Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452654
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-22
Brief Title:
Anti-viral Action Against Type 1 Diabetes Autoimmunity
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Anti-viral Action Against Type 1 Diabetes Autoimmunity
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 XBB15 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 300 to 400 months baseline visit
Randomization to vaccine or placebo will occur at age 600 to 700 months at visit 2 Consent will be obtained by the custodial parents prior to enrollment
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 300 to 400 months baseline visit
Randomization to vaccine or placebo will occur at age 600 to 700 months at visit 2 Consent will be obtained by the custodial parents prior to enrollment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None