Long-term effects of jack jumper ant venom immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: nace@mcri.edu.au
• Phone: 61 3 99366752

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.