An observational study in Pollen Allergy and Venom Allergy, sponsored by Hull University Teaching Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Hull University Teaching Hospitals NHS Trust · Observational
The goal of this laboratory and observational study is to develop a test to quantify B-regulatory cells in blood. This will be used to detect changes in B-regulatory cell populations in pollen and insect venom allergic patients who are receiving routine allergen immunotherapy treatment. The primary question this study aims to answer is;
1). Are changes in blood B-regulatory cells associated with successful allergen immunotherapy treatment, and therefore do these changes suggest patients have developed a suitable level of allergen tolerance and reduction in their allergic symptoms upon re-exposure to the causal allergen.
Patients will also be asked to complete quality of life questionnaire periodically throughout the study to determine if there are associations between variation in B-regulatory cell populations in blood and allergic symptoms experienced.
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 patient symptoms upon re-exposure to further allergen post-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 showing success 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 establishing failure of AIT and therefore expediting a change in treatment. The latter will likely result in saving time in pursuing a treatment which is not working, but also for understanding when the treatment has already reached optimal effectiveness and can be stopped.
Overall Aim:
To develop a flow cytometry assay for the identification and quantitation of human B regulatory cells to allow evaluation of their potential role as a treatment efficacy biomarker in allergen-specific immunotherapy.
Primary Objectives:
Secondary Objectives:
404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.
This study's planned enrollment of 80 is close to the median of 86 across 32 observational studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →Hull University Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants routinely attending the Immunology and Allergy Clinical at Hull University Teaching Hospitals Test cohort patients - selected from patients who meet eligibility criteria of the study, and who are starting routine allergen immunotherapy as part of their routine care outside of the study Allergen immunotherapy candidates to receive venom (bee/wasp), house dust mite or pollen immunotherapy only to be included in the study
Control cohort - Participants with:
Test cohort:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Participants routinely attending the Immunology and Allergy Clinical at Hull University Teaching Hospitals * Participants over the age of 18 years * Participants with no clinical and laboratory findings of IgE-mediated hypersensitivity (i.e. no clinical history of specific allergies to pollens, house dust mite or insect venoms, negative serological testing for specific IgE to pollens, house dust mite and insect venoms)
Diagnostic Test: Venepuncture
1. Participants routinely attending the Immunology and Allergy Clinical at Hull University Teaching Hospitals 2. Participants over the age of 18 years 3. Participants with physician-diagnosed IgE-mediated allergic disease to pollens, house dust mite or insect venoms 4. Participants who are eligible to commence allergen immunotherapy (AIT). AIT will comprise; * Sublingual immunotherapy (SLIT) Grazax for grass pollen allergy or Acarizax for house dust mite allergy * Subcutaneous immunotherapy (SCIT) Venom immunotherapy involving subcutaneous injections against bee or wasp venoms (as per schedule following conventional or modified rush protocols) AIT eligibility decided upon through combination of clinical assessment, multi-disciplinary team (MDT) meeting discussion and BSACI guidance.
Diagnostic Test: Venepuncture · Drug: Allergen Specific Immunotherapy
Whole blood flow cytometry analysis of T-/B-lymphocyte subsets, regulatory B cells and regulatory T cells. Serological detection (immunoassay) of allergen-specific IgE and IgG4
Test group receiving venom allergen immunotherapy as part of standard and routine care pathway (treatment commencement NOT for study purposes, cohort selected of those who are routinely commencing treatment).
Test group receiving pollen allergen immunotherapy as part of standard and routine care pathway (treatment commencement NOT for study purposes, cohort selected of those who are routinely commencing treatment).
Utility of B regulatory cells as a biomarker of AIT treatment sucess
To assess whether an increase in regulatory B cell concentration is a useful biomarker to indicate AIT treatment success and specific allergen de-sensitisation.
Time frame: From enrolment to 1 year post commencing allergen-specific immunotherapy treatment
Develop a flow cytometry laboratory assay for the detection of B regulatory cells
Development of a flow cytometry protocol that accurately detects and quantifies the regulatory B cell populations
Time frame: From study commencement (planned May 2025) to end of study data collection (planned May 2027)
Plan to share: No — No current plans to make IPD fully available to other researches at this time
Started Jan 2026 (actual). Primary completion is estimated for May 2027, 16 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rhinitis, Allergic, Seasonal →
Hull University Teaching Hospitals NHS Trust