Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes

Inclusion Criteria:

1. Informed consent given by patients and/or patient's parent(s) or legal acceptablerepresentative(s) (guardian(s)) according to national regulations
2. Type 1 Diabetes (T1D) according to the Amercian Diabetes Association (ADA)classification diagnosed ≤6 months at the time of screening
3. Age: ≥12 and <25 years old
4. Fasting C-peptide ≥0.12 nmol/L (0.36 ng/ml) on at least one occasion (maximum 2 testson different days within a period of 2 weeks)
5. Positive for Glutamic Acid Decarboxylase isoform 65 (GAD65A) but < 50 000 IU/ml
6. Females must agree to avoid pregnancy and have a negative urine pregnancy test.Patients of childbearing potential must agree to use adequate contraception, until one (1) year after the last administration of Diamyd. Adequate contraception is asfollows: For females of childbearing potential:
7. oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, orimplanted hormonal contraceptives
8. combined (estrogen and progestogen containing)
9. oral, intravaginal or transdermal progesterone hormonal contraception associated withinhibition of ovulation
10. intrauterine device
11. intrauterine hormone-releasing system (for example, progestin-releasing coil)
12. bilateral tubal occlusion
13. vasectomized male (with appropriate post vasectomy documentation of the absence ofsperm in the ejaculate)
14. male partner using condom
15. abstinence from heterosexual intercourse For males of childbearing potential:
16. condom (male)
17. abstinence from heterosexual intercourse

Exclusion Criteria:

1. Previous or current treatment with immunosuppressant therapy (although topical orinhaled steroids are accepted)
2. Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because ofheadache 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. A history of anemia or significantly abnormal hematology results at screening
5. A history of epilepsy, head trauma or cerebrovascular accident, or clinical featuresof continuous motor unit activity in proximal muscles
6. Clinically significant history of acute reaction to vaccines or other drugs in thepast
7. Treatment with any vaccine, including influenza vaccine, within 4 months prior toplanned first study drug dose or planned treatment with any vaccine up to 4 monthsafter the last injection with study drug.
8. Participation in other clinical trials with a new chemical entity within the previous 3 months
9. Inability or unwillingness to comply with the provisions of this protocol
10. A history of alcohol or drug abuse
11. A significant illness other than diabetes within 2 weeks prior to first dosing
12. Known HIV or hepatitis
13. Females who are lactating or pregnant (the possibility of pregnancy must be excludedby urine βHCG on-site within 24 hours prior to the Diamyd/placebo treatment)
14. Presence of associated serious disease or condition, including active skin infectionsthat preclude intralymphatic injection, which in the opinion of the investigator makesthe patient non-eligible for the study
15. Deemed by the investigator not being able to follow instructions and/or follow thestudy protocol