-up appointments, your child might not be suitable for the study.

Quick self-check

Is my child between 3 and 4 months old right now?
Has my child been identified as having a higher genetic risk for type 1 diabetes?
Does my child have any serious illnesses or immune problems?
Has my child ever had a severe allergic reaction to a vaccine?
Are we likely to stay in the area for the duration of the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part, the journey starts when they are between 3 and 4 months old, when you'll give your permission (consent) for them to join. The actual study treatments (either the COVID-19 vaccine or the placebo) will be given when your child is between 6 and 7 months old. Your child will be randomly assigned to one of these groups, meaning it's like a coin toss – neither you nor the doctors can choose which one they get.

After this, your child will have regular check-ups and assessments. These visits will involve monitoring their health and checking for any signs related to type 1 diabetes. The study will continue for a number of years to see how the children develop. The total duration of participation isn't specified here, but clinical trials usually involve ongoing follow-up for several years.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be that if the vaccine does protect against type 1 diabetes, your child might gain that protection. However, we don't know for sure if it will work, and some children will receive a placebo. Potential risks are similar to those of standard vaccinations, such as a sore arm, fever, or feeling unwell for a short time. There could also be other, unexpected side effects. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (9)

Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria
Vienna, Austria· Not yet recruiting
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven
Leuven, Belgium· Recruiting
Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich
Munich, Germany· Recruiting
AUF DER BULT, Kinder- und Jugendkrankenhaus
Hanover, Germany· Recruiting
Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden
Dresden, Germany· Recruiting
Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS
Malmö, Sweden· Recruiting
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom· Not yet recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom· Not yet recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom· Recruiting

Common questions

What is the purpose of this study?

The study aims to see if a COVID-19 vaccine can help prevent type 1 diabetes in young children who are at a higher genetic risk of developing it.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real vaccine but doesn't contain any active medicine. It helps researchers compare the effects accurately.

Will my child definitely get the vaccine?

No, your child will be randomly assigned to either receive the COVID-19 vaccine or the placebo. You won't know which one they receive until the end of the study.

How will I know if my child is at 'high genetic risk'?

Your child's genetic risk would have been determined through an earlier screening study that looked at specific genes linked to type 1 diabetes.

Can I take my child out of the study at any time?

Yes, you are free to withdraw your child from the study at any point, and this won't affect their future medical care.

How to find out more

Anette-G. Ziegler, Prof. Dr.

anettegabriele.ziegler@helmholtz-munich.de +49-89-3187 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.