At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Comirnaty Injectable Product (drug), Sodium Chloride 0.9% Inj (drug)
- How long the study runs
- Study runs about 41 months (dates as stated)
- About the drug or intervention
- Comirnaty Injectable Product — drug: Vaccination · Sodium Chloride 0.9% Inj — drug: Vaccination
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the Technical University of Munich, is looking at babies aged 3 to 4 months who have a high genetic risk (more than 10%) of developing early signs of type 1 diabetes by age 6. The study involves an anti-viral vaccine, but further details are not stated — ask the trial team.
Who can take part
- Babies aged between 3 and 4 months when they join the study.
- High genetic risk (more than 10 in 100 chance) of developing islet autoantibodies (early signs linked to type 1 diabetes) by age 6. This is worked out using genetic testing and whether a close family member has type 1 diabetes.
- A parent or legal guardian must give written informed consent.
Who may not be able to
- A past serious allergic reaction to any ingredient of the vaccine.
- Any illness, condition or treatment that could affect the study or make taking part unsafe, including problems that weaken the immune system or medicines that suppress it.
- Families likely to move home in a way that would make it hard to stay in the study.
- Already diagnosed with diabetes before joining.
- Currently taking any other experimental (investigational) medicine.
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 3 Months to 4 Months
- Who
- All
- Number of participants
- 2,252
- Started
- 2024-05-08
- Last checked
- 2025-09
Plain English Summary
What is this study?
- • Testing a new treatment for diabetes mellitus, type 1
- • Phase4 - 2,252 participants
- • The study GPPAD-05 AVAnT1A is a phase 4 clinical trial intending to enroll 2252 children, who will be randomly assigned to receive COVID-19 vaccination (Comirnaty® 3 μg Omicron XBB
Who can take part?
- • Ages 3 Months to 4 Months
- • Diagnosed with diabetes mellitus, type 1
Where?
- • Birmingham - Birmingham Women's and Children's NHS Foundation Trust
- • Cambridge - Cambridge University Hospitals NHS Foundation Trust
- • Newcastle - The Newcastle upon Tyne Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The study GPPAD-05 AVAnT1A is a phase 4 clinical trial intending to enroll 2252 children, who will be randomly assigned to receive COVID-19 vaccination (Comirnaty® 3 μg Omicron XBB.1.5 or new variant Comirnaty vaccines ) or placebo from age 6 months. The study is an investigator initiated, randomized, controlled, multicentre, multinational, primary prevention trial for children at increased risk of type 1 diabetes. The primary objective is to determine whether vaccination of children with elevated genetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood. Secondary objectives are: 1. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood. 2. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and 3. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of celiac disease-associated transglutaminase autoantibodies in childhood. Further exploratory objectives are described in the study protocol. Study participants will be identified through an ongoing study screening for genetic risk of type 1 diabetes using a polygenic risk score (NCT03316261). Eligible participants will be enrolled at age 3.00 to 4.00 months (baseline visit). Randomization to vaccine or placebo will occur at age 6.00 to 7.00 months at visit 2. Consent will be obtained by the custodial parents prior to enrollment.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 3 Months - 4 Months
- Who can join: All genders
What the study is looking for
- ✓Ages between 3.00 and 4.00 months at the time of enrollment.
- ✓A high genetic risk (\>10%) to develop islet autoantibodies by age 6 years as determined by a HLA DR/DQ genotype,...
- ✓Written agreement to take part signed by the custodial parent(s).
Who cannot take part
- ✗Previous hypersensitivity to the excipients of the vaccine.
- ✗Likely poor compliance due to expected change in residency.
- ✗Diagnosis of diabetes prior to recruitment or randomisation
- ✗Current use of any other investigational drug
See the full criteria
Where Is This Study? (3 UK sites)
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
How to Get in Touch
Anette-G. Ziegler, Prof. Dr.
Sponsor contactCONTACT
Peter Achenbach, Prof. Dr.
Sponsor contactCONTACT