Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation

NCT06935890 | Recruiting Phase 4

• 1 other identifier: NACE-004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Immunotherapy; Venom Allergy; Allergy

Keywords

Jack Jumper Ant; Venom Immunotherapy; Sting challenge; VIT

Outcome Measures

Primary Outcomes (2)

• Presence of systemic reaction as assessed by the clinician

  This will be recorded by the clinician as YES or NO.

  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.

  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

  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

  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

  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

  At enrolment, 1-month post procedure and annually for 3-years

• Change in quality of life measured using the Hospital Anxiety and Depression Scale

  At enrolment, 1-month post procedure and annually for 3-years

Study Arms (1)

Participants who have completed Jack Jumper Ant Venom Immmunotherapy treatment

EXPERIMENTAL

Other: Jack Jumper Ant Venom Immunotherapy

Interventions

Jack Jumper Ant Venom Immunotherapy OTHER

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.

Participants who have completed Jack Jumper Ant Venom Immmunotherapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (3)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

RECRUITING

Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

Related Links

• JAVELIN trial information

MeSH Terms

Conditions

Hypersensitivity; Venom Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases; Hypersensitivity, Immediate

Study Officials

• Adriana Le, MBBS FRACP

  Royal Hobart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

National Allergy Centre of Excellence

CONTACT

61 3 99366752; nace@mcri.edu.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 20, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 31, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, 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.

Locations

AU (3)