Identification of B Regulatory Cells by Flow Cytometry

NCT06876506 | Not Yet Recruiting

• 1 other identifier: IRAS ID 345343
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pollen Allergy; Venom Allergy

Keywords

Pollen Allergy; Venom Allergy; Allergen Immunotherapy; B-regulatory cells; dust mite allergy

Outcome Measures

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.

  From enrolment to 1 year post commencing allergen-specific immunotherapy treatment

Secondary Outcomes (1)

• Develop a flow cytometry laboratory assay for the detection of B regulatory cells

  From study commencement (planned May 2025) to end of study data collection (planned May 2027)

Study Arms (2)

Control Cohort

* 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

Test Cohort

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

Interventions

Venepuncture DIAGNOSTIC_TEST

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

Control Cohort; Test Cohort

Allergen Specific Immunotherapy DRUG

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 Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: collaborator
• Hull University Teaching Hospitals NHS Trust: lead
• Health Education England, Wessex: collaborator

Study Sites (1)

Hull Teaching Hospital NHS Trust

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Related Publications (3)

• Durham SR, Shamji MH. Allergen immunotherapy: past, present and future. Nat Rev Immunol. 2023 May;23(5):317-328. doi: 10.1038/s41577-022-00786-1. Epub 2022 Oct 17.

  PMID: 36253555 BACKGROUND

• Sahiner UM, Giovannini M, Escribese MM, Paoletti G, Heffler E, Alvaro Lozano M, Barber D, Canonica GW, Pfaar O. Mechanisms of Allergen Immunotherapy and Potential Biomarkers for Clinical Evaluation. J Pers Med. 2023 May 17;13(5):845. doi: 10.3390/jpm13050845.

  PMID: 37241015 BACKGROUND

• Alvaro-Lozano M, Akdis CA, Akdis M, Alviani C, Angier E, Arasi S, Arzt-Gradwohl L, Barber D, Bazire R, Cavkaytar O, Comberiati P, Dramburg S, Durham SR, Eifan AO, Forchert L, Halken S, Kirtland M, Kucuksezer UC, Layhadi JA, Matricardi PM, Muraro A, Ozdemir C, Pajno GB, Pfaar O, Potapova E, Riggioni C, Roberts G, Rodriguez Del Rio P, Shamji MH, Sturm GJ, Vazquez-Ortiz M. EAACI Allergen Immunotherapy User's Guide. Pediatr Allergy Immunol. 2020 May;31 Suppl 25(Suppl 25):1-101. doi: 10.1111/pai.13189.

  PMID: 32436290 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum (separated from whole blood) samples only

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Venom Hypersensitivity; Dust Mite Allergy

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic, Perennial

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Kristina Emsell-Needham, BSc, MSc

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Emsell-Needham, BSc, MSc

CONTACT

+441482607813; Kristina.Emsell-Needham@nhs.net

Sujoy Khan, MD, MBBS, FRCPE

CONTACT

sujoy.Khan@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)