Honey Bee Venom Immunotherapy Randomised Safety Study, Victoria

Trial Review

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Registration number

ACTRN12626000517370 Ethics application status

Approved Date submitted

16/03/2026 Date registered

28/04/2026 Date last updated

28/04/2026 Date data sharing statement initially provided

28/04/2026 Type of registration

Prospectively registered
Titles & IDs Public title Initiating Honey Bee Venom Immunotherapy at the 100-µg Maintenance Dose versus Ultrarush Up-dosing: A Randomised Pilot Safety Study Query! Scientific title 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 Query! Additional trial identifiers [1] 316743 0 None Query! Universal Trial Number (UTN) Query! Trial acronym FLASH HBV-VIT Query! Related trial records Query!
Health condition Health condition(s) studied: Honey Bee Sensitivity (Allergy) 341026 0 Query! Condition category Condition code Inflammatory and Immune System 337170 337170 0 0 Query! Allergies Query!

Intervention/exposure Study type Interventional Query! Description of the intervention or exposure 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. Query! Intervention code [1] 333469 0 Treatment: Drugs Query! Intervention code [2] 333617 0 Prevention Query! Description of the comparator or control Honey Bee (A. mellifera) venom immunotherapy initiation for patients who are sensitised to honey bees and undergoing venom immunotherapy will commence the immunotherapy treatment using the Ultra rush protocol; Week 0(Day 0): 0.1 µg, 1 µg, 10 µg, 20 µg, 30 µg, 40 µg (each 30 minutes apart), week 2(Day 15): 50 µg then 50 µg (30 minutes apart), week 7(Day 43): 100 µg (single dose), Week 12: 100 µg (single dose). Additional blood tests to assess immune function will be taken before and after each dose of treatment to understand immune function.
Query! Control group Active Query!
Outcomes Primary outcome [1] 344737 0 Compare the incidence and severity of systemic reactions (Brown grade 1–3) occurring during the venom Immunotherapy (VIT) induction/up-dosing period between the induction cohorts. This will be assessed as a composite outcome. Query! Timepoint [1] 344737 0 Baseline and each immunotherapy visit during the 12 week induction period. Query! Secondary outcome [1] 459053 0 Compare occurrence of large local reaction rates (=10 cm) and trajectories over the induction period between the induction cohorts. This will be assessed as a composite outcome. Query! Timepoint [1] 459053 0 Baseline and each immunotherapy visit during the 12 week induction period. Query! Secondary outcome [2] 459064 0 Quantify immunologic changes (e.g. HBV-specific sIgE/sIgG4) Query! Timepoint [2] 459064 0 Screening and week 12 of the induction period Query! Secondary outcome [3] 459065 0 Investigate blood tryptase as a biomarkers of reactivity Query! Timepoint [3] 459065 0 Week 0 and each induction visit during the 12 week induction period Query! Secondary outcome [4] 459066 0 Evaluate late-phase symptoms difference between induction cohorts.
Such as rash, itchiness, abdominal symptoms Query! Timepoint [4] 459066 0 Week 0 and each induction visit during the 12 week induction period Query! Secondary outcome [5] 459067 0 Evaluate quality of life (QoL) outcome measures in induction of honey bee venom - venom immunotherapy (HBV-VIT) Query! Timepoint [5] 459067 0 Week 0 and each induction visit during the 12 week induction period Query!
Eligibility Key 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
Query! Minimum age 18 Years Query! Query! Maximum age No limit Query! Query! Sex Both males and females Query! Can healthy volunteers participate? No Query! Key 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.
Query!
Study design Purpose of the study Treatment Query! Allocation to intervention Randomised controlled trial Query! Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures) central randomisation by computer Query! Methods used to generate the sequence in which subjects will be randomised (sequence
generation) Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) Query! Masking / blinding Open (masking not used) Query! Who is / are masked / blinded?

Query! Query! Query! Query! Intervention assignment Parallel Query! Other design features Query! Phase Phase 0 Query! Type of endpoint/s Safety/efficacy Query! Statistical methods / analysis Query!
Recruitment Recruitment status Not yet recruiting Query! Date of first participant enrolment Anticipated 30/04/2026 Query! Actual Query! Date of last participant enrolment Anticipated 31/03/2027 Query! Actual Query! Date of last data collection Anticipated 30/07/2027 Query! Actual Query! Sample size Target 24 Query! Accrual to date Query! Final Query! Recruitment in Australia Recruitment state(s) VIC Query! Recruitment hospital [1] 29260 0 The Royal Women's Hospital - Parkville Query! Recruitment hospital [2] 29261 0 Monash Medical Centre - Clayton campus - Clayton Query! Recruitment postcode(s) [1] 45569 0 3052 - Parkville Query! Recruitment postcode(s) [2] 45570 0 3168 - Clayton Query!
Funding & Sponsors Funding source category [1] 321346 0 Hospital Query! Name [1] 321346 0 The Royal Melbourne Hospital Query! Country [1] 321346 0 Australia Query! Funding source category [2] 321565 0 Government body Query! Name [2] 321565 0 Australian Government Pharmaceutical Benefits Scheme (PBS) Query! Country [2] 321565 0 Australia Query! Primary sponsor type Hospital Query! Name The Royal Melbourne Hospital Query! Address Query! Country Australia Query! Secondary sponsor category [1] 324084 0 None Query! Name [1] 324084 0 Query! Address [1] 324084 0 Query! Country [1] 324084 0 Query! Other collaborator category [1] 283877 0 Other Collaborative groups Query! Name [1] 283877 0 The Walter and Eliza Hall Institute Query! Address [1] 283877 0 Query! Country [1] 283877 0 Australia Query!
Ethics approval Ethics application status Approved Query! Ethics committee name [1] 319882 0 The Royal Melbourne Hospital Human Research Ethics Committee Query! Ethics committee address [1] 319882 0 https://www.thermh.org.au/research/researchers/ethics Query! Ethics committee country [1] 319882 0 Australia Query! Date submitted for ethics approval [1] 319882 0 26/11/2025 Query! Approval date [1] 319882 0 29/01/2026 Query! Ethics approval number [1] 319882 0 Query!
Summary 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). Query! Trial website Query! Trial related presentations / publications Query! Public notes Query!
Contacts Principal investigator Name 148710 0 A/Prof Kymble Spriggs Query! Address 148710 0 Department of Clinical Immunology and Allergy, The Royal Melbourne Hospital, 4W, 300 Grattan St Parkville, Victoria 3050 Query! Country 148710 0 Australia Query! Phone 148710 0 +61412356560 Query! Fax 148710 0 Query! Email 148710 0 [email protected] Query! Contact person for public queries Name 148711 0 Kymble Spriggs Query! Address 148711 0 Department of Clinical Immunology and Allergy, The Royal Melbourne Hospital,4W, 300 Grattan St, Parkville, VIC 3050 Query! Country 148711 0 Australia Query! Phone 148711 0 +61393427191 Query! Fax 148711 0 Query! Email 148711 0 [email protected] Query! Contact person for scientific queries Name 148712 0 Kymble Spriggs Query! Address 148712 0 Department of Clinical Immunology and Allergy, The Royal Melbourne Hospital, 4W, 300 Grattan St Parkville, VIC 3050 Query! Country 148712 0 Australia Query! Phone 148712 0 +61393427191 Query! Fax 148712 0 Query! Email 148712 0 [email protected] Query!
Data sharing statement Will the study consider sharing individual participant data? No
No IPD sharing reason/comment: Study outcomes will be published in peer review journals. Data will be de-identified to protect participants identity.

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