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Virus Therapy

VLP Peanut for Peanut Allergy (PROTECT Trial)

Phase 1
Recruiting
Research Sponsored by Allergy Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up group a1: 18 weeks; group a2: 2-5 days; part b: 16 weeks
Awards & highlights

PROTECT Trial Summary

This trialis testing a potential new treatment for peanut allergies. It will explore its safety, tolerability & efficacy in healthy & allergic people.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, general allergic responses due to immunotoxicity assessment (like hives or swelling), but specific side effects will be closely monitored given this is a phase I trial assessing safety.

PROTECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~group a1: 18 weeks; group a2: 2-5 days; part b: 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and group a1: 18 weeks; group a2: 2-5 days; part b: 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and severity of Adverse Events (AEs) (including local and systemic AEs).
Therapeutic procedure
Secondary outcome measures
Alterations in Red Blood Cells (RBC) levels
Alterations in Serum Chemistry (Alanine aminotransferase)
C-reactive protein
+50 more

PROTECT Trial Design

3Treatment groups
Experimental Treatment
Group I: Part B - Cohorts 1-4Experimental Treatment2 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 A2Experimental Treatment1 Intervention
Adult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.
Group III: Part A - Group A1Experimental Treatment1 Intervention
4 parallel cohorts (1-4) of adult healthy subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Allergy TherapeuticsLead Sponsor
25 Previous Clinical Trials
4,808 Total Patients Enrolled
Pieter-Jan De Kam, PhDStudy DirectorAllergy Therapeutics

Media Library

VLP Peanut (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05476497 — Phase 1
Peanut Allergy Research Study Groups: Part A - Group A1, Part A - Group A2, Part B - Cohorts 1-4
Peanut Allergy Clinical Trial 2023: VLP Peanut Highlights & Side Effects. Trial Name: NCT05476497 — Phase 1
VLP Peanut (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05476497 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of participants are ideal for this experiment?

"This clinical trial is recruiting 58 volunteers aged 18-50 years to participate, of whom must be in good physical health and have a confirmed peanut allergy. Participants need to provide informed consent and also meet the following requirements: no history of allergies or intolerance towards peanuts; non-atopic with no clinically significant co-morbidity such as asthma or rhinitis; female subjects who are not of childbearing potential (or females of childbearing potential who comply with contraceptive protocols); lack of sensitivity to peanut allergen verified via SPT using whole peanut extract."

Answered by AI

What is the upper limit on participants in this clinical trial?

"Affirmative. According to the details featured on clinicaltrials.gov, this medical trial is actively recruiting participants with a post date of October 1st 2022 and an edit date of October 6th 2022. 58 volunteers will be recruited from 2 sites for inclusion in the study."

Answered by AI

What safety measures have been taken to guarantee the wellbeing of those in Part A - Group A1?

"Our team at Power assigned Part A - Group A1 a score of 1 on our safety scale due to the preliminary nature of this Phase 1 trial, which has demonstrated limited efficacy and data regarding its protection against harm."

Answered by AI

Is the upper age limit for this clinical trial restricted to 35 years or older?

"This clinical trial is open to individuals 18 through 50 years of age. However, there are other studies that focus on those younger and older than the eligibility limits stated here--85 trials for minors and 156 for seniors."

Answered by AI

What objectives is this research project attempting to fulfill?

"The primary objectives of this clinical trial monitored across 11 and 15 weeks respectively are to assess the occurrence and severity of Adverse Events (AEs) both locally and systemically. Secondary goals include measuring levels of fatigue, fever symptoms, as well as alterations in serum chemistry such as Alanine aminotransferase (ALT)."

Answered by AI

Are there any vacant participant slots in this trial?

"Affirmative. According to clinicaltrials.gov, the study is actively enrolling participants and has recorded two updates since its initial posting on October 1st 2022. A total of 58 patients need to be recruited from 2 different medical facilities."

Answered by AI
~22 spots leftby Oct 2025