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UNC Food Allergy Initiative E-Newsletter

April 2021

Update on UNC Allergy Clinics and Research

Despite early concerns over COVID-19 and its implications on our ability to conduct visits with our research participants, we have implemented several safety checks and measures to ensure we can continue to keep our participants on track and maintain the safety of our families and staff.

3 Things People with Allergies Need to Know About the COVID-19 Vaccines

If you have allergies, don’t assume you can’t get the shot.

1. Allergic reactions to the vaccines are very rare, but if you’ve had one in the past, talk to your doctor before getting vaccinated.
2. All patients are monitored after receiving the vaccines.
3. The vaccines are our best hope of things returning to normal one day.

To read the full article, click here

Current Studies with the Food Allergy Initiative

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH)

  • Study Overview: The primary objective of this study is to determine if a study medication called omalizumab (Xoliar) alone or combined with oral immunotherapy may help people with multiple food allergies. Participants must have a peanut allergy and at least two other food allergies to milk, egg, wheat, cashew, hazelnut, or walnut.
  • Contact Information: Lauren Herlihy (919) 962-4406 or email

Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON) 

  • Study Overview: To determine the efficacy and safety of AR101 in a characterized oral desensitization immunotherapy (CODIT™) regimen compared with placebo in peanut-allergic children aged 1 to < 4 years.
  • Contact Information: Holly Barber (919) 962-4579

Long-term Follow-Up of Food Allergy Study Participants

With Palforzia now available, a lot of questions have come up about life after OIT. We are revamping our questionnaire for study participants to see how folks are doing on dietary peanut to create best practices and be able to provide guidance for folks in the future.

Lab Update

Figure: body temperature vs time in mice when given peanut Figure: Total Fecal IgA

A couple of years ago, our lab identified a strain of mice (CC027 mice) that can be made allergic to peanuts by simply feeding them peanut proteins once weekly for four weeks.  In January 2021, we published a paper demonstrating some important differences between the CC027 mice and another strain of mice that is resistant to developing allergy to peanuts.  The CC027 mice sensitized with peanut have a severe reaction as demonstrated by drop in body temperature, while the resistant strain (C3H) do not react.  In this paper, we reported our findings on the gut microbiome, which is the collection of all the bacteria present in the gut.  The most interesting finding was a reduced amount of Akkermansia in the CC027 mice compared with the allergy-resistant strain after peanut feeding.  This bacteria is known to influence the gut barrier and may prevent allergy by blocking the amount of peanut taken up into the blood stream after feeding.  Additionally, we found greatly reduced IgA in the gut of CC027 mice which may explain further how peanut allergens pass from the intestines into the blood stream in these mice.  Future work will focus on attempting to “normalize” the amount of Akkermansia in the gut of CC027 mice to determine whether that can prevent allergy from developing or block allergic reactions in mice that are already sensitized.  Ultimately, we aim to determine the role of Akkermansia in peanut allergic children.  Authors on this paper from the UNC FAI include: Johanna Smeekens, Andrew Hinton, Janelle Kesselring, Erin Steinbach, Kelly Orgel, Wesley Burks, and Mike Kulis.

If you would like to read more, click here.

Irradiated Tree Nut Flours for Use in Oral Immunotherapy

Anusha Penumarti | JACI: In Practice | Jan 2021

Background: Tree nut allergies affect an estimated 1% of the US population and is lifelong in 90% of allergic individuals. Oral immunotherapy (OIT) for food allergies is an effective method to induce desensitization in a majority of participants in trials of peanut, egg, and milk OIT. Limited trials using tree nut OIT have been reported, possibly due to the lack of standardized drug products.

Objective: Food products used in OIT are considered drugs by the Food and Drug Administration (FDA) because they are intended to modulate the individuals’ immune responses to the food allergens. As such, OIT drug products must meet FDA standards for acceptable levels of microbes and undergo testing for allergenic proteins. We aimed to determine the suitability of walnut, cashew, hazelnut, and almond flours for use in OIT trials.

Methods: We employed gamma irradiation on commercially available walnut, cashew, hazelnut, and almond flours and tested their levels of microbial contamination, total protein, and allergen content, along with stability of these parameters over time.

Results: Our results demonstrate that irradiation of tree nut flours greatly diminishes the levels of total aerobic bacteria, mold, yeast, Escherichia coli, and Salmonella, whereas there are no substantial changes in total protein or allergen content. Importantly, the microbial levels, protein, and allergen content remained stable over a 24-month period.

Conclusion: Irradiation of tree nut flours is a safe and effective method of processing to allow tree nut products to meet the FDA standards for OIT drug products.

