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NOT YET RECRUITING
NCT06876506

Identification of B Regulatory Cells by Flow Cytometry

Sponsor: Hull University Teaching Hospitals NHS Trust

View on ClinicalTrials.gov

Summary

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.

Official title: Identification and Quantitation of Human B Regulatory Cells Via Flow Cytometry and Their Potential Role as a Treatment Efficacy Biomarker in Allergen-specific Immunotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2026-02-01

Completion Date

2027-07-31

Last Updated

2025-12-05

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Venepuncture

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

DRUG

Allergen Specific Immunotherapy

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).

DRUG

Allergen Specific Immunotherapy

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).

Locations (1)

Hull Teaching Hospital NHS Trust

Hull, East Yorkshire, United Kingdom