ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000333516

Ethics application status

Approved

Date submitted

22/07/2006

Date registered

7/08/2006

Date last updated

3/06/2009

Type of registration

Prospectively registered

Titles & IDs

Public title

Ant Venom Immunotherapy: Improving method and maintenance.

Scientific title

A randomised 2x2 comparison of ultra-rush with semi-rush initiation, and 50 microgram versus 100 microgram maintenance venom immunotherapy for preventing anaphylaxis in jack jumper ant venom allergic people.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Allergy (anaphylaxis) to the jack jumper ant (JJA)

Myrmecia pilosula.

Condition category

Condition code

Inflammatory and Immune System

Allergies

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Venom immunotherapy by subcutaneous injection; randomised 2 x 2 factorial design; ultra-rush (treatment initiation over 2 days) versus semi-rush (treatment initiation over 10 weeks), and 50 mcg versus 100 mcg maintenance dosing every three months for 3-5 years. A patient's choice arm is also available for part of the study where the patient may select either or both of initiation method and maintenance dose.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Not applicable

Control group

Active

Outcomes

Primary outcome [1]

Systemic reaction rates to immunotherapy during treatment initiation.

Timepoint [1]

3 visits (3 weeks) in ultra-rush and 10 visits (10 weeks) in semi-rush respectively.

Primary outcome [2]

Systemic reaction rates to sting challenge.

Timepoint [2]

After 12-15 months of maintenance therapy.

Secondary outcome [1]

Systemic reaction rates to immunotherapy during treatment initiation and to deliberate sting challenges in the patient choice arms.

Timepoint [1]

Definition of "treatment initiation" changed to 3 visits (3 weeks) in ultra-rush and 10 visits (10 weeks) in semi-rush respectively.

Secondary outcome [2]

Number of visits and total dose of venom extract up until sting challenge.

Timepoint [2]

12-15 months

Secondary outcome [3]

Time interval from treatment initiation to achieving 1 month, 2 month and 3 month dosing intervals.

Timepoint [3]

Measured over 12-15 months

Secondary outcome [4]

Reactions to accidental field stings over duration of treatment (3-5 years) and during long term follow up after stopping immunotherapy (10 years).

Timepoint [4]

10 years

Eligibility

Key inclusion criteria

Adults and children with a history of one or more systemic allergic reactions to a known or suspected JJA sting.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Negative intradermal skin and serum (RAST) tests for venom-specific IgE; pregnancy at time of treatment initiation; psychiatric illness rendering the patient unable to understand the study; severe cardiac or respiratory disease such that there is a high risk of decompensation to the mild-moderate allergic reactions that commonly occur with immunotherapy.

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)

Allocation of treatment initiation method is not concealed, however the dose given will be single-blind (treating staff will be aware of dose, but the patient will not be told).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random number table

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Factorial

Other design features

A "patient choice arm" is also provided so that patients may choose the initiation method and maintenance dose.

Phase

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

4/09/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

800

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Health and Human Services, Tasmanian Government

Address [1]

Hobart, Tasmania

Country [1]

Australia

Primary sponsor type

Government body

Name

Department of Health and Human Services, Tasmanian Government

Address

GPO Box 125
HOBART TAS 7001
AUSTRALIA

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Western Australia

Address [1]

Crawley, Western Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK -Royal Hobart Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/07/2006

Ethics approval number [1]

H0008934.

Ethics committee name [2]

HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK -Launceston General Hospital

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

21/07/2006

Ethics approval number [2]

H0008934.

Ethics committee name [3]

HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK -North West Regional Hospital

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

21/07/2006

Ethics approval number [3]

H0008934.

Summary

Brief summary

The objectives of this study are to improve the delivery of venom immunotherapy (VIT) by assessing the efficacy and safety of different approaches to venom immunotherapy, namely ultra-rush (ultra-rapid initiation over 2 days) versus semi-rush (initiation over 10 weeks) and half-dose (50 microgram) versus standard dose (100 microgram) maintenance treatment. 

Specific hypotheses are that: (i) ultra-rush initiation will be equivalent to outpatient semi-rush initiation in terms of allergic reaction rates to immunotherapy; (ii) A maintenance dose of 50 mcg will be as efficacious as a 100 mcg maintenance dose, and; (iii) VIT with both initiation methods and maintenance doses will have a sustained positive impact (reduced reaction risk) after cessation of VIT. 

The study will have important implications. If the different approaches are equivalent, we will be able to significantly reduce the amount of venom extract used and thus increase the number of patients that we can treat, given that our venom supplies are expensive and limited. 

Because it will be impossible to conceal treatment allocations, the different initiation methods will be unblinded. Maintenance doses will be single blinded (known to the treating doctor but not the patient) because of the significant day-to-day dose adjustments required during immunotherapy would make double-blinding difficult and potentially dangerous. 

The main outcome measures will be (1) the occurence of systemic allergic reactions to immunotherapy (safety of treatment) and (2) systemic allergic reactions to deliberate sting challenges and accidental stings (effectiveness of treatment)

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Associate Professor Simon G A Brown

Address

University of Western Australia
Discipline of Emergency Medicine
(M516) 2nd Floor R Block
QE11 Medical Centre
Nedlands WA 6009

Country

Australia

Phone

+61 419796678

Fax

simon.brown@uwa.edu.au

Contact person for scientific queries

Name

Associate Professor Simon G A Brown

Address

University of Western Australia
Discipline of Emergency Medicine
(M516) 2nd Floor R Block
QE11 Medical Centre
Nedlands WA 6009

Country

Australia

Phone

+61 419796678

Fax

simon.brown@uwa.edu.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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Factors influencing the quality of Myrmecia pilosula (Jack Jumper) ant venom for use in in vitro and in vivo diagnoses of allergen sensitization and in allergen immunotherapy.	2017	https://dx.doi.org/10.1111/cea.12987
Embase	Towards complete identification of allergens in Jack Jumper (Myrmecia pilosula) ant venom and their clinical relevance: An immunoproteomic approach.	2018	https://dx.doi.org/10.1111/cea.13224

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically