Immunotherapy

A method for assessing the efficacy of an immunotherapy administered to a patient, said immunotherapy comprising administration of GAD, comprising the following steps:

• measuring at least one of
• GADA IgG subclass distribution;
• GADA levels;
• Distribution of cytokines secreted from lymphocytes;
• and
• Lymphocyte proliferation in presence of GAD or CD3/CD28 beads;
• in a first blood, plasma or serum sample obtained from said patient at a first point in time and in a second blood, plasma or serum sample obtained from said patient at a second, later, point in time;
• Comparing the so obtained measurements;
• wherein an increased relative amount of IgG2, IgG3, and/or IgG4, or decreased relative amount of IgG1 in the GADA IgG subclass distribution;
• increased GADA levels;
• an increased relative amount of IL-13 and/or IL-5 or a decreased relative amount of IFNγ and/or TNFα in the distribution of cytokines secreted from lymphocytes;
• and/or reduced lymphocyte proliferation in the presence of GAD or CD3/CD28 beads;
• as measured in the second sample as compared to as measured in the first sample, is indicative of an effective immunotherapy.

A method for treatment or prevention of type 1 diabetes in a subject by means of immunotherapy, comprising the steps of

• administration of vitamin D commencing at day 1 and continuing for 3 to 6 months;
• three administrations of GAD into a lymph node at days 30, 60 and 90, respectively;
• and
• a fourth administration of GAD into a lymph node at a time between 12 and 18 months after day 1.