AllergyPhase 4JAVELINNCT06935890
Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation
A Phase 4 study testing Jack Jumper Ant Venom Immunotherapy in people with Allergy and Immunotherapy, run by Murdoch Childrens Research Institute at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy, Immunotherapy, Venom Allergy
- What is being tested?
- Jack Jumper Ant Venom Immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesAustralia
- Study dates
- 25 Nov 2025to Oct 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed a continuous program of JJA VIT of between 3 and < 6 years duration.
- Have ceased JJA VIT for ≥ 18 months but < 5 years.
- Have the ability to provide informed consent.
Who cannot join
- Any person < 18 years.
- Any adult (≥ 18 years) who has not completed a continuous JJA VIT program of duration between 3 and < 6 years.
- 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.
- 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.
- Unable to understand study requirements and provide informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
National Allergy Centre of Excellence, 61 3 99366752, nace@mcri.edu.au
Carlo Yuson, MD FRACP
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
National Allergy Centre of Excellence, 61 3 99366752, nace@mcri.edu.au
Kymble Spriggs, MBBS MPH FRACP FRCP FAAAAI
- Recruiting
Royal Hobart Hospital
Hobart, Tasmania, 7000
National Allergy Centre of Excellence, 61 3 99366752, nace@mcri.edu.au
Troy Wanandy, PhD
About this study
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.
Read more
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.
Read the detailed description
This will be a prospective, multicentre, phase 4 clinical trial examining the long-term effectiveness (measured by response to an in-hospital JJA sting challenge, primary outcome) and impact on quality of life of JJA VIT involving 3 Australian tertiary hospital sites offering this treatment - Royal Hobart Hospital, Royal Adelaide Hospital and Monash Medical Centre.
Patients who have completed their JJA VIT (between 3 and <6 years duration) at one of the 3 sites and off-treatment for at least 18 months and < 5 years, will be invited to participate in the trial by their original treating site. A research team member will obtain informed e-consent and a booking for an in-clinic JJA sting challenge will be allocated. For all consented participants, quality of life (QoL), anxiety and depression scores, history of field sting reactions since treatment completion and attitudes toward adrenaline autoinjector carriage/usage will be collected via questionnaire at trial enrolment, sting challenge, 1-month post sting challenge and annually for 3-years. A blood sample will be collected immediately prior to the sting challenge at the in-clinic appointment. Participants will also be asked to consent to access retrospective data related to their completed JJA VIT course from their hospital clinical records.
Optional consents will also be sought from each participant for the collection of an extra tube of blood with the serum biobanked for future analysis, and the inclusion of their data in the National Allergy BioRepository (ALBI).
- Conditions
- Allergy, Immunotherapy, Venom Allergy
- Being tested
- Jack Jumper Ant Venom Immunotherapy
- Keywords
- Jack Jumper Ant, Venom Immunotherapy, Sting challenge, VIT
- Medical subject headings
- Hypersensitivity, Venom Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jack Jumper Ant Venom ImmunotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants who have completed Jack Jumper Ant Venom Immmunotherapy treatment | Experimental | Not described Receives: Other: Jack Jumper Ant Venom Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a systemic reaction to JJA live ant sting challenge
This will be assessed by the clinician and recorded as YES or NO.
Measured: Periprocedural
Severity of a clinically assessed systemic reaction measured by The Brown Grading Criteria
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.
Measured: Periprocedural
Secondary outcomes (5)
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
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.
Measured: At enrolment, 1-month post procedure and annually for 3-years
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
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.
Measured: At enrolment, 1-month post procedure and annually for 3-years
Change in attitude towards adrenaline auto-injectors as measured by the Adrenaline Auto-injector Questionnaire
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.
Measured: At enrolment, 1-month post procedure and annually for 3-years
Change in quality of life as measured by the Vespid Quality of Life Questionnaire
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.
