Allergy and Immunology Research Unit (AIRU)

Does your child have a peanut allergy and between 4 and 11 years of age (not yet turned 12 years)? Then this study may be beneficial to your child.

Peanut allergy is common and currently the only recommended treatment is peanut avoidance. This trial involves giving part of the peanut protein (called a peptide) to your child to investigate whether this can improve tolerance or achieve remission of your child’s peanut allergy. The product is given by injection into the top layers of the skin (intradermal) injection. The treatment period is monthly injections for 12 months. Clinically observed food challenges will be conducted in hospital to assess if peanut can be tolerated before and after the intervention.

• Study Name: ARAVAX (AVX-201)
• Sponsor: Aravax Pty Ltd
• HREC number: HREC/86862/RCHM-2022
• Age Group: 12 to 17 years (Cohort 1); 4 to 11 years (Cohort 2)
• Duration of study: 18 months – ongoing
• Study Phase: Currently recruiting children 4 years to 11 years (not yet turned 12 years)

Does your child have a peanut allergy and between 4 and 8 years of age (not yet turned 9 years)?

Peanut allergy is common and currently the only recommended treatment is peanut avoidance. This trial involves applying a patch (containing a very low dose of peanut) to the skin of your child to investigate if this can improve tolerance or achieve remission of your child’s peanut allergy. The intervention involves daily patches (worn all day) for 12 months. Clinically observed food challenges will be conducted in hospital to assess if peanut can be tolerated before and after the intervention.

• Study Name: VITESSE
• Sponsor: DBV Pty Ltd
• HREC number: HREC 93018 RCHM 2023
• Age Group: 4 to 7 years of age
• Duration of study: 18 months – ongoing
• Study Phase: Currently recruiting children 4 years to 7 years (not yet turned 8 years)

There is little evidence on rash and hypersensitivity reactions following immunisation and management of these reactions. This means that there can be a wide variation between how adverse events following immunisation may be managed. We hope that by performing this study, we will be able to establish better classification procedures of rash following immunisation, identify risk factors for these reactions and the best management for a reaction.

• Study Name: Rash and Hypersensitivity reactions following immunisation
  
• HREC number: HREC/19/WCHN/71
• Sponsor: Not sponsored
• Age Group: Children attending the Specialist Immunisation Service who have experienced rash or with suspected hypersensitivity following a vaccine.
• Study Phase: Recruiting

This trial involves investigating the safety and tolerability of an oral product with the potential to prevent the development of allergic disorders in high risk babies. The product is a mix of a live biological product that is added to breast milk or infant formula. The trial will hopefully help us improve the health outcomes for those at highest risk of developing allergic disease.

• Study Name: Adored Study (STMC-103H)
• HREC number: 2021/ETH00838
• Sponsor: Siolta Therapeutics
• Age Group: Neonates less than 7 days of age
• Duration of study: 2 years / ongoing
• Study Phase: Not recruiting

The aim of this study is to describe the experiences of children who have had chest symptoms (chest pain, chest tightness, and/or shortness of breath) without a diagnosis of myocarditis/pericarditis (inflammation of the heart) after their COVID-19 vaccine, to see how they are 3-6 months and 12-18 months later and how it’s impacted their life. Information from this project will help doctors decide how to safely vaccinate other children.

• Study Name: Chest symptoms post COVID-19 vaccine
  
• HREC number: 2022/HRE00101
• Sponsor: N/A
• Age Group: Children and adolescents vaccinated with the COVID-19 vaccine
• Study Phase: Not recruiting

The prevalence of food allergy has increased, particularly in westernised countries. The need for a curative treatment is greatest for peanut allergy because this is usually life-long and the most common cause of anaphylaxis-related fatality. Oral immunotherapy (OIT) has been explored as a strategy to induce tolerance to food allergens.

• Study Name: PPOIT-003 Follow-On
• HREC number: HREC/50943/RCHM-2019
• Age Group: 1 – 10 years
• Duration of study: 5 years / ongoing
• Study Phase: Not recruiting

Are you pregnant and do two family members (you, partner, other child) have an allergic disorder (asthma, eczema, hayfever, food allergy)?

By one year of age, approximately 10% of babies may have developed an egg allergy. This research trial is testing whether the amount of eggs and peanuts a mother eats during pregnancy and whilst breastfeeding has an influence on developing food allergy in the baby. This trial is investigating if maternal high or low dose exposure to egg and peanut during pregnancy and whilst breast feeding has any relationship with the development of food allergies.

• Study Name: PREGGNUTS
• Sponsor: NHMRC ID: 1147576
• HREC number: HREC/18/WCHN/42
• Age Group: Pregnant mothers. The father and/or mother must have one or more allergic diseases
• Duration of study: 12 months– ongoing
• Study Phase: No longer recruiting

EPITOPE is a global, Phase 3 clinical trial assessing the safety and efficacy of Viaskin Peanut (patch) for the treatment of peanut-allergic patients one to three years of age.

• Study Name: EPITOPE
• HREC number: HREC/18/SCHN/69
• Sponsor: DBV Technologies S. A.
• Age Group: 1 – 3 years
• Study Phase: Not recruiting

Continuation study from Epitope where all participants will continue onto the active patch for 12 months post passing Epitope. These kids will be subjected to an in hospital observed food challenge to help assess the efficacy of these patches.

• Study Name: EPOPEX
• HREC number: 2019/ETH13387
• Sponsor: DBV Technologies S. A.
• Age Group: All eligible subjects who completed the EPITOPE study will be offered enrolment into the EPOPEX study.
• Study Phase: Not recruiting

Peanut allergy is common and currently the only recommended treatment is peanut avoidance. This trial will involve the ability of an injected antibody (an anti-IgE monocolonal antibody) to block any food allergic reactions. This trial will help assess if your child will be able to tolerate a greater dose of peanut without a reaction when they are accidentally exposed. This trial also tests the safety and efficacy of this medication and a step closer to hoping to prevent adverse outcomes in allergic kids when exposed to peanut.

• Study Name: NOVARTIS CQGE031G12301
• HREC number: HREC/75866/RCHM-2021-268247
• Sponsor: Novartis
• Age Group: 12 – 17 years (Cohort 1); 4 – 11 years (Cohort 2)
• Duration of study: 18 months – ongoing
• Study Phase: Not recruiting

The prevalence of food allergy has increased, particularly in westernised countries. The need for a curative treatment is greatest for peanut allergy because this is usually life-long and the most common cause of anaphylaxis-related fatality. Oral immunotherapy (OIT) has been explored as a strategy to induce tolerance to food allergens.

The PPOIT (probiotic and peanut oral immunotherapy) trials are a series of studies investigating the use of the probiotic Lactobacillus rhamnosus and peanut OIT to induce sustained unresponsiveness to peanut, in other words, a possible effective treatment for peanut allergy.

• Study Name: PPOIT
• HREC number HREC/15/RCHM/128
• Sponsor NHMRC
• Age Group: 1 – 10 years
• Study Phase: Not recruiting