Anti-viral Action Against Type 1 Diabetes Autoimmunity

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.

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DRUG

Comirnaty Injectable Product

Vaccination

DRUG

Sodium Chloride 0.9% Inj

Vaccination

Sponsors & Collaborators

• Helmholtz Zentrum München

  collaborator INDUSTRY

• University Hospital Carl Gustav Carus

  collaborator OTHER

• Kinderkrankenhaus auf der Bult

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

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

  collaborator OTHER

• Technical University of Munich

  lead OTHER

Principal Investigators

• Anette-G. Ziegler · Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

4 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-08

Primary Completion

2027-10-31

Completion

2027-10-31

Countries

• Austria
• Belgium
• Germany
• Sweden
• United Kingdom

Study Locations