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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06935890




Registration number
NCT06935890
Ethics application status
Date submitted
2/04/2025
Date registered
20/04/2025

Titles & IDs
Public title
Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation
Scientific title
Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation
Secondary ID [1] 0 0
NACE-004
Universal Trial Number (UTN)
Trial acronym
JAVELIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergy 0 0
Immunotherapy 0 0
Venom Allergy 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Jack Jumper Ant Venom Immunotherapy

Experimental: Participants who have completed Jack Jumper Ant Venom Immmunotherapy treatment -


Other interventions: Jack Jumper Ant Venom Immunotherapy
Jack Jumper Ant Venom Immunotherapy involves injections, under the skin, of gradually increasing doses of insect venom. The treatment is usually between 3-\<6 years duration. Participants will have completed this treatment at least 18 months prior to their enrolment in this trial.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of systemic reaction as assessed by the clinician
Timepoint [1] 0 0
Periprocedural
Primary outcome [2] 0 0
Severity of a clinically assessed systemic reaction measured by The Brown Grading Criteria
Timepoint [2] 0 0
Periprocedural
Secondary outcome [1] 0 0
Change in presence of a systemic reaction to a field sting following cessation of Jack Jumper Ant Venom Immunotherapy as reported by the patient on a trial-specific questionnaire
Timepoint [1] 0 0
At enrolment, 1-month post procedure and annually for 3-years
Secondary outcome [2] 0 0
Change in severity of a systemic reaction to a field sting following cessation of Jack Jumper Ant Venom Immunotherapy as measured by The Brown Grading Criteria
Timepoint [2] 0 0
At enrolment, 1-month post procedure and annually for 3-years
Secondary outcome [3] 0 0
Change in attitude towards adrenaline auto-injectors as measured by the Adrenaline Auto-injector Questionnaire
Timepoint [3] 0 0
At enrolment, 1-month post procedure and annually for 3-years
Secondary outcome [4] 0 0
Change in quality of life as measured by the Vespid Quality of Life Questionnaire
Timepoint [4] 0 0
At enrolment, 1-month post procedure and annually for 3-years
Secondary outcome [5] 0 0
Change in quality of life measured using the Hospital Anxiety and Depression Scale
Timepoint [5] 0 0
At enrolment, 1-month post procedure and annually for 3-years

Eligibility
Key inclusion criteria
Eligibility criteria

- Any adult (= 18 years) who has completed a JJA VIT program at one of the three participating sites.



1. Completed a continuous program of JJA VIT of between 3 and < 6 years duration.
2. Have ceased JJA VIT for = 18 months but < 5 years.
3. Have the ability to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any person < 18 years.
2. Any adult (= 18 years) who has not completed a continuous JJA VIT program of duration between 3 and < 6 years.
3. Any adult (= 18 years) who has completed a continuous JJA VIT program of duration between 3 and < 6 years but ceased JJA VIT < 18 months or > 5 years ago.
4. Any person who has a medical condition, that in the opinion of the investigator, may place them at increased risk if they were to have a sting challenge.
5. Unable to understand study requirements and provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2029
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,TAS,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Adriana Le, MBBS FRACP
Address 0 0
Royal Hobart Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
National Allergy Centre of Excellence
Address 0 0
Country 0 0
Phone 0 0
61 3 99366752
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06935890