Anusha Penumarti, Nicole Szczepanski, Janelle Kesselring, Elizabeth Gabel, Rohini Sheth, Jelena Berglund, Edwin H Kim, A. Wesley Burks, Michael D. Kulis (2020). Irradiated Tree Nut Flours for Use in Oral Immunotherapy. J Allergy Clin Immunol Pract. 2021 Jan;9(1):321-327. doi: 10.1016/j.jaip.2020.11.008. Epub 2020 Nov 18. PMID: 33217614

Highlights from the annual American Academy of Allergy Asthma & Immunology (AAAAI) Conference

February 29-March 1

  • Michael Kulis, PhD | Peanut Protein-Loaded Microneedle Patches are Immunogenic and Distinct from Subcutaneous Delivery
    • Stainless steel microneedles are a relatively painless way to deliver drug products into the dermal layer of the skin.
    • Peanut proteins were coated onto stainless steel microneedles and applied to mice for three minutes once per week for three weeks, leading to production of peanut-specific antibodies.
    • Importantly, peanut proteins delivered by microneedles were not detectable in blood, indicating a low risk for severe allergic reactions.
    • Additional studies are underway to determine whether this approach can treat mice with established peanut allergy.
  • Erin Steinbach, MD, PhD | Intestinal Barrier Dysfunction Accompanies Peanut Allergy in CC027/GeniUnc Mice
    • A mouse model of peanut allergy from the Collaborative Cross (CC027 mouse strain) develops increased intestinal permeability during an allergic reaction to peanut.
    • To explore intestinal epithelial cell dysfunction during peanut allergy, I performed RNA sequencing (RNA-seq) on jejunal epithelial cells before and after peanut allergy.
    • We identified 16 interesting gene products that were differentially expressed in jejunal epithelial cells during peanut allergy.
    • Further research will uncover critical functions of intestinal epithelial cells in peanut allergy pathogenesis.
  • Olivia Francis, MD | Effect on Age on Clinical and Immunologic Efficacy of Peanut Sublingual Immunotherapy
    • In the post-hoc analysis of participants ages 1-11 who underwent peanut sublingual immunotherapy, age was not significantly correlated any of the following:
      • the amount of peanut protein successfully consumed during DBPCFC at study end
      • peanut specific IgE and IgG4 at study end

Alpha-gal Research Highlights

Alpha gal figure

•    Recent experiments show an enzyme of bacterial origin present in some lone star ticks might be the source of alpha-gal in tick saliva. Next step: working with collaborators to make microbiome-free ticks
•    The FDA has approved gene edited pigs that do not have alpha-gal and should be a safe source of pork meat and porcine-derived medical products for patients with AGS. Next step: food challenges with “alpha-gal safe” pork
•    Recent publication in collaboration with the CDC and Viracor-Eurofins (allergy testing lab) documents more than 34,000 alpha-gal IgE positive individuals in the US between 2010-18



UNCFAI in the News

Baby being fed food

Peanut Sublingual Immunotherapy Feasible and Effective in Toddlers

Fran Lowery | Medscape | February 28, 2021

Sublingual immunotherapy for the treatment of peanut allergy is safe and effective, even in children as young as age 1 year.
In a double-blind, placebo-controlled, food challenge (DBPCFC) of some 36 peanut-allergic children (mean age 2.2 years, range 1 to 4 years), those who were randomly assigned to receive peanut sublingual immunotherapy (PNSLIT) showed significant desensitization compared with those who received placebo.
In addition, there was a “strong potential” for sustained unresponsiveness at 3 months for the toddlers who received the active treatment.
“A year ago, the US Food and Drug Administration approved the oral agent Palforzia (Peanut Allergen Powder) for the treatment of peanut allergy in children 4 and older, and it is a great option, but I think what we have learned over time is that this approach is not for everybody,” said Edwin H. Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina School of Medicine, Chapel Hill, in an interview with Medscape Medical News.
Palforzia is a powder that is mixed in food like yogurt or pudding which the child then eats daily, according to a rigorous schedule. But Palforzia treatment presents some difficulties.
“Palforzia requires getting the powder dose, mixing it with food, like pudding or apple sauce, then eating it, which can take up to 30 minutes depending on age and kids’ cooperation. It tastes and smells like peanut which can cause aversion. Kids have to refrain from exercise or strenuous activity for at least 30 minutes before and after dosing and have to be observed for up to 2 hours postdose for symptoms,” Kim said.
“It’s a great drug, but the treatment could be overly difficult for certain families to be able to do, and in some cases the side effects may be more than certain patients are able or willing to handle, so there is a real urgent need for alternative approaches,” Kim said. “SLIT is several drops under the tongue, held for 2 minutes, swallowed and done.”
To read the full article, click here.