Identification of Regulatory B-cells by Flow Cytometry
Research type
Research Study
Full title
Identification and quantitation of human regulatory B cells via Flow Cytometry and their potential role as a treatment efficacy biomarker in allergen-specific immunotherapy.
IRAS ID
345343
Contact name
Kristina Emsell-Needham
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
Allergen immunotherapy (AIT) is a disease-modifying treatment for allergic disease which promotes immune system tolerance, i.e. reduces clinical manifestations of allergy and is the only known effective treatment to prevent anaphylaxis in patients who have previously had serious reactions to insect venoms. AIT induces a variety of immune system changes to facilitate this process, one mechanism of which is the production of a population of white blood cells called B-regulatory cells (BREGs). These cells release a chemical called interleukin-10 (IL-10) which inhibits (controls) the allergic immune response. The success of AIT is difficult to establish/monitor during treatment. Often treatment success can only be established at the end of a long treatment period (typically 3 years) and currently clinicians rely on reviewing changes in patient symptoms upon re-exposure to further allergen after treatment. Therefore there is a requirement to identify a marker (biomarker) which can be tested for during treatment to help clinicians establish at an earlier time, if the AIT is working successfully or if a change to treatment is required. This research will measure the BREG and IL-10 production in patients before and at multiple points during AIT, to establish if there is a relationship between the BREG/IL-10 concentration and the success or failure of AIT in controlling patient symptoms of allergy. The hope is that BREG measurement could be used in the future as a biomarker for AIT efficacy, and therefore provide evidence of AIT success sooner than current protocols, or may be used in establishing failure of AIT and therefore expediting a change in treatment. The latter may result in saving patient and clinician time in pursing a treatment which is not working, but may also aid in understanding when treatment has reached optimal effectiveness and can be stopped.
REC name
North West - Preston Research Ethics Committee
REC reference
25/NW/0181
Date of REC Opinion
29 Jul 2025
REC opinion
Further Information Favourable Opinion