Under the Microscope
The Sean N. Parker Center for Allergy and Asthma Research at Stanford University hosts a number of clinical trials in an effort to develop therapies for food allergies. Currently, they are conducting two peanut allergy clinical trials for adults, which is good news for people like me with a severe peanut allergy. But I have questions … several questions. In the following interview, Tina. Sindher, MD, one of the doctors involved in the clinical trial, provides some answers.
Q: What made Stanford University School of Medicine decide to research food allergies?
A: There is a great need for food allergy research at this time since the incidence of food allergy has been going up for the past several decades and we still don’t completely understand why. The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is the first center of its kind —aiming not only to find better treatments for children and adults with allergies and asthma, but to discover underlying immune mechanisms against diseases and develop a lasting cure. Researching peanut allergies, specifically, is an important piece of the puzzle.
Q: Can you please describe each phase of the peanut clinical trial?
A: Each clinical trial is designed to answer specific questions, whether it be to determine proof-of-concept, safety, efficacy or other important factors, such as ideal dosing. All clinical trials have strict eligibility requirements, with patient safety as the first and foremost consideration.
Depending on the protocol of the specific clinical trial, once a participant is screened and determined to be eligible, they may or may not be randomly placed in a placebo or an active arm of the trial. Some trials are designed to answer questions about maintenance phases — what happens after someone is treated. In this type of a trial, everyone is initially included in an active phase, and then participants may be randomly assigned to an active or placebo arm during a maintenance phase. In further variations, a participant and the study coordinator may not know that the participant is in a placebo arm. This is defined as a double-blind placebo study.
Q: How do you determine who are the best candidates (demographics, allergy testing, personality type)?
A: Individuals interested in participating in a clinical trial at our center can join our registry at is.gd/snpregistry. When we begin a new study, we look through our registry first for individuals who fit the criteria for the new study (such as age range or specific food allergy). Based on the information we have, if someone appears to meet the requirements, we reach out to them for an initial screening usually by phone.
If the participant is interested, then they come in for an office visit and we further screen them for eligibility. This visit can include some or all of the following (depending on the study): skin prick testing, oral food challenge, blood tests, spirometry, etc.
Eligibility criteria generally includes factors such as age range and measurable disease using many variables. For instance, if someone has a peanut allergy, the skin prick test must be a certain size, and blood test measuring peanut allergy needs to be a certain value. Eligibility requirements standardize clinical data and results but are strict in order to minimize risk to participants. If a potential participant has chronic conditions that may make participation dangerous for them, then we cannot include them.
We currently do have a long waitlist but, we are working hard to provide access to studies and generally begin new studies every few months.
Q: Can you break down the steps of each clinical trial and what one can expect after they are enrolled? How long does this process take?
A: Each study has a slightly different time frame. One of our current peanut studies is 60 days, while another one is just over 200 days. We presently have active studies that have been ongoing for several years.
The best way to find out about the specifics of each clinical trial is through ClinicalTrials.gov. All trials across the country are registered on that website. Our center is participating in the following two clinical trials for peanut-allergic individuals 18 and older.
- Placebo-Controlled Study to Investigate ANB020 Activity in Adult Patients With Peanut Allergy https://clinicaltrials.gov/ct2/show/NCT02920021?term=ANB020&rank=1
- A Study to Evaluate Safety, Tolerability and Immune Response in Adults Allergic to Peanut After Receiving Intradermal or Intramuscular Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccinehttps://clinicaltrials.gov/ct2/show/NCT02851277?term=ASP0892&rank=1
Q: After completion of the clinical trial, is the best-case scenario that the individual will no longer have a fatal reaction to peanuts?
A: We have had several success stories where the participant was able to eat the food(s) that they were treated for in their trial. However, no treatment so far has a 100% success rate.
To learn more about the clinical trial or to participate, feel free to reach out to firstname.lastname@example.org. Additionally, you can read about some of the clinical trial participants’ individual journeys on med.stanford.edu/allergyandasthma/clinical-trials.