Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a two centre, open-label, uncontrolled single group phase 1A study of C19-A3 GNP
      peptide (10 μg peptide equivalent content) administered via Nanopass microneedles every 28
      days for 8 weeks (3 doses), with follow-up for 6 weeks (14 weeks in total from first dose).
      Treatment will be given into the arm at a volume of 50ul.

      No blinding or randomisation will be performed. In keeping with standard phase 1 study
      designs, no placebo or control group is included as the primary aim is to establish whether
      there are any major unexpected safety issues in the use of this IMP for the first time in
      man. 8 subjects will be recruited at 2 centres: Cardiff, UK and Linköping, Sweden.
    

Detailed description: 
      Type 1 Diabetes is caused by the body's own white blood cells damaging the insulin producing
      cells in the pancreas.

      The aim is to develop a treatment that can slow or stop this process by switching off the
      white blood cells causing the damage. The aim of this study is to investigate whether giving
      such a treatment involving a peptide fragment related to insulin attached to gold
      nanoparticles is safe with no significant side-effects.

      Participants need to be:

        1. Diagnosed with type 1 diabetes for more than 3 months.

        2. Aged between 18 and 40 years.

        3. Prescribed insulin within 1 month of diagnosis. Participants will have a blood test to
           assess whether they have the right tissue type for the study. If suitable, they will be
           asked to attend their local research centre for a general examination and further blood
           and urine tests. If the participant still has some insulin response after the post meal
           urine test they will proceed to the first injection.

      Each participant will have 3 injections of the same treatment, these are given 4 weeks apart.
      During the treatment, participants will undergo various monitoring including blood & urine
      tests, mixed meal tolerance tests, lymph node biopsies. A follow up appointment will take
      place 6 weeks after the last injection. Possible side effects include bruising and discomfort
      at the site of the blood test and lymph node tests, local redness and swelling reactions at
      the site of the injections, severe allergic reaction to the injection requiring treatment,
      such as steroids, adrenaline or fluids.

      Participants will have more time with staff members to discuss their diabetes and ask
      questions than at a routine clinic appointment. It is not known whether receiving the gold
      particle-peptide injections will be of benefit, as this is the first study where the
      treatment is being used in humans.
    

Intervention name(s): C19-A3 GNP
Intervention type(s): Drug
Intervention description(s): C19A3 GNP intradermal microinjectable solution of human C19A3 proinsulin peptide coupled to gold.
Other intervention name(s): Human C19A3 proinsulin peptide coupled to gold.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention