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.
Who can participate
Age range
3 Months – 4 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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, polygenic risk score and first-degree family history of type 1 diabetes status.
. Written informed consent signed by the custodial parent(s).
Exclusion criteria
. Previous hypersensitivity to the excipients of the vaccine.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Persistent confirmed islet autoantibodies or type 1 diabetes
Timeframe: Through study completion, up to 6 years