Tolerance in Beekeepers

NCT06156046 | Recruiting

• 1 other identifier: 330722
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Beekeepers experience multiple bee stings each year. Many of these beekeepers (25-60%) become sensitized to bee venom through the production of specific antibodies that target the bee venom. Although these antibodies are important in the triggering of an allergic reaction only a small number of sensitised beekeepers go on to have an allergic reaction with symptoms away from the site of the sting. These reactions can be severe and are known as anaphylactic reactions. The study investigates why some beekeepers develop severe allergic symptoms after bee stings while others do not. This study will explore factors in the blood that protect sensitised individuals from having anaphylactic reactions - meaning that despite being sensitised they are tolerant and do not react to subsequent stings.

Conditions

Bee Sting

Keywords

Immune tolerance; Anaphylaxis; Beekeepers

Outcome Measures

Primary Outcomes (4)

• Cell comparison

  (i) To compare the number of various cell (CD4+, CD8+ and Treg etc.) populations in the non-sensitised control population (NS), the sensitised but tolerant beekeepers (TB) and the allergic beekeeper (AB) population.

  3 years

• Cellular function

  (ii) To identify differences in cellular function in the non-sensitised control population (NS), the sensitised but tolerant beekeepers (TB) and the allergic beekeeper (AB) population.

  3 years

• Molecular mechanism

  (iii) To elucidate the molecular mechanism and the differences observed in (i) and (ii).

  3 years

• Epi regulation

  (iiii) To elucidate the epigenetic regulation underpinning and the differences observed in (i) and (ii)

  3 years

Secondary Outcomes (2)

• Sensitisation data- skin prick testing

  3 years

• Sensitisation data - specific IgE's in blood

  3 years

Study Arms (3)

Group 1

Individuals naïve to beekeeping (\<2 previous bee stings, non in the last 24 months). No history of anaphylaxis

Diagnostic Test: skin prick test; Diagnostic Test: Blood tests

Group 2

Beekeepers with \> approximately 10 stings/year who have been beekeeping for \>3 years. No history of anaphylaxis.

Diagnostic Test: skin prick test; Diagnostic Test: Blood tests

Group 3

Beekeepers with diagnosis of anaphylaxis to bee venom in the last 12 months who are sensitised to bee venom ( as evidenced by positive IgE and positive skin test to bee venom)

Diagnostic Test: skin prick test; Diagnostic Test: Blood tests

Interventions

skin prick test DIAGNOSTIC_TEST

Skin prick test for bee venom

Group 1; Group 2; Group 3

Blood tests DIAGNOSTIC_TEST

IgE/G and T cell tolerance studies

Group 1; Group 2; Group 3

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

Group 1 inclusion criteria. Individuals naive to beekeeping (\<2 previous bee stings, none in the last 24 months). No history of anaphylaxis to bee stings. Group 2 inclusion criteria. Beekeepers with \> approximately 10 stings/year who have been beekeeping for \>3 years. No history of anaphylaxis to bee stings. Group 3 inclusion criteria Beekeepers with diagnosis of anaphylaxis to bee venom in the last 12 months who are sensitised to bee venom (as evidenced by positive specific IgE and positive skin test to bee venom).

You may qualify if:

• Individuals naive to beekeeping (\<2 previous bee stings, none in the last 24 months)
• Beekeepers with \> approximately 10 stings/year who have been beekeeping for \>3 years.
• Beekeepers with diagnosis of anaphylaxis to bee venom in the last 12 months who are sensitised to bee venom (as evidenced by positive specific IgE and positive skin test to bee venom)

You may not qualify if:

• Unable to understand protocol/consent.
• Unable to commit to follow up visits.
• Participants with a known history of mastocytosis or under investigation for suspected mastocytosis.
• Participants undergoing desensitisation treatment to bee venom before the first visit.
• Participants being treatment with immunosuppressive medications. being treatment with immunosuppressive medications.

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead
• University of Plymouth: collaborator

Study Sites (1)

Derriford Hospital - University Hospitals Plymouth

Plymouth, Devon, PL65FP, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood-EDTA (Serum, PBMCs, Buffy coats, DNA \& RNA)

MeSH Terms

Conditions

Anaphylaxis

Interventions

Patch Tests; Hematologic Tests

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Claire Bethune

  University Hospitals Plymouth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Evely

CONTACT

441752431816; j.evely@nhs.net

Study Design

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

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 5, 2023
• Study Start: January 22, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

GB (1)