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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
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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
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Universal Trial Number (UTN)
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Trial acronym
BEE001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bee venom allergy
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Condition category
Condition code
Inflammatory and Immune System
3447
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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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)
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Control group
Active
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Outcomes
Primary outcome [1]
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Bee venom desensitisation as assessed by bee venom skin challenge test
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Assessment method [1]
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Timepoint [1]
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3, 6, 9, and 12 months after start of Bee venom desensitisation therapy
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Secondary outcome [1]
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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)
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Assessment method [1]
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Timepoint [1]
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12 months
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Eligibility
Key inclusion criteria
Known history of bee sting allergy
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/01/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
Commercial sector/Industry
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Name
Vaxine pty Ltd
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Address
Flinders Medical Centre
Adelaide 5042
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Flinders Clinical Research Ethics Committee
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Ethics committee address [1]
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Flinders Medical Centre
Adelaide 5042
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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Ethics approval number [1]
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Summary
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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Assoc. Prof. Bob Heddle
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Address
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Flinders Medical Centre
Adelaide 5042
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Country
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Australia
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Phone
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0882044572
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Assoc. Prof. Bob Heddle
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Address
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Flinders Medical Centre
Adelaide 5042
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Country
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Australia
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Phone
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0882044572
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Fax
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Email
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[email protected]
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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
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
3905
Plain language summary
No
Background. Allergic reactions to Hymenoptera inse...
[
More Details
]
4227
Study results article
Yes
Heddle, B, Smith A, Woodman R, Hissaria P, Petrovs...
[
More Details
]
82910-(Uploaded-30-12-2019-17-27-13)-Journal results publication.pdf
Documents added automatically
No additional documents have been identified.
Download to PDF