Initiating Honey Bee Venom Immunotherapy at the 100-µg Maintenance Dose versus Ultrarush Up-dosing: A Randomised Pilot Safety Study
Initiating Honey Bee Venom Immunotherapy at the 100-µg Maintenance Dose versus Ultrarush Up-dosing: A Randomised Pilot Safety Study in participants sensitised to honey bee venom
The Royal Melbourne Hospital
24 participants
Apr 30, 2026
Interventional
Conditions
Summary
Honey bee venom immunotherapy (VIT) is an incredibly effective treatment with efficacy reported to be around 95% at preventing severe allergic reactions. This translates not only to a mortality benefit in those with severe allergy, but also obviating the downstream quality of life morbidity of living with the potential for such a reaction and restrictions to participation thereof. Despite the clear benefits, conventional initiation/build-up strategies can be time-consuming. Ultrarush protocols deliver multiple escalating doses within a single day to reach higher doses quickly, while a “100-µg maintenance-dose initiation” strategy may simplify scheduling and patient participation by starting directly at the target dose. This pilot randomised study compares the safety of these two induction strategies in adults with confirmed honey bee venom allergy, focusing on systemic reactions graded by the “Brown” method and early immunologic changes (e.g. sIgE/sIgG4).
Eligibility
Inclusion Criteria5
- Adults > 18 years of age
- History of systemic reaction to field honey bee sting graded by Brown scale 1–3
- Deemed appropriate for honey bee VIT by an Immunologist
- HBV-specific IgE greated than or equal to 0.35 kUA/L
- Able and willing to attend induction visits and provide written consent
Exclusion Criteria8
- History of near-fatal sting reactions or clinician-judged unacceptable risk
- Confirmed Mastocytosis/clonal mast cell disease
- Elevated tryptase >8.0, with positive D816V
- Severe cardiopulmonary disease or uncontrolled asthma (defined as rescue medication > 3 times/week, or ACQ >1.5)
- Immune deficiency, autoimmune disease, malignancy, or severe renal failure
- Pregnancy and/or breast feeding
- Use of ß-blockers or immunosuppressants; use of biologics for the treatment of allergic disease.
- Any other medical history that in the judgment of the investigator may compromise the safety of the participant.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Honey Bee (A. mellifera) venom immunotherapy initiation for patients who are sensitised to honey bees and undergoing subcutaneous venom immunotherapy in the hospital clinic. Participants will commenced the immunotherapy treatment at the maintenance dose (100mcg) (single subcutaneous injection) at week 0, week 4, week 8 and week 12. Participants will be monitored for safety and symptoms as per standard of care by experienced allergy physicians and nurses. Additional blood tests to assess immune function will be taken before and after each dose of treatment to understand immune function.
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12626000517370