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Trial registered on ANZCTR


Registration number
ACTRN12608000379314
Ethics application status
Approved
Date submitted
19/06/2008
Date registered
1/08/2008
Date last updated
1/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bee venom allergy desensitisation study
Scientific title
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
Universal Trial Number (UTN)
Trial acronym
BEE001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bee venom allergy 3284 0
Condition category
Condition code
Inflammatory and Immune System 3447 3447 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 3022 0
Treatment: Other
Comparator / control treatment
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)
Control group
Active

Outcomes
Primary outcome [1] 4339 0
Bee venom desensitisation as assessed by bee venom skin challenge test
Timepoint [1] 4339 0
3, 6, 9, and 12 months after start of Bee venom desensitisation therapy
Secondary outcome [1] 7381 0
Safety assessment as assessed by frequency of local (i.e injection site reactions) and systemic adverse events (e.g. fever, myalgia, fatigue) and serious adverse events (e.g. anaphylaxis, hospitalisation)
Timepoint [1] 7381 0
12 months

Eligibility
Key inclusion criteria
Known history of bee sting allergy
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3495 0
Self funded/Unfunded
Name [1] 3495 0
Country [1] 3495 0
Primary sponsor type
Commercial sector/Industry
Name
Vaxine pty Ltd
Address
Flinders Medical Centre
Adelaide 5042
Country
Australia
Secondary sponsor category [1] 3138 0
None
Name [1] 3138 0
Address [1] 3138 0
Country [1] 3138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5532 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 5532 0
Ethics committee country [1] 5532 0
Australia
Date submitted for ethics approval [1] 5532 0
Approval date [1] 5532 0
Ethics approval number [1] 5532 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28679 0
Address 28679 0
Country 28679 0
Phone 28679 0
Fax 28679 0
Email 28679 0
Contact person for public queries
Name 11836 0
Assoc. Prof. Bob Heddle
Address 11836 0
Flinders Medical Centre
Adelaide 5042
Country 11836 0
Australia
Phone 11836 0
0882044572
Fax 11836 0
Email 11836 0
bob.heddle@fmc.sa.gov.au
Contact person for scientific queries
Name 2764 0
Assoc. Prof. Bob Heddle
Address 2764 0
Flinders Medical Centre
Adelaide 5042
Country 2764 0
Australia
Phone 2764 0
0882044572
Fax 2764 0
Email 2764 0
bob.heddle@fmc.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.