About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Jack Jumper Ant Venom Immunotherapy
Other intervention
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.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Participants who have completed Jack Jumper Ant Venom Immmunotherapy treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

2

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

Secondary outcomes

1

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

2

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

3

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

4

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

Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts