Long-term effects of jack jumper ant venom immunotherapy

Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation

This trial will test whether people who completed 3–6 years of jack jumper ant venom immunotherapy still have protection when given a supervised sting challenge after being off treatment for 18 months to 5 years.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Murdoch Childrens Research Institute (other)
• Drugs / interventions: immunotherapy
• Locations: 3 sites (Adelaide, South Australia and 2 other locations)
• Trial ID: NCT06935890 on ClinicalTrials.gov

What this trial studies

This prospective, multicentre phase 4 trial will recruit adults who completed a continuous 3 to <6 year JJA venom immunotherapy program at one of three Australian tertiary hospitals and stopped treatment 18 months to <5 years ago. Enrolled participants will attend an in-hospital supervised jack jumper ant sting challenge with a blood sample collected immediately beforehand; the clinical response to the sting is the primary outcome. Quality of life, anxiety and depression scores, field sting history and attitudes toward adrenaline autoinjector use will be collected at enrolment, at the challenge, one month later, and annually for three years, and retrospective treatment data will be accessed from hospital records. Optional consent will be sought for an extra serum tube to be biobanked for future analyses.

Who should consider this trial

Good fit: Adults (≥18 years) who completed a continuous 3 to <6 year jack jumper ant venom immunotherapy program at Royal Hobart, Royal Adelaide, or Monash Medical Centre and have been off treatment for ≥18 months but <5 years.

Not a fit: People who did not complete the required VIT duration, stopped treatment outside the 18-month to 5-year window, are under 18, or have medical conditions that make a sting challenge unsafe are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the trial could clarify how long protection from JJA venom immunotherapy lasts and help guide decisions about stopping or restarting treatment.

How similar studies have performed: Venom immunotherapy is established to prevent severe sting reactions and has been used for jack jumper ant allergy, but evidence about long-term protection after stopping JJA VIT is limited.

Eligibility criteria

Eligibility criteria

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

Inclusion Criteria:

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.

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.

Where this trial is running

Adelaide, South Australia and 2 other locations

• Royal Adelaide Hospital — Adelaide, South Australia, Australia (RECRUITING)
• Royal Hobart Hospital — Hobart, Tasmania, Australia (RECRUITING)
• Monash Medical Centre — Clayton, Victoria, Australia (RECRUITING)

Study contacts

• Principal investigator: Adriana Le, MBBS FRACP — Royal Hobart Hospital
• Study coordinator: National Allergy Centre of Excellence

Conditions: Allergy, Immunotherapy, Venom Allergy, Jack Jumper Ant, Venom Immunotherapy, Sting challenge, VIT