Immunolep v1.0
Research type
Research Study
Full title
Molecular dissection of immunopathology in leprosy
IRAS ID
334777
Contact name
Gabriele Pollara
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2023/12/92, UCL Data Protection Registration Number
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
Leprosy is a disabling and stigmatised disease, with >200,000 cases reported to the World Health Organization annually. Leprosy is caused by infection with the bacterium Mycobacterium leprae and causes a range of symptoms affecting the skin and nerves, leading to pain, numbness, loss of function and permanent deformity. There is effective antibiotic treatment for the initial infection, but despite killing the bacteria, approximately half of individuals experience severe inflammatory complications called ‘reactions’. Leprosy reactions are not the result of relapsed infection, but are due to the immune system causing inflammation. There are different ways to classify reactions, but they are all painful and result in nerve damage, which can cause disability. It is not currently possible to predict which individuals develop leprosy reactions and the specific changes in the immune system responsible for them are unknown.
Large doses of steroids are the first line treatment to control reactions. These need to be taken for many months and cause significant side effects, including infections, high blood pressure, cataracts, weight gain, diabetes and osteoporosis. Steroids control the inflammation but do not address the underlying cause of the reactions. Not all individuals respond well to steroids, and patients often experience deterioration in symptoms and further disability. Our project will look to understand which patients will develop reactions and discover better treatments to treat the damaging immune responses in reactions.
At the time of regular clinic visits, we will recruit patients at several stages of their leprosy disease. We will take blood samples and small biopsies from skin affected by leprosy and reactions. We will look for the immune genes that are more active in each reaction type and in individuals in whom reactions do not respond well to steroids, to discover what harmful immune responses remain despite steroid treatment.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0043
Date of REC Opinion
25 Jan 2024
REC opinion
Favourable Opinion