Evaluation of a Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes

Exclusion Criteria

• •1. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
• •2. Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
• •3. Treatment with any oral or injected anti-diabetic medications other than insulin
• •4. Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the supplementation period
• •5. A history of anemia or significantly abnormal hematology results at screening
• •6. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
• •7. Clinically significant history of acute reaction to vaccines or other drugs in the past, including Diamyd
• •8. Treatment with any vaccine, including influenza or Covid19 vaccine, within 1 month prior to planned study drug dose administration or planned treatment with any vaccine up to 1 month after the injection with study drug
• •9. Participation in clinical trials (other than DIAGNODE-1 and DIAGNODE-2) with a new chemical entity within the previous 3 months
• •10. Inability or unwillingness to comply with the provisions of this protocol
• •11. A history of alcohol or drug abuse
• •12. A significant illness other than diabetes within 2 weeks prior to first dosing s
• •13. Ongoing diagnosed or suspected post-Covid19 syndrome
• •14. Known HIV or hepatitis
• •15. Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the Diamyd treatment)
• •16. Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
• •17. Deemed by the investigator not being able to follow instructions and/or follow the study protocol