A Phase 4 interventional study of Jack Jumper Ant Venom Immunotherapy in Allergy, Immunotherapy and Venom Allergy, sponsored by Murdoch Childrens Research Institute. Recruiting at 3 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Murdoch Childrens Research Institute · Phase 4, Interventional, and Treatment
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.
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).
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 100 is above the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligibility criteria
- Any adult (≥ 18 years) who has completed a JJA VIT program at one of the three participating sites.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: 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.
Presence of a systemic reaction to JJA live ant sting challenge
This will be assessed by the clinician and recorded as YES or NO.
Time frame: 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.
Time frame: Periprocedural
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.
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
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.
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
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.
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
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.
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
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.
Time frame: At enrolment, 1-month post procedure and annually for 3-years
Plan to share: 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.
Supporting information: Study protocol, Clinical study report, Analytic code
Time frame: 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.
Access criteria: 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.
Data sharing details ↗ · www.nace.org.au
Started Nov 2025 (actual). Primary completion is estimated for Oct 2029, 47 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Murdoch Childrens Research Institute