Not Yet RecruitingEarly Phase 1ACTRN12626000517370

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


Sponsor

The Royal Melbourne Hospital

Enrollment

24 participants

Start Date

Apr 30, 2026

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

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.

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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 commence

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)

The Royal Women's Hospital - Parkville

VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

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ACTRN12626000517370