PVX-108 for Peanut Allergy

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called PVX-108 to determine if it can safely reduce allergic reactions to peanuts in children and teens. Some participants will receive the treatment, while others will receive a placebo—a harmless substance resembling the treatment but with no effect—for comparison. The trial targets individuals diagnosed with a peanut allergy who have experienced allergic reactions to peanuts. Those whose peanut allergy affects daily life might find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PVX-108 is generally safe for people with peanut allergies. In earlier studies, adults with these allergies tolerated it well, with no serious side effects or allergic reactions linked to the treatment. Since PVX-108 doesn't contain whole peanut protein, it can be administered safely without the need to increase the dose over time. These findings suggest that the treatment is likely safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for peanut allergy?

Researchers are excited about PVX-108 for peanut allergy because it offers a novel approach to treatment. Unlike standard therapies that often involve oral immunotherapy, PVX-108 is administered through intradermal injections, which could potentially reduce the risk of severe allergic reactions. This treatment targets the immune system directly beneath the skin, aiming to desensitize the body to peanut allergens more safely and efficiently. By focusing on a different delivery method and mechanism of action, PVX-108 has the potential to provide a more tolerable and effective option for managing peanut allergies.

What evidence suggests that PVX-108 could be an effective treatment for peanut allergy?

Research has shown that PVX-108, which participants in this trial may receive, holds promise as a treatment for peanut allergies. Previous patients demonstrated that PVX-108 can safely reduce allergic reactions to peanuts. Specifically, one study found that PVX-108 treatment significantly reduced severe allergic reactions during peanut tests. This treatment calms certain immune cells, potentially lessening allergic responses. Overall, these findings suggest that PVX-108 could effectively manage peanut allergies, offering hope to those affected. ^{1 2 4 6 7}

Who Is on the Research Team?

Brian Vickery, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05621317

NCT05621317 | A Safety and Efficacy Study of PVX108 in ...

The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38112286/

Phase 1 trial supports safety and mechanism of ... - PubMed

Results: PVX108 induced negligible activation of peanut-sensitised basophils. PVX108 was safe and well tolerated in peanut-allergic adults.

3.

jacionline.org

jacionline.org/article/S0091-6749(18)32701-5/fulltext

PVX108 Peptide Immunotherapy Significantly Reduces ...

PVX108 treatment significantly reduced anaphylaxis following peanut challenge. Sensitized, placebo-treated mice experienced a mean maximum temperature drop of ...

4.

trials.foodallergy.org

trials.foodallergy.org/trials/NCT05621317

A Safety and Efficacy Study of PVX108 in Children and ...

Treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/all.15966

Phase 1 trial supports safety and mechanism of action of ...

PVX108 was safe and well tolerated in peanut-allergic adults. There were no treatment-related hypersensitivity events or AEs of clinical concern ...

6.

aaaai.org

aaaai.org/about/news/news/peanut-trial

New Phase One Peanut Allergy Immunotherapy Trial Results

PVX108 does not contain whole peanut protein, so can be administered safely without dose escalation. While still early, the data suggest that monthly ...

7.

jacionline.org

jacionline.org/article/S0091-6749(18)32717-9/fulltext

Safety and Tolerability of a Novel Peptide-Based ...

Basophil reactivity and phase I data demonstrate that PVX108 has a highly favourable safety profile for treatment of peanut allergic individuals, including ...