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Anti-viral action against Type 1 diabetes autoimmunity GPPAD-05-AVAnT1A

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507348-35-00
Enrollment
2165
Registered
2024-04-11
Start date
2024-05-30
Completion date
Unknown
Last updated
2025-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk for Type 1 Diabetes

Brief summary

The primary efficacy outcome is the elapsed time from random treatment assignment to the development of persistent confirmed islet autoantibod-ies or type 1 diabetes

Detailed description

The elapsed time from random treatment assignment to the development of per-sistent confirmed multiple islet autoan-tibodies; the development of type 1 diabetes; the development of persistent con-firmed transglutaminase autoantibodies

Interventions

DRUGComirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
DRUG0.9% Sodium Chloride solution for injection (saline)

Sponsors

Klinikum rechts der Isar der TU Muenchen AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
The primary efficacy outcome is the elapsed time from random treatment assignment to the development of persistent confirmed islet autoantibod-ies or type 1 diabetes

Secondary

MeasureTime frame
The elapsed time from random treatment assignment to the development of per-sistent confirmed multiple islet autoan-tibodies; the development of type 1 diabetes; the development of persistent con-firmed transglutaminase autoantibodies

Countries

Austria, Belgium, Germany, Italy, Poland, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026