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Study on the Effect of Raxtozinameran Vaccine in Reducing Type 1 Diabetes Risk in Children with High Genetic Susceptibility

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on children who have a higher genetic risk of developing Type 1 Diabetes, a condition where the body's immune system attacks the cells in the pancreas that produce insulin. The study aims to see if vaccinating these children against COVID-19 from the age of 6 months can reduce the chances of developing islet autoantibodies, which are markers that indicate the immune system is attacking the pancreas, or Type 1 Diabetes itself during childhood.

The treatment being studied is the Comirnaty Omicron XBB.1.5 COVID-19 mRNA Vaccine, which is a type of vaccine that uses a small piece of genetic material called mRNA to help the body recognize and fight the virus that causes COVID-19. This vaccine is given as an injection. Some participants in the study will receive this vaccine, while others will receive a 0.9% Sodium Chloride solution, which is a simple saline solution used as a placebo.

The study will follow the children over time to see if the vaccine helps in reducing the development of islet autoantibodies or Type 1 Diabetes. The main goal is to measure the time it takes for these conditions to develop after the children are randomly assigned to receive either the vaccine or the placebo. The study will continue until 2029, allowing researchers to gather enough information to understand the vaccine's impact on preventing Type 1 Diabetes in children with a high genetic risk.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, the child will have an initial visit. During this visit, the child's eligibility will be confirmed based on age and genetic risk factors for type 1 diabetes.
The custodial parent(s) will need to provide written informed consent for the child to participate in the study.
Step 2
Vaccination
The child will receive the Comirnaty Omicron XBB.1.5 vaccine, which is a COVID-19 mRNA vaccine. The vaccine is administered as an injection.
The dosage for the vaccine is 3 micrograms per dose. The frequency and duration of administration will be determined by the study protocol.
Step 3
Follow-up visits
The child will have regular follow-up visits to monitor their health and the development of any islet autoantibodies or type 1 diabetes.
These visits will help determine the effectiveness of the vaccine in reducing the risk of developing type 1 diabetes.
Step 4
End of study
The study is estimated to end by October 1, 2029. At the end of the study, the child's health and any developments related to type 1 diabetes will be evaluated.
The primary outcome of the study is to measure the time from the start of the treatment to the development of persistent confirmed islet autoantibodies or type 1 diabetes.

Who can join the trial?

3 criteria

Child must be between 3 and 4 months old at the time of joining the study.
Child must have a high genetic risk (more than 10%) of developing islet autoantibodies by age 6. This is determined by specific genetic markers called HLA DR/DQ genotype, a polygenic risk score, and having a close family member with type 1 diabetes.
A written informed consent must be signed by the child's parent(s) or guardian(s). This means the parent(s) agree to let their child participate in the study after being fully informed about it.

Who cannot join the trial?

7 criteria

Having any medical condition, other disease, or medical treatment that could interfere with the study tests or make participating in the study unsafe.
Having an immune deficiency, which is a condition where the body's immune system (the system that helps fight off germs and illnesses) does not work properly.
Using any treatments or having conditions that cause immune suppression, which means the body's ability to fight infections is weakened.
The possibility of not being able to follow the study rules properly, such as if you are planning to move to a different home or area soon.
Having been diagnosed with diabetes (a condition where blood sugar levels are too high) before joining the study.
Currently taking any other investigational drug, which is a medicine that is still being tested and is not yet widely available to the public.
Having a history of hypersensitivity, which is a medical term for an allergy or an extreme reaction, to any of the excipients (the inactive ingredients used to make the vaccine) in the medicine.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Katholieke Universiteit te Leuven
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Leuven, Belgium
Medical University Of Vienna
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Vienna, Austria
Region Skane Skanes Universitetssjukhus
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Lund, Sweden

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Investigated drugs

COVID-19 Vaccine is a medication used in this clinical trial. It is designed to protect against the COVID-19 virus. The vaccine works by helping the body develop immunity to the virus, which means it helps the body recognize and fight the virus if exposed in the future. In this trial, the vaccine is given to children who have a higher genetic risk of developing type 1 diabetes. The goal is to see if vaccinating these children can reduce the chances of them developing islet autoantibodies or type 1 diabetes as they grow up.

Raxtozinameran

What is already known about the treatment

COVID-19 Vaccine – This medication is administered as an injection, typically in the upper arm, and is designed to protect against the COVID-19 virus. In the context of the clinical trial, it is being studied for its potential to reduce the risk of developing type 1 diabetes in children who have a high genetic risk for the disease. The vaccine works by stimulating the immune system to recognize and fight the virus, potentially preventing infections that could trigger autoimmune responses leading to diabetes. It is classified as a vaccine, which is a type of biological preparation that provides active acquired immunity to a particular infectious disease.

Investigated diseases

Type 1 Diabetes – Type 1 Diabetes is a chronic condition where the pancreas produces little or no insulin due to an autoimmune reaction that destroys insulin-producing beta cells. This disease often begins in childhood or adolescence but can develop at any age. As the disease progresses, the lack of insulin leads to high blood sugar levels, which can cause symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The progression involves the gradual destruction of beta cells, leading to a complete lack of insulin production. The disease requires ongoing management to maintain blood sugar levels within a target range.