Bee venom allergy desensitisation study

A single centre, randomised, controlled Phase 1/2 study of adults with bee venom allergy to evaluate the safety and efficacy of an Advax-adjuvanted bee venom desensitisation regime

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000379314

Acronym

BEE001

Enrollment

Registered

2008-08-01

Start date

2008-05-01

Completion date

2015-12-30

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will determine the most effective way to administer bee venom desensitisation therapy for people with serious life threatening bee venom allergy

Interventions

Bee venom desensitisation therapy administered per usual outpatient desensitisation therapy regimen involving weekly subcutaneous administrations of bee venom extract (0.001 microgram increasing in steps to 0.01, 0.1, 0.3, 1, 3, 6, 10, 15, 20, 25, 30, 35, 40, 45, 50, 70, then 100 microgram as tolerated) formulated with Advax adjuvant 10mg

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Known history of bee sting allergy

Exclusion criteria

Previous bee venom desensitisation therapy Women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device or mechanical barrier device. Pregnant or lactating women. Concurrent immunosuppressive therapy, including corticosteroids (with the exception of topically applied/inhaled steroids).

Outcome results