VLP Peanut for Peanut Allergy

(PROTECT Trial)

Recruiting at 10 trial locations

Overseen By Pieter-Jan De Kam, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Allergy Therapeutics

Disqualifiers: Pregnancy, Severe asthma, Anaphylaxis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 14-18 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VLP Peanut, a vaccine candidate designed to help people with peanut allergies and assess its safety. It focuses on the body's reaction to the treatment, monitoring side effects and evaluating its ability to reduce allergic reactions. The trial includes different groups: healthy individuals and those with a peanut allergy. It targets adults who either have a known peanut allergy or have no history of food allergies and can consume peanuts safely. Participants with peanut allergies must follow a strict peanut-free diet and know how to use an epinephrine auto-injector. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have participated in another clinical trial with investigational drugs within 3 months before screening.

Is there any evidence suggesting that VLP Peanut is likely to be safe for humans?

Research has shown that the VLP Peanut treatment, designed to address peanut allergies, has promising safety results. In one study, even with a significant dosage increase, healthy volunteers experienced no major safety issues. Another report confirmed the treatment's safety and tolerability in trials, with no serious safety concerns in any trial group. These findings suggest that VLP Peanut has a positive safety profile. Although still in early testing, the treatment could be a safe option for people with peanut allergies. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for peanut allergy?

Unlike the standard treatments for peanut allergies, which typically involve strict avoidance and the use of epinephrine for emergency reactions, VLP Peanut introduces a novel approach. It uses virus-like particles (VLPs) to present peanut proteins to the immune system, potentially retraining the body to tolerate peanuts over time. This innovative method could reduce the severity of allergic reactions or potentially eliminate them altogether. Researchers are excited about VLP Peanut because it offers a proactive way to manage peanut allergies, rather than just reacting to them.

What evidence suggests that VLP Peanut might be an effective treatment for peanut allergy?

Research has shown that VLP Peanut, which participants in this trial may receive, may help treat peanut allergies. Studies have found that this treatment can lessen allergic reactions, as seen in skin tests. It builds a strong immune response against a peanut protein called Ara h 2, which often causes allergic reactions. In lab tests, VLP Peanut stopped this protein from attaching to cells, potentially reducing the chance of allergic reactions. Additionally, research in mice showed that VLP Peanut triggered protective immune responses without harmful side effects. These early findings suggest that VLP Peanut could be a promising option for managing peanut allergies. ^{4 5 6 7 8}

Who Is on the Research Team?

Pieter-Jan De Kam, PhD

Principal Investigator

Allergy Therapeutics

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with peanut allergy, aged 18-50, who can consent to participate. Women must not be pregnant or breastfeeding and should follow birth control guidelines if of childbearing potential. Excluded are those with severe anaphylaxis history to other allergens, certain skin conditions, inability to receive epinephrine, recent participation in another trial or substance abuse.

Inclusion Criteria

I am able to understand and sign the consent form.

Good general health, as determined by the Investigator

A positive SPT to histamine

Exclusion Criteria

Participation in a clinical research trial with any investigational drug/placebo within 3 months of screening (Visit 1) or concomitantly with this clinical trial

Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the clinical trial site, Sponsor, Sponsor's representative, or another individual who has access to the clinical trial protocol

History of severe or life-threatening anaphylactic reactions to peanut resulting in neurological compromise or requiring mechanical ventilation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 ascending subcutaneous administrations of VLP Peanut

14-18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• VLP Peanut

Trial Overview The study tests VLP Peanut's safety and how well it's tolerated in both healthy people and those allergic to peanuts. It also examines the immune response it triggers. Participants will either receive the VLP Peanut or a placebo without active ingredients.

How Is the Trial Designed?

Group I: Part B - Cohorts 1-4 Experimental Treatment 2 Interventions

4 parallel cohorts (1-4) of peanut allergic subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.

Group II: Part A - Group A2 Experimental Treatment 1 Intervention

Adult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.

Group III: Part A - Group A1 Experimental Treatment 1 Intervention

4 parallel cohorts (1-4) of adult healthy subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.

VLP Peanut is already approved in United States for the following indications:

Approved in United States as VLP Peanut for:

• Peanut Allergy

Who Is Running the Clinical Trial?

Allergy Therapeutics

Lead Sponsor

Trials

26

Recruited

4,900+

Published Research Related to This Trial

In a real-world study involving 270 preschool children undergoing peanut oral immunotherapy (P-OIT), 90% successfully reached the maintenance dose, indicating high treatment adherence and efficacy.

The majority of reactions during treatment were mild, with only 4.1% of patients requiring epinephrine, suggesting that P-OIT is generally safe, although there is a small risk of severe reactions in some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Real-World Safety Analysis of Preschool Peanut Oral Immunotherapy. Soller, L., Abrams, EM., Carr, S., et al.[2020]

Virus-like particles (VLPs) derived from Turnip mosaic virus (TuMV) can be genetically engineered to carry allergens like Pru p 3, showing promise as a safe and effective treatment for food allergies, as demonstrated in a mouse model.

The VLP-Complex formulation was able to reduce allergic response markers without causing toxicity, indicating its potential as a non-hazardous immunomodulatory therapy for immune-based conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suitability of potyviral recombinant virus-like particles bearing a complete food allergen for immunotherapy vaccines. Pazos-Castro, D., Margain, C., Gonzalez-Klein, Z., et al.[2023]

In a phase 1 trial involving 15 participants (5 healthy adults and 10 peanut-allergic adults), the rectal administration of the modified peanut protein vaccine EMP-123 showed no significant adverse effects in healthy volunteers, but 50% of peanut-allergic subjects experienced adverse reactions, including severe allergic reactions in 20%.

