None listed
Conditions
Brief 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).
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 f
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.
Sponsors
The Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults > 18 years of age 2. History of systemic reaction to field honey bee sting graded by Brown scale 1–3 3. Deemed appropriate for honey bee VIT by an Immunologist 4. HBV-specific IgE greated than or equal to 0.35 kUA/L 5. Able and willing to attend induction visits and provide written consent
Exclusion criteria
1. History of near-fatal sting reactions or clinician-judged unacceptable risk 2. Confirmed Mastocytosis/clonal mast cell disease 3. Elevated tryptase >8.0, with positive D816V 4. Severe cardiopulmonary disease or uncontrolled asthma (defined as rescue medication > 3 times/week, or ACQ >1.5) 5. Immune deficiency, autoimmune disease, malignancy, or severe renal failure 6. Pregnancy and/or breast feeding 7. Use of ß-blockers or immunosuppressants; use of biologics for the treatment of allergic disease. 8. Any other medical history that in the judgment of the investigator may compromise the safety of the participant.
Outcome results
None listed