PVX-108 for Peanut Allergy

Recruiting at 14 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Aravax Pty Ltd

Disqualifiers: Severe asthma, Skin disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 45 weeks

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have severe or unstable asthma, or are on certain asthma treatments, you may not be eligible to participate.

What safety data exists for PVX-108 or similar treatments for peanut allergy?

The research does not provide specific safety data for PVX-108, but a similar treatment, TNX-901, was well tolerated in a study with patients who have peanut allergies. ^{1 2 3 4 5}

What is the purpose of this trial?

The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with peanut allergy.

Research Team

Brian Vickery, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for children and adolescents with a doctor-confirmed peanut allergy, demonstrated by specific blood tests and skin prick tests. They must have had a reaction to a small amount of peanut protein in a controlled test. Kids with moderate or severe asthma are excluded, as well as those who've tried desensitizing treatments before.

Inclusion Criteria

Peanut specific serum IgE measured by ImmunoCAP® ≥ 0.7 kilounit allergy specific antibody per litre (kUA/L) at screening

Positive skin prick test to peanut with mean wheal diameter ≥5 mm greater than negative control at screening

Physician-diagnosed immunoglobulin E (IgE) mediated peanut allergy

Exclusion Criteria

Severe or life-threatening reaction during the screening food challenge, at investigator discretion

My asthma is severe or not well-controlled according to GINA standards.

History of or current clinically significant medical conditions or laboratory abnormalities which in the opinion of the investigator would jeopardise the safety of the participant or the validity of the study results

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive twelve 4-weekly intradermal doses of PVX108 or placebo

45 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Treatment Details

Interventions

• PVX-108

Trial Overview The study is testing PVX108 immunotherapy against a placebo to see if it's safe and can reduce allergic reactions to peanuts. Participants will be randomly assigned to receive either the real treatment or the placebo.

Participant Groups

Group I: PVX108 50 nmol in children Experimental Treatment 1 Intervention

Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2)

Group II: PVX108 50 nmol in adolescents Experimental Treatment 1 Intervention

Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1)

Group III: PVX108 5 nmol in children Experimental Treatment 1 Intervention

Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2)

Group IV: Placebo in adolescents Placebo Group 1 Intervention

Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1)

Group V: Placebo in children Placebo Group 1 Intervention

Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2)

Who Is Running the Clinical Trial?

Aravax Pty Ltd

Lead Sponsor

Trials

1

Recruited

90+

Findings from Research

ASP0892, a peanut DNA vaccine, was found to be well tolerated in both adults and adolescents with peanut allergy, with the most common side effect being mild injection site itching, and no serious adverse events reported.

While ASP0892 did lead to modest increases in specific immune responses (IgG and IgG4), it did not result in significant clinical improvements in peanut allergy symptoms during food challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunopharmacology of ASP0892 in adults or adolescents with peanut allergy: two randomized trials. Ferslew, BC., Smulders, R., Zhu, T., et al.[2023]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Safety and immunopharmacology of ASP0892 in adults or adolescents with peanut allergy: two randomized trials. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Peanut (Arachis hypogaea) allergen powder-dnfp for the mitigation of allergic reactions to peanuts in children and adolescents. [2023]

3. England pubmed.ncbi.nlm.nih.gov

New approaches for the treatment of anaphylaxis. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Gender, prick test size and rAra h 2 sIgE level may predict the eliciting dose in patients with peanut allergy: Evidence from the Mirabel survey. [2020]