An observational study in Bee Sting, sponsored by University Hospital Plymouth 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 University Hospital Plymouth NHS Trust · Observational
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.
Beekeepers experience multiple stings each year many of whom (25-60%) become sensitised to bee (apis mellifera) venom through the production of IgE antibodies. However only a small proportion of the sensitised group go on to have anaphylaxis to bee venom. This study will investigate differences in T cell tolerance to bee venom in 3 groups by exploring factors that "protect" sensitised individuals from having anaphylactic reactions - meaning that despite being sensitised they are tolerant and do not react to subsequent stings.
T regulatory cell (Tregs) play a critical role in promoting immune tolerance to allergens and Treg generation has been shown to occur in bee venom allergic individuals following venom desensitisation therapy. Observations in sensitised tolerant (non-allergic) beekeepers (TB) suggest that exposure to venom through bee stings results in a similar increase in the frequencies of induced Tregs (iTregs). Helios negative induced Treg cells have also been suggested to contribute significantly to the establishment of immune tolerance in beekeepers. We will analyse the differences in Treg and Teffector (Teff) populations comparing sensitised beekeepers who are able to tolerate venom exposure (sensitised, tolerant beekeepers TB) with those beekeepers who do develop symptoms of systemic allergic reactions following bee sting (AB). A group of non-sensitised (NS) individuals will be recruited as a control population. We will perform RNA-seq to analyse the gene expression in Treg cells and Teff cells from all three groups. This will help to identify molecular targets that are involved in inducing the allergic reaction and also the genes that are involved in suppressing this reaction.
Considering the outcome of tolerance or anaphylaxis following bee stings, and the role of Treg and Teff cells in these processes, we will investigate the epigenetic regulations involved, which determine these cell's function. RNA-seq analysis will provide critical information about the genes involved in allergic reaction or in its suppression. DNA and histone modification analyses in the regulatory regions of these genes will help to better understand the underlying mechanism.
This project will investigate why some beekeepers who are sensitised to bee venom are able to tolerate bee stings, while in other sensitised individuals a bee sting can lead to life threatening anaphylaxis. This is not only of significance to beekeepers, but also has potential implications for the understanding of allergen tolerance in other allergic disease.
100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.
This study's planned enrollment of 120 is below the median of 137 across 48 observational studies indexed under Anaphylaxis.
Browse Anaphylaxis studies →University Hospital Plymouth NHS Trust is the lead sponsor of 53 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Group 1 inclusion criteria.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Skin prick test for bee venom
IgE/G and T cell tolerance studies
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.
Time frame: 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.
Time frame: 3 years
Molecular mechanism
(iii) To elucidate the molecular mechanism and the differences observed in (i) and (ii).
Time frame: 3 years
Epi regulation
(iiii) To elucidate the epigenetic regulation underpinning and the differences observed in (i) and (ii)
Time frame: 3 years
Sensitisation data- skin prick testing
To compare results of skin prick testing from the beginning and end of the beekeeping season.
Time frame: 3 years
Sensitisation data - specific IgE's in blood
To compare results of specific IgE's in blood from the beginning and end of the beekeeping season.
Time frame: 3 years
Started Jan 2024 (actual). Primary completion is estimated for Oct 2027, 44 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.
University Hospital Plymouth NHS Trust