PROJECT 1

Islet autoantigen-derived peptides eluted from human HLA class II molecules as vaccines for the immunotherapy of type 1 diabetes:  a safety and proof of concept study in man

SUMMARY:

There is a class of proteins, called HLA, which act as “nametags” for the cells in your body.  When your immune system sees them on a cell, it knows not to attack.  In people suffering from autoimmune disease, like Type 1 Diabetes, the immune system mistakenly targets the body’s own tissues.  Research using animal models of Type 1 Diabetes has suggested that small fragments of these HLA “nametags” from the beta cells of the pancreas might be used as a vaccine to prevent the development of diabetes.  This study is a first step to testing the theory in humans, and is designed to ensure that HLA fragments are not dangerous.

PRINCIPAL INVESTIGATORS:

Dr Colin M. Dayan and Dr Susan Wong, University of Bristol
Dr Mark Peakman, King’s College London, UK

STUDY OBJECTIVES:

To determine whether intradermal administration of a soluble peptide sequence:

1. is safe particularly in terms of hypersensitivity reactions over a wide dose range;
2. can induce a regulated immune response.

PROJECT 2

A randomised, double-blind, placebo-controlled trial of intranasal insulin in children and young adults at risk of type 1 diabetes:  Intranasal Insulin Trial II (INIT II)

SUMMARY:

The first step towards developing Type 1 Diabetes is the development of an immune response to the beta cells of the pancreas.  Once the immune system has antibodies against these cells, it begins to destroy them, until eventually the pancreas can no longer produce insulin.  In animal models of diabetes, it was shown that inhalation of an insulin solution can prevent the immune system from switching into attack mode, even if it has started producing the antibodies.  The safety of inhaled insulin was tested and proven in a previous human trial, called INIT I.  The current trial, INIT II, is attempting to prevent the development of Type 1 Diabetes in people who already have at least two of the telltale antibodies in their blood.  The people being recruited for the trial are relatives of people with Type 1 Diabetes, because they are most at risk of developing the disease themselves.

PRINCIPAL INVESTIGATORS:

Prof. Leonard C. Harrison and Assoc. Prof Peter Colman, Royal Melbourne Hospital, Australia

CENTRES:

• Royal Melbourne Hospital; Royal Children’s Hospital (Melbourne)
• Mater Hospital (Brisbane)
• Women's & Children's Hospital (Adelaide)
• Princess Margaret Hospital (Perth)
• Westmead Hospital for Children; Royal North Shore Hospital (Sydney)
• Canberra Hospital (Canberra)
• Liggin’s Institute (Auckland, NZ)
• Christchurch Hospital (Christchurch, NZ)

STUDY OBJECTIVES:

To determine whether intranasal administration of insulin to children and young adults at risk of type 1 diabetes will:

1. reduce their rate of development of diabetes;
2. prevent expected loss of pancreatic β-cell function;
3. improve insulin action;
4. stimulate immune responses consistent with the induction of immune tolerance to insulin.

For more information please refer to: http://www.stopdiabetes.com.au

Click here to find out if you are eligible.