Identification of B Regulatory Cells by Flow Cytometry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHull University Teaching Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Patients aged 18 years or older
Participants over the age of 18 years
Disqualifiers
Patients under the age of 18 years
Samples from patients with IgE-mediated allergic disease, treated or untreated, specific to allergens other than pollens, house dust mite and insect venom
Participants who are pregnant
Participants who cannot adequately understand verbal and / or written explanations given in English
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Venepuncture
Diagnostic testWhole 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
Allergen Specific Immunotherapy
DrugTest 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).
Allergen Specific Immunotherapy
DrugTest 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).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Control Cohort1 intervention
Group B: Test Cohort2 interventions
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
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)Sponsors and contacts
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Hull University Teaching Hospitals NHS Trust
Lead sponsor
Health Education England, Wessex
Collaborator
University of Manchester
Collaborator
Source ClinicalTrials.gov