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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Aaron Jackson
+44 (0)191 2825789
aaron.jackson@nhs.net


Dr Stephen Crulley
+44 (0)191 2820581
s.crulley@nhs.net


Dr Anette-Gabriele Ziegler
+49 (0)89 3187 2896
anette-g.ziegler@helmholtz-muenchen.de


Dr Catherine Owen
+44 (0)191 2825321
catherine.owen9@nhs.net


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Anti-viral action against Type 1 diabetes autoimmunity
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Anti-viral action against Type 1 diabetes autoimmunity

Recruiting

Open to: All Genders

Age: Child

Newcastle upon Tyne Cambridge Munich Hannover Dresden Malmö Leuven Warsaw Lodz

Medical Conditions

Type 1 diabetes

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The incidence of type 1 diabetes (T1D) increased sharply during the COVID-19 pandemic. Islet autoantibodies in the blood are the first signs of a child developing T1D. Research has shown that early childhood infection with the SARS-CoV-2 virus more than doubles the risk of developing islet autoantibodies. This virus can enter and infect the islet cells of the pancreas, so it is plausible this may increase susceptibility. The main aim of this study is to investigate whether vaccination against COVID-19 at the age of 6 months is superior to placebo in preventing the development of islet autoantibodies in children at increased genetic risk of T1D.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

23 Oct 2024 31 Jul 2027

Participants will receive vaccination with BioNTech/Pfizer Comirnaty 3 mcg in three doses between 6 and 11 months of age. Half of the recruited patients will receive the SARS-CoV-2 vaccine and half will receive placebo vaccination (normal saline). Ongoing monitoring visits will occur post-vaccination for 2-1/2 to 6 years, depending on when the participants is recruited into the study. Blood and stool samples will be collected at each visit and participants will collect weekly saliva samples and monthly stool samples at home for infection surveillance. They will also complete a fortnightly questionnaires for the first 24 months around infections and twice during the study around physical and mental health.


Patients aged between 3 and 4 months with a high genetic risk of developing T1D (identified from the currently running INGRID-2 trial)

You can take part if:



You may not be able to take part if:


1. Previous hypersensitivity to the excipients of the vaccine. These include: 1.1. ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) 1.2. 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) 1.3. 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC) 1.4. Cholesterol 1.5. Trometamol 1.6. Trometamol hydrochloride 1.7. Sucrose2. 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.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Victoria Infirmary
    Queen Victoria Road
    Newcastle upon Tyne
    TS1 4LP
  • Cambridge Biomedical Campus
    Hills Road
    Cambridge
    CB2 0QQ
  • Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research
    Helmholtz Munich Heidemannstr.1
    Munich
    80939
  • AUF DER BULT, Kinder- und Jugendkrankenhaus
    Hannover
    -
  • Klinik und Poliklinik f. Kinder und Jugendmedizin
    Universitätsklinikum Carl Gustav Carus Technische Universität Dresden
    Dresden
    -
  • Lund University
    Skane University Hospital SUS
    Malmö
    -
  • University Hospitals Leuven
    Faculty of Medicine Catholic University of Leuven
    Leuven
    -
  • Medical University of Warsaw
    Department of Paediatrics
    Warsaw
    -
  • Medical University of Lodz
    Department of Paediatrics
    Lodz
    -

A potential benefit is the prevention or delay of developing islet autoantibodies and type 1 diabetes. Such a benefit can not be guaranteed, however, regular blood testing will help to detect and closely monitor the early stages of type 1 diabetes which can reduce the risk of complications.
The vaccine that will be used in the study will be Comirnaty® Omicron XBB.1.5, which is approved in the UK from 6 months of age. For primary vaccination it is given in three doses of 3 µg each; the first two doses are given 3 to 6 weeks apart, followed by a third dose given at least 8 weeks after the second dose. For children within these age groups, the vaccine is given as injections in the muscles of the thigh. The most common side effects (listed in SmPC as >1/1,000) in children aged from 6 months to 4 or 5 years were comparable to those seen in older age groups. Irritability, sleepiness, loss of appetite, rash, mild temperatures, diarrhoea and less commonly vomiting, lymphadenopathy and night sweats. Redness, swelling and tenderness at the injection site were also common side effects in children aged 6 to 23 months. These effects were usually mild or moderate and improved within a few days of vaccination. Rarer side effects (<1/1,000) are detailed in the SmPC for the vaccine. The researchers will ensure participants' families are aware of these potential side effects and will be given advice on how to minimise these.
The blood samples taken as part of the trial involve risks such as slight pain or bruising at the injection site and occasional discomfort. This will be minimised as much as possible by using on-site staff who are skilled in paediatric phlebotomy and distraction techniques, as well as the use of anaesthetic cream/spray at the puncture site.
The study involves a large number of procedures, especially up to age 2 years. These include frequent study visits and blood draws, up to weekly collection of saliva samples, monthly collection of stool samples and responding to questions fortnightly. This is considerably more than what is standard care during this age and may be burdensome for children and participating families. The extent of the procedures as compared to standard care will be explained during the consent process. In a previous study, which enrolled children from age 4 months for a similar study duration and blood draw schedule, the study drop-out rate was low (<10%). Therefore, the study procedures are considered tolerable to the majority of participants and families. The psychological questionnaire will monitor and identify families requiring attention due to participation demands and solutions to reduce the demands such as less frequent sampling or questionnaires will be discussed with these families. The researchers will try to ensure that all appointments are run as promptly and smoothly as possible to minimise time commitment.
Children in the placebo group will be denied access to the benefits of a COVID-19 vaccine, including the possible prevention of serious early and late complications from a COVID-19 infection. The current number of children below the age of 5 years who are provided with this benefit through vaccination is extremely low (<0.1%). Further mitigation of the risk includes excluding children with diseases or treatments that lead to immune deficiency. This exclusion helps minimize the potential risk for this specific group of participants. In the UK, COVID-19 vaccination for children this age is only advised for those in a clinical risk group, so participation would not be depriving them of routinely receiving the vaccination.
Other viral infections such as Coxsackie B virus infection are associated with the development of islet autoantibodies. Therefore, the effectiveness of COVID-19 vaccination in preventing islet autoimmunity associated with COVID-19 infection will not prevent the occurrence of islet autoimmunity associated with other causes. The development of islet autoantibodies or type 1 diabetes may alter the behaviour of parents or guardians to the child and may affect further family planning or might cause psychological stress. Parental/guardian well-being is monitored via a psychological questionnaire. The development of islet autoantibodies may also affect the insurance options of the participant.

Dr Stephen Crulley
+44 (0)191 2820581
s.crulley@nhs.net


Dr Catherine Owen
+44 (0)191 2825321
catherine.owen9@nhs.net


Dr Aaron Jackson
+44 (0)191 2825789
aaron.jackson@nhs.net


Dr Anette-Gabriele Ziegler
+49 (0)89 3187 2896
anette-g.ziegler@helmholtz-muenchen.de



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Klinikum rechts der Isar Technische Universitat and funded by Leona M. and Harry B. Helmsley Charitable Trust.




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Read full details for Trial ID: ISRCTN82491599

Or CPMS 62174

Last updated 28 October 2024

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