Diabetes Mellitus, Type 1Phase 4NCT06452654
Anti-viral Action Against Type 1 Diabetes Autoimmunity
A Phase 4 study testing Comirnaty Injectable Product and Sodium Chloride 0.9% Inj in people with Diabetes Mellitus, Type 1, run by Technical University of Munich at 9 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Comirnaty Injectable Product and Sodium Chloride 0.9% Inj
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,252 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 8 May 2024to Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
- Likely poor compliance due to expected change in residency.
- Diagnosis of diabetes prior to recruitment or randomisation
- Current use of any other investigational drug
Trial locations and contacts
9 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 5 countries
Germany3 sites, 3 recruiting
- Recruiting
Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden
Dresden, Saxony, 01307
Reinhard Berner, Prof.Dr.
- Recruiting
AUF DER BULT, Kinder- und Jugendkrankenhaus
Hanover, Lower Saxony, 30173
Olga Kordonouri, Prof. Dr.
- Recruiting
Klinikum rechts der Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich
Munich, Bavaria, 80939
Anette-G Ziegler, Prof. Dr., +49-89-3187 ext. 2896, anettegabriele.ziegler@helmholtz-munich.de
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Birmingham Women's and Children's NHS Foundation Trust
Birmingham
Renuka Dias
- Not yet recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Loredana Marcovecchio, MD, PhD
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle
Catherine Owen, PhD
Austria1 site, 1 recruiting
- Not yet recruiting
Medical University of Vienna, Dept. of Pediatric and Adolescent Medicine, Waehringer Gürtel 18-20, 1090 Vienna, Austria
Vienna, 1090
Birgit Rami-Merhar, Prof., +43-1-40400-32320, Birgit.Rami@meduniwien.ac.at
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven
Leuven, 3000
Kristina Casteels, Prof. Dr.
Sweden1 site, 1 recruiting
- Recruiting
Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS
Malmö, 20213
Marcus Lundgren, Dr.
About this study
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.
Read more
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:
- to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood.
- to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and
- 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Comirnaty Injectable Product, Sodium Chloride 0.9% Inj
- Keywords
- Type 1 diabetes, T1D, Diabetes mellitus, Autoantigen, Prevention, at risk for developing type 1 diabetes, Juvenile diabetes, Autoimmune diabetes, Corona, COVID-19, Viral infection, Viral infection surveillance, Immune response, Metabolism
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, COVID-19, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comirnaty Injectable ProductDrug
Also called Comirnaty 3µg/dose for children for 6 month - 4 years
Vaccination
Sodium Chloride 0.9% InjDrug
Also called Solution for Injection
Vaccination
| Study group | Role | What they receive |
|---|---|---|
| Verum | Active comparator | Comirnaty® 3 µg Omicron XBB.1.5 or future new variant developments replacing current Comirnaty vaccines for children
Suspension for injection, for intramuscular use
1. st dose at age 6.0 to 7.0 months
2. nd dose at least 3 weeks through to 6 weeks after 1st dose
3. rd dose at least 8 weeks after 2nd dose (around age 8.5 to 11 months)
Dose adjustment in case of COVID-19 infection. Receives: Drug: Comirnaty Injectable Product |
| Placebo | Placebo comparator | 0.9 % Sodium Chloride Solution (saline) for intramuscular injection Dosing: three doses
1. st dose at age 6.0 to 7.0 months
2. nd dose at least 3 weeks through to 6 weeks after 1st dose
3. rd dose at least 8 weeks after 2nd dose (around age 8.5 to 11 months) Receives: Drug: Sodium Chloride 0.9% Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent confirmed islet autoantibodies or type 1 diabetes
The primary outcome is the elapsed time from first vaccination to the development of persistent confirmed islet autoantibodies or type 1 diabetes.
