A pilot study to test if a vaccine against autoimmune destruction of the pancreatic insulin-producing cells, when injected directly into a lymph node, is safe and feasible for persons with the LADA (Latent Autoimmune Diabetes in Adults) type of diabetes.

Phase 1

• Conditions: MedDRA version: 21.0Level: PTClassification code 10066389Term: Latent autoimmune diabetes in adultsSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-002692-34-SE
• Lead Sponsor: TNU, Dept of Clinical and Molecular Medicine, Gastrosenteret

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-18
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.Signed informed consent by the patient.
2. Diagnosis of LADA and diabetes debut within the last 18 months before inclusion
3.Male or female between 30-70 years of age
4.Fasting C-peptide levels = 0.3 nmol/l
5.High anti-GAD titers (>190 U/ml)
6.Patients must be insulin independent at baseline by clinical judgement and C-peptide criteria
7.Antidiabetic medication in the form of metformin is acceptable for inclusion as well as medications not mentioned under exclusion criteria
8.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 GAD-alum

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1.Current or previous treatment with immunosuppressant therapy (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.Systemic treatment with glucocorticoids
4.Treatment with any vaccine, including influenza vaccine, within 1 month prior to planned first study drug dose or planned treatment with any vaccine up to 1 month after the last injection with study drug
5.Antidiabetic medication (metformin excepted)
6.Significantly abnormal hematology results at screening
7.A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
8.Clinically significant history of acute reaction to vaccines in the past.
9.Renal disease (as defined by serum creatinine >150 µmol/l)
10.Serious cardiovascular events (myocardial infarction, stroke) within the last year preceding recruitment.
11.Participation in other clinical trials with a new chemical entity within the previous 3 months
12.A history of alcohol or drug abuse
13. Known HIV or hepatitis
14.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
15.Other serious chronic disease as judged by investigator.
16.Females who are lactating, are pregnant or intend to become pregnant.
17.Inability or unwillingness to comply with the provisions of this protocol
18.Deemed by the investigator not being able to follow instructions and/or follow the study protocol
19. Treatment with any other supplementation of vitamin D, marketed or not, or unwilling to abstain from such medication during the 120 days daily intake of Divisun (non-investigational medicinal product)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified