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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03066986




Registration number
NCT03066986
Ethics application status
Date submitted
20/02/2017
Date registered
1/03/2017

Titles & IDs
Public title
Study of Sting Challenge and Serological Responses to Jack Jumper Venom Immunotherapy With Inulin as Adjuvant (Jumpvax)
Scientific title
A Dose Ranging Study of Sting Challenge and Specific lgE, and IgG4 Responses to Jack Jumper Ant (JJA) [Myrmecia Pilosula] Venom Immunotherapy (VIT) With and Without Delta-inulin as an Adjuvant.
Secondary ID [1] 0 0
CT-2015-CTN-03308-1 v2
Secondary ID [2] 0 0
CALHN Ref No. R20151007
Universal Trial Number (UTN)
Trial acronym
Jumpvax
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ant Sting 0 0
Immunotherapy 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Delta-inulin
Treatment: Other - Dose finding comparison

Experimental: 25mcg JJA venom - Subjects will receive semi-rush JJA VIT (without delta-inulin) aiming to achieve a maintenance dose of JJA venom of 25mcg (dose finding comparison).

Experimental: 25mcg JJA venom + 5mg delta-inulin - Subjects will receive semi-rush JJA VIT with delta-inulin (at a fixed dose of 5 mg with each dose of venom) aiming to achieve a maintenance dose of JJA venom of 25mcg (dose finding comparison, adjuvant comparison).

Active comparator: 50mcg JJA venom - Subjects will receive semi-rush JJA VIT (without delta-inulin) aiming to achieve a maintenance dose of JJA venom of 50mcg, ie. the current standard of care.

Experimental: 50mcg JJA venom + 5mg delta-inulin - Subjects will receive semi-rush JJA VIT with delta-inulin (at a fixed dose of 5 mg with each dose of venom) aiming to achieve a maintenance dose of JJA venom of 50mcg (adjuvant comparison).


Treatment: Drugs: Delta-inulin
Addition of adjuvant, delta-inulin to JJA VIT regime, to determine if this will allow lower doses and shorter regimes to promote protective responses, reducing costs and morbidity of JJA VIT.

Treatment: Other: Dose finding comparison
Define minimum effective maintenance dose (50mcg vs 25mcg). In "real world" sting challenges after 12 months of JJA VIT objective systemic reaction rates after 50 and 100 mcg maintenance doses respectively 14/130 and 12/126 subjects vs reaction rates to stings in similar subjects without JJA VIT 70-76%. Venom delivery in sting likely \<20mcg. Therefore minimum effective maintenance dose not yet defined.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response to in-hospital JJA sting following 12 months of maintenance treatment
Timepoint [1] 0 0
15 months
Primary outcome [2] 0 0
Specific IgG4 responses to JJA venom during treatment
Timepoint [2] 0 0
18 months
Primary outcome [3] 0 0
Specific IgE responses to JJA venom during treatment
Timepoint [3] 0 0
18 months
Secondary outcome [1] 0 0
Changes in VST to JJA venom during treatment
Timepoint [1] 0 0
15 months
Secondary outcome [2] 0 0
Adverse reactions to JJA venom immunotherapy
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Incidental reactions to field stings during JJA venom immunotherapy
Timepoint [3] 0 0
18 months

Eligibility
Key inclusion criteria
* Previous immediate systemic allergic reaction to definite or possible JJA sting.
* Venom-specific lgE response to JJA venom (by intradermal skin testing or serological analysis).
* Age between 18 and 65 years at the time of starting treatment.
* Gives informed consent, including acknowledgement that any protection from JJA sting anaphylaxis may be short lived and that JJA VIT and in particular, JJA sting challenges have the potential to cause systemic allergic reactions, including anaphylaxis.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant (women of child-bearing age will have a urine pregnancy test on first day of treatment) or intended pregnancy during treatment.
* Beta-blocker, ACE-inhibitor or mono-amine oxidase therapy for any reason.
* Unstable heart disease.
* Poorly controlled lung disease; defined as being severe enough to cause breathlessness on mild or moderate exertion, i.e. unable to walk up a modest incline.
* Any other chronic or severe medical condition which puts the patient at increased risk if they participated in this study in the investigators opinion.
* Previous JJA VIT, any ongoing immunotherapy or use of immunosuppressive drugs.
* Raised baseline mast cell tryptase

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?
The people receiving the treatment/s


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

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network Incorporated
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Vaxine Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Pravin Hissaria, FRACP FRCPA
Address 0 0
Royal Adelaide Hospital and SA Pathology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD will be shared with collaborating institutions/organisations, specifically Royal Hobart Hospital JJA Program and Vaxine Pty Ltd, Flinders Medical Centre. We are prepared to share de-identified data with other researchers. We do not expect any substantive results to be available until February 2018. Enquries for obtaining data should be directed to the primary investigators P Hissaria or TA Le.

Supporting document/s available: Study protocol, Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Primary and secondary outcome data to be shared with collaborators until end of study (end 2021)
Available to whom?
Data access will be limited to collaborators and data safety monitor
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03066986