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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
Date last updated
20/04/2025
Titles & IDs
Public title
Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation
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Scientific title
Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation
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Secondary ID [1]
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NACE-004
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Universal Trial Number (UTN)
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Trial acronym
JAVELIN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Allergy
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Immunotherapy
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Venom Allergy
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Condition category
Condition code
Inflammatory and Immune System
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Allergies
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Presence of systemic reaction as assessed by the clinician
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Assessment method [1]
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This will be recorded by the clinician as YES or NO.
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Timepoint [1]
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Periprocedural
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Primary outcome [2]
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Severity of a clinically assessed systemic reaction measured by The Brown Grading Criteria
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Assessment method [2]
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The Brown Grading Criteria measures the severity of anaphylactic reactions by categorizing symptoms based on body systems affected and physiological impact. The tool uses a 3-point grading system: Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe. Higher scores indicate more severe anaphylactic reactions.
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Timepoint [2]
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Periprocedural
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Secondary outcome [1]
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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
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Assessment method [1]
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Trial specific questionnaire to be completed by the patient which captures information about any Jack Jumper Ant stings that the patient may have had since completion of Venom Immunotherapy Treatment and whether or not they experienced any type of reaction. If no sting was experienced only one question is required to be answered. If sting/s was experienced ten questions are asked including timing, symptoms, location, treatment and environment.
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Timepoint [1]
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At enrolment, 1-month post procedure and annually for 3-years
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Secondary outcome [2]
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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
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Assessment method [2]
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The Brown Grading Criteria measures the severity of anaphylactic reactions by categorizing symptoms based on body systems affected and physiological impact. The tool uses a 3-point grading system: Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe. Higher scores indicate more severe anaphylactic reactions.
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Timepoint [2]
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At enrolment, 1-month post procedure and annually for 3-years
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Secondary outcome [3]
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Change in attitude towards adrenaline auto-injectors as measured by the Adrenaline Auto-injector Questionnaire
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Assessment method [3]
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The Adrenaline Auto-injector Questionnaire measures patient attitudes and behaviors related to adrenaline auto-injectors as a 4 question survey. Current possession of an adrenaline auto-injector (yes/no), decision-making process regarding auto-injector maintenance (doctor advice, personal decision, or other influence), carrying/storage behaviors (ranging from constant carriage to unknown location), overall attitude assessment using a 7-point scale regarding the advantages and disadvantages of carrying an auto-injector where the minimum score is 1 and the maximum score is 7. A lower score indicates a better outcome.
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Timepoint [3]
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At enrolment, 1-month post procedure and annually for 3-years
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Secondary outcome [4]
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Change in quality of life as measured by the Vespid Quality of Life Questionnaire
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Assessment method [4]
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An adapted insect allergy specific health-related quality of life questionnaire. 14 questions with 7 response options giving a score of 1-7, with lower scores representing a higher quality of life.
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Timepoint [4]
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At enrolment, 1-month post procedure and annually for 3-years
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Secondary outcome [5]
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Change in quality of life measured using the Hospital Anxiety and Depression Scale
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Assessment method [5]
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Developed to assess depression and anxiety. Each response ranges from 0 to 3, the 14 responses are added to yield a total score between 0 and 42. Higher scores indicate higher severity of anxiety and depression.
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Timepoint [5]
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At enrolment, 1-month post procedure and annually for 3-years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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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
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/09/2025
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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
1/10/2029
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,TAS,VIC
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [3]
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Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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7000 - Hobart
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Recruitment postcode(s) [3]
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3168 - Clayton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Jack Jumper ant (JJA) venom allergy is a uniquely Australian medical condition. It is the leading cause of venom allergy and affects up to three per cent of the population. 70 percent of people with JJA allergy will have another reaction on a repeat sting and this sensitivity appears to persist for many years. Venom immunotherapy (VIT) has been shown to be a safe and effective treatment in the prevention of severe systemic allergic reactions (anaphylaxis) to future stings. It is currently offered to patients as standard care in Tasmania, South Australia and Victoria. However, whilst JJA VIT has been used for many years, there is a lack of evidence on the long-term benefit of the treatment and how it impacts patient quality of life. This trial will offer patients who have completed a JJA VIT program (between 3 and \< 6-years duration) and have been off-treatment for at least 18-months and \< 5 years, to have a supervised JJA sting challenge and blood test to assess their JJA venom tolerance level. It will also ask them to complete a set of questionnaires at different timepoints to obtain a history of their exposure and reactions to JJA stings outside of the hospital setting (field stings), and to measure the impact of the completed VIT and knowledge of their sting challenge outcome on their quality of life and their behaviours around auto-injectors. These measures will be used to explore the long-term effectiveness of JJA VIT and the impact of a sting challenge post VIT on a patient's quality of life.
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Trial website
https://clinicaltrials.gov/study/NCT06935890
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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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Adriana Le, MBBS FRACP
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Address
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Royal Hobart Hospital
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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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National Allergy Centre of Excellence
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Address
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Country
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Phone
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61 3 99366752
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
After the data has been cleaned and database has been locked, the de-identified data and if consented, personal identifying information, will be shared to National Allergy Centre of Excellence (NACE) Allergy BioRepository via a safe and secure mechanism, for storage and use in future allergy research.
Supporting document/s available: Study protocol, Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
At 6 months post the commencement of JAVELIN, de-identified data, encrypted with NACE unique identifier codes and secure linkage key tokens, will be transferred to the ALBI platform, for storage, integration and sharing for future HREC-approved allergy research purposes. Data once in ALBI remains indefinitely.
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Available to whom?
ALBI will only provide researchers with non-identifiable information following the Scientific Access Framework. Researchers need to apply for access to ALBI data. Once approved, data will be made available to the researchers by logging in through a secure research platform. Researchers will not have access to the entire ALBI system as they will be provided extracts from ALBI of non-identifiable information related to their specific request and approval. Information will only be shared with ethically approved future allergy research studies.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.nace.org.au/
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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
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