Despite the adverse reactions, the treatment led to significant reductions in peanut skin test responses and basophil activation, indicating some immunologic effects, although no significant changes were observed in total IgE or peanut-specific IgE levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 study of heat/phenol-killed, E. coli-encapsulated, recombinant modified peanut proteins Ara h 1, Ara h 2, and Ara h 3 (EMP-123) for the treatment of peanut allergy. Wood, RA., Sicherer, SH., Burks, AW., et al.[2021]

Patients with peanut allergy (PA) exhibited a unique population of peanut-responsive CD4+ T cells that showed a heterogeneous pattern of TH2 differentiation, which was not present in healthy controls or high-threshold subjects.

The study found that these TH2 cells in PA patients produced multiple cytokines associated with allergic responses, indicating a complex immune response beyond just IgE production, and highlighted a significant role of regulatory T cells in modulating this response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-cell profiling of peanut-responsive T cells in patients with peanut allergy reveals heterogeneous effector TH2 subsets. Chiang, D., Chen, X., Jones, SM., et al.[2020]

The VLP Peanut vaccine, which combines virus-like particles with peanut allergen Ara h 2, shows that the presence of prokaryotic RNA is crucial for generating strong immune responses, specifically through TLR 7 signaling, which enhances the production of high-avidity IgG antibodies.

A strong correlation was found between the density of Ara h 2 antigens on the VLP Peanut particles and the vaccine's effectiveness, indicating that both RNA content and antigen density are critical factors for the vaccine's immunogenicity and protective capacity against peanut allergy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of antigen density and TLR ligands on preclinical efficacy of a VLP-based vaccine against peanut allergy. Krenger, PS., Josi, R., Sobczak, J., et al.[2023]

The novel vaccine candidate VLP Peanut, which combines virus-like particles with peanut allergen components, has shown to induce a strong immune response in both naïve and peanut-sensitized mice without causing allergic reactions.

VLP Peanut not only provides protection against peanut allergens but also alleviates allergic symptoms upon exposure, demonstrating its potential as a preventive immunotherapy for peanut allergy, and it has progressed to clinical development in the study PROTECT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The next generation virus-like particle platform for the treatment of peanut allergy. Sobczak, JM., Krenger, PS., Storni, F., et al.[2023]

Ara h 1-reactive CD4(+) T cells were found in all tested subjects with peanut allergy, indicating a consistent immune response to the peanut allergen.

These T cells predominantly expressed CCR4 and produced various cytokines, including IL-4, suggesting their role in the allergic response, and the use of class II tetramers allows for effective tracking of these cells during immunotherapy without needing to expand them in the lab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ara h 1-reactive T cells in individuals with peanut allergy. DeLong, JH., Simpson, KH., Wambre, E., et al.[2021]

After one year of peanut oral immunotherapy (P-OIT), 78.6% of preschoolers showed desensitization, successfully passing a follow-up food challenge with 4000 mg of peanut protein.

For those who did react during the follow-up, their reaction threshold increased significantly by an average of 3376 mg, indicating that P-OIT effectively enhances tolerance and may protect against accidental peanut exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Real-World Effectiveness Analysis of Preschool Peanut Oral Immunotherapy. Soller, L., Abrams, EM., Carr, S., et al.[2021]

Citations

1. firstwordpharma.com firstwordpharma.com/story/6322542

Allergy Therapeutics announces further positive progress ... A protective dose-dependent inhibition of Ara h2 IgE binding to B cells was observed after treatment with VLP Peanut compared to placebo. This ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36883475/

The next generation virus-like particle platform for ... Immunizations with VLP Peanut in both naïve and peanut-sensitized mice resulted in a significant anti-Ara h 2 IgG response. Local and systemic protection ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0091674924008601

Ara h 2–expressing cucumber mosaic virus–like particle ... VLP Peanut showed beneficial biochemical properties, fit for use in clinical studies. VLP Peanut induced IFN-γ+ TH1 (P < .05) while having reduced capacity to ...

4. trinitydelta.org trinitydelta.org/research-notes/vlp-peanut-heading-towards-us-phase-i-studies/

VLP Peanut heading towards US Phase I studies Allergy Therapeutics' VLP Peanut vaccine ex-vivo study has successfully met all primary and secondary endpoints. These confirm the safety is as hoped, with ...

5. proactiveinvestors.com proactiveinvestors.com/companies/news/1080467/allergy-therapeutics-advances-peanut-allergy-vaccine-with-promising-early-trial-data-1080467.html

Allergy Therapeutics advances peanut allergy vaccine with ... Earlier results showed a reduction in allergic responses in treated patients, measured by skin prick tests using whole peanut extract. The ...

6. jacionline.org jacionline.org/article/S0091-6749(24)02314-5/fulltext

First-in-human VLP Peanut Vaccine Candidate: Safety and ... PROTECT is currently still ongoing, but safety data observed following a 400-fold and 50-fold increase from the first subcutaneous dose, for healthy volunteers ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37815010/

Influence of antigen density and TLR ligands on preclinical ... Immunogenicity and peanut allergen challenge studies were conducted with VLP Peanut low RNA, as well as with VLP Peanut in WT and TLR 7 KO mice.

8. healio.com healio.com/news/allergy-asthma/20250325/peanut-allergy-vaccine-deemed-safe-tolerable-in-phase-1-study

Peanut allergy vaccine deemed safe, tolerable in phase 1 ... A hypoallergenic therapeutic vaccine candidate for peanut allergy was safe and tolerable, according to a poster presented at the 2025 American Academy of ...