First-in-human trial tests microneedle stamp approach for peanut allergy

Peanut allergy affects more than 1.2 million children in the United States and carries the risk of potentially serious reactions following accidental exposure. Although treatment options for food allergy have expanded in recent years, researchers continue to investigate approaches that could make allergen immunotherapy more convenient and accessible for children and families.

A first-in-human phase 1 clinical trial led by Children’s Healthcare of Atlanta and Emory University School of Medicine is evaluating a new approach: a microneedle stamp designed to deliver small, controlled doses of peanut protein into the skin. Developed by Moonlight Therapeutics, Inc., the nickel-sized stainless steel device is applied to the forearm for approximately 3 minutes. Unlike therapies in which an allergen remains on the surface of the skin, the microneedles are designed to penetrate slightly into the skin and deliver peanut protein directly. The current trial is focused on safety and tolerability, as well as identifying a dose that could be evaluated in subsequent studies for its ability to alter the immune response and produce clinical desensitization.

Brian Vickery, MD, chief of Allergy and Immunology at Children’s Healthcare of Atlanta, vice chair of Clinical Research in the Department of Pediatrics at Emory University School of Medicine, and principal investigator of the multisite trial, spoke with Contemporary Pediatrics about how the technology works, what investigators hope to learn from the phase 1 study, and where a microneedle-based approach could eventually fit into the evolving peanut allergy treatment landscape. Vickery also discusses the trial’s planned progression from adults to adolescents and potentially children as young as 4 years, as well as what pediatricians should understand about the promise—and current limitations—of this investigational approach.

Contemporary Pediatrics: This is the first time this microneedle stamp has been tested in humans. What makes this approach different from existing peanut allergy therapies, and why could delivering peanut protein through the skin offer advantages?

Brian Vickery, MD: Unlike epicutaneous patches worn continuously with protein sitting on the skin surface, the microneedle stamp inserts peanut protein less than 1 mm into the skin during a single 3-minute application. Since the microneedles only go slightly into the skin, the application may be less painful than an injection, and rather than the peanut proteins sitting on the outside like other skin patch therapies, we believe the stamp may be more effective at improving immune response to peanut allergy.

Contemporary Pediatrics: Although this phase 1 trial is focused on safety and tolerability, what early signals will you be looking for that could indicate the microneedle platform has the potential to induce immune tolerance in future studies?

Vickery: We will start with one microgram of peanut protein and gradually increase the dose as tolerated, to determine which dose could be tested in subsequent studies to create a change in immune response. The ascending-dose approach reflects a typical Phase 1 design, in which we hope to identify the highest dose that is well-tolerated so that we may test it in a future efficacy study.

Contemporary Pediatrics: Current FDA-approved options for peanut allergy have practical limitations for many families. If this technology ultimately proves safe and effective, how could it change the way pediatric allergists manage peanut allergy?

Vickery: Only 2 therapies have been FDA-approved for food allergies. One requires a subcutaneous injection of an antibody every 2 to 4 weeks, and the other, which was recently discontinued by the manufacturer, involves mixing powder into food daily. Home use is a goal for future development but is not part of the current protocol. We're a long way away from that. But if successful, pediatric allergists would be managing a therapy that is less painful than the current injections and possibly able to be delivered at home, instead of in the clinic. A non-oral route that could be administered in 3 minutes offers patients advantages compared to the current alternatives.

Contemporary Pediatrics: The study begins in adults before moving into adolescents and eventually children as young as 4 years. What safety considerations drive that stepwise approach, and what will need to be demonstrated before younger children can be enrolled?

Vickery: The trial will recruit adults aged 18-26 to be seen at Children’s in the initial cohort. Following a safety review, if the stamp is determined to be sufficiently safe in adults, younger teens will be enrolled into the second cohort. Children as young as 4 years of age could be enrolled in the third cohort, following an adolescent safety review. Data from each cohort will be reviewed by an independent Data Safety and Monitoring Board convened by the NIH. The study protocol contains stopping rules that specify the adverse events that would limit participation for individuals and for the entire study should events accumulate across participants. These are the typical allergic adverse events that are always prioritized in food allergy studies, such as systemic allergic reactions (anaphylaxis), discomfort at the application site, and voluntary withdrawal from the study.

Contemporary Pediatrics: Many pediatricians care for children with peanut allergy long before they're referred to an allergist. Based on where this research stands today, what should primary care pediatricians tell families who are hopeful about emerging immunotherapy options like this one?

Vickery: It’s important to note that this is a phase 1 trial. We are first exploring whether a peanut allergy microneedle stamp is effective and safe for patients. We need to complete phase 2 and 3 trials as well as obtain FDA authorization of the device before it is available. While we are hopeful this new approach will be a viable option, we are a long way from knowing that and making it available. Pediatricians should know that there are many new approaches for peanut and other food allergies that are currently being studied in clinical trials like this one, and as such, their patients may have new options for treatment available in the future.

Reference

Children’s Healthcare of Atlanta. Children’s leads first-in-human peanut allergy trial testing Atlanta-based microneedle skin stamp. Published June 25, 2026. Accessed September 29, 2026. https://www.choa.org/about-us/newsroom/childrens-leads-first-in-human-peanut-allergy-trial-testing-atlanta-based-microneedle-skin-stamp