Measured: At enrolment, 1-month post procedure and annually for 3-years
Change in quality of life measured using the Hospital Anxiety and Depression Scale
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.
Measured: At enrolment, 1-month post procedure and annually for 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start25 Nov 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana Le, MBBS FRACP, Principal investigator, Royal Hobart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935890
- Sponsor's protocol ID
- NACE-004
- Acronym
- JAVELIN
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation
- ClinicalTrials.gov ID
- NCT06935890
- Acronym / sponsor ID
- JAVELIN / NACE-004
- Conditions
- Allergy, Immunotherapy, Venom Allergy
- Keywords
- Jack Jumper Ant, Venom Immunotherapy, Sting challenge, VIT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a prospective, multicentre, phase 4 clinical trial examining the long-term effectiveness (measured by response to an in-hospital JJA sting challenge, primary outcome) and impact on quality of life of JJA VIT involving 3 Australian tertiary hospital sites offering this treatment - Royal Hobart Hospital, Royal Adelaide Hospital and Monash Medical Centre.
Patients who have completed their JJA VIT (between 3 and <6 years duration) at one of the 3 sites and off-treatment for at least 18 months and < 5 years, will be invited to participate in the trial by their original treating site. A research team member will obtain informed e-consent and a booking for an in-clinic JJA sting challenge will be allocated. For all consented participants, quality of life (QoL), anxiety and depression scores, history of field sting reactions since treatment completion and attitudes toward adrenaline autoinjector carriage/usage will be collected via questionnaire at trial enrolment, sting challenge, 1-month post sting challenge and annually for 3-years. A blood sample will be collected immediately prior to the sting challenge at the in-clinic appointment. Participants will also be asked to consent to access retrospective data related to their completed JJA VIT course from their hospital clinical records.
Optional consents will also be sought from each participant for the collection of an extra tube of blood with the serum biobanked for future analysis, and the inclusion of their data in the National Allergy BioRepository (ALBI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants who have completed Jack Jumper Ant Venom Immmunotherapy treatment | Experimental | Other: Jack Jumper Ant Venom Immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completed a continuous program of JJA VIT of between 3 and < 6 years duration.
- Have ceased JJA VIT for ≥ 18 months but < 5 years.
- Have the ability to provide informed consent.
Key exclusion criteria (5 listed)
- Any person < 18 years.
- Any adult (≥ 18 years) who has not completed a continuous JJA VIT program of duration between 3 and < 6 years.
- 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.
- 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.
- Unable to understand study requirements and provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jack Jumper Ant Venom ImmunotherapyJack 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. | Other | Participants who have completed Jack Jumper Ant Venom Immmunotherapy treatment |
Primary outcome
Presence of a systemic reaction to JJA live ant sting challenge
Time frame: Periprocedural
This will be assessed by the clinician and recorded as YES or NO.
Severity of a clinically assessed systemic reaction measured by The Brown Grading Criteria
Time frame: Periprocedural
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.
5 secondary outcomes
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
Time frame: At enrolment, 1-month post procedure and annually for 3-years
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
Time frame: At enrolment, 1-month post procedure and annually for 3-years
Change in attitude towards adrenaline auto-injectors as measured by the Adrenaline Auto-injector Questionnaire
Time frame: At enrolment, 1-month post procedure and annually for 3-years
Change in quality of life as measured by the Vespid Quality of Life Questionnaire
Time frame: At enrolment, 1-month post procedure and annually for 3-years
Change in quality of life measured using the Hospital Anxiety and Depression Scale
Time frame: At enrolment, 1-month post procedure and annually for 3-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- JAVELIN trial informationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adriana Le, MBBS FRACP principal investigator
Royal Hobart Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jack Jumper Ant Venom Immunotherapy in people with Allergy and Immunotherapy, run by Murdoch Childrens Research Institute at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact National Allergy Centre of Excellence (61 3 99366752, nace@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a systemic reaction to JJA live ant sting challenge (time frame: Periprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.