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VLP Peanut for Peanut Allergy (PROTECT Trial)
PROTECT Trial Summary
This trialis testing a potential new treatment for peanut allergies. It will explore its safety, tolerability & efficacy in healthy & allergic people.
PROTECT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PROTECT Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I am able to understand and sign the consent form.My eczema affects more than 25% of my skin.I am between 18 and 50 years old.I have severe asthma that is not well controlled.I am not able to have children or agree to follow the study's birth control rules.I am either male or female.
- Group 1: Part A - Group A1
- Group 2: Part A - Group A2
- Group 3: Part B - Cohorts 1-4
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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)."
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."
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