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COVID-19 shot tested to stop type 1 diabetes in kids

NCT ID NCT06452654

Prevention Sponsor: Technical University of Munich Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether giving the COVID-19 vaccine (Comirnaty) to children starting at 6 months old can lower their chance of developing type 1 diabetes. The trial will include 2,252 children who have a high genetic risk for the disease. Half will get the vaccine, half a placebo, and researchers will track who develops diabetes-related antibodies or type 1 diabetes over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
COVID-19 vaccine (Comirnaty)
What this could lead to
If it works, this could show that COVID-19 vaccination helps prevent type 1 diabetes in children with a high genetic risk.
What could go wrong
This is a large but early-stage prevention trial. It may not prove that the vaccine reduces diabetes risk, and results may take years. The vaccine has known side effects like fever or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 2,252 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 4 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Ages between 3.00 and 4.00 months at the time of enrollment. 2. A high genetic risk (\>10%) to develop islet autoantibodies by age 6 years as determined by a HLA DR/DQ genotype, polygenic risk score and first-degree family history of type 1 diabetes status. 3. Written informed consent signed by the custodial parent(s). Exclusion Criteria: 1. Previous hypersensitivity to the excipients of the vaccine. 2. Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study. These include immune deficiencies, and conditions or treatments that lead to immune suppression. 3. Likely poor compliance due to expected change in residency. 4. Diagnosis of diabetes prior to recruitment or randomisation 5. Current use of any other investigational drug

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Conditions

The condition(s) this trial relates to.

COVID-19 diabetes mellitus type 1 diabetes mellitus 1 viral infectious disease type 1 diabetes mellitus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AUF DER BULT, Kinder- und Jugendkrankenhaus

    RECRUITING

    Hanover, Lower Saxony, 30173, Germany

  • Birmingham Women's and Children's NHS Foundation Trust

    NOT_YET_RECRUITING

    Birmingham, United Kingdom

  • Cambridge University Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Cambridge, United Kingdom

  • Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich

    RECRUITING

    Munich, Bavaria, 80939, Germany

  • Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS

    RECRUITING

    Malmö, 20213, Sweden

  • Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria

    NOT_YET_RECRUITING

    Vienna, 1090, Austria

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    RECRUITING

    Newcastle, United Kingdom

  • University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven

    RECRUITING

    Leuven, 3000, Belgium

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