Measured: Through study completion, up to 6 years
Secondary outcomes (3)
Persistent confirmed multiple islet autoantibodies
Elapsed time from first vaccination to persistent confirmed multiple islet autoantibodies;
Measured: Through study completion, up to 6 years
Type 1 diabetes
Elapsed time from first vaccination to type 1 diabetes.
Measured: Through study completion, up to 6 years
Persistent confirmed transglutaminase autoantibodies
Elapsed time from first vaccination to the development of persistent confirmed transglutaminase autoantibodies.
Measured: Through study completion, up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start8 May 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Helmholtz Zentrum München, University Hospital Carl Gustav Carus, Kinderkrankenhaus auf der Bult, Skane University Hospital, Universitaire Ziekenhuizen KU Leuven, Newcastle-upon-Tyne Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Anette-G. Ziegler, Principal investigator, Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452654
- Sponsor's protocol ID
- GPPAD-05-AVAnT1A
- Status last verified
- Sep 2025
- First submitted
- 22 May 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-viral Action Against Type 1 Diabetes Autoimmunity
- ClinicalTrials.gov ID
- NCT06452654
- Acronym / sponsor ID
- GPPAD-05-AVAnT1A
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 diabetes, T1D, Diabetes mellitus, Autoantigen, Prevention, at risk for developing type 1 diabetes, Juvenile diabetes, Autoimmune diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,252 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Helmholtz Zentrum München, University Hospital Carl Gustav Carus, Kinderkrankenhaus auf der Bult, Skane University Hospital, Universitaire Ziekenhuizen KU Leuven, Newcastle-upon-Tyne Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust
- Study start
- 8 May 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood.
- to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Active comparator | Drug: Comirnaty Injectable ProductComirnaty® 3 µg Omicron XBB.1.5 or future new variant developments replacing current Comirnaty vaccines for children Suspension for injection, for intramuscular use 1. st dose at age 6.0 to 7.0 months 2. nd dose at least 3 weeks through to 6 weeks after 1st dose 3. rd dose at least 8 weeks after 2nd dose (around age 8.5 to 11 months) Dose adjustment in case of COVID-19 infection. |
| Placebo | Placebo comparator | Drug: Sodium Chloride 0.9% Inj0.9 % Sodium Chloride Solution (saline) for intramuscular injection Dosing: three doses 1. st dose at age 6.0 to 7.0 months 2. nd dose at least 3 weeks through to 6 weeks after 1st dose 3. rd dose at least 8 weeks after 2nd dose (around age 8.5 to 11 months) |
Who may qualify
- Ages
- 3 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
- Likely poor compliance due to expected change in residency.
- Diagnosis of diabetes prior to recruitment or randomisation
- Current use of any other investigational drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comirnaty Injectable ProductAlso: Comirnaty 3µg/dose for children for 6 month - 4 yearsVaccination | Drug | Verum |
| Sodium Chloride 0.9% InjAlso: Solution for InjectionVaccination | Drug | Placebo |
Primary outcome
Persistent confirmed islet autoantibodies or type 1 diabetes
Time frame: Through study completion, up to 6 years
The primary outcome is the elapsed time from first vaccination to the development of persistent confirmed islet autoantibodies or type 1 diabetes.
3 secondary outcomes
Persistent confirmed multiple islet autoantibodies
Time frame: Through study completion, up to 6 years
Type 1 diabetes
Time frame: Through study completion, up to 6 years
Persistent confirmed transglutaminase autoantibodies
Time frame: Through study completion, up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anette-G. Ziegler principal investigator
Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Comirnaty Injectable Product and Sodium Chloride 0.9% Inj in people with Diabetes Mellitus, Type 1, run by Technical University of Munich at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, United Kingdom, Austria, Belgium, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anette-G. Ziegler, Prof. Dr. (+49-89-3187 ext. 2896, anettegabriele.ziegler@helmholtz-munich.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent confirmed islet autoantibodies or type 1 diabetes (time frame: Through study completion, up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.