Brian Vickery, MD, chief of allergy and immunology at Children's Healthcare of Atlanta.

Brian P. Vickery, MD

affects more than 1.2 million children in the US and has only 2 

injectable antibody administered every 2 to 4 weeks

 without altering the underlying immune response to the allergen (omalizumab) and an 

oral immunotherapy powder recently discontinued by its manufacturer

 (Palforzia).¹ A first-in-human phase 1 trial testing a new option, a microneedle skin stamp, opened June 24, 2026, at Children's Healthcare of Atlanta.¹ The device, developed by Atlanta-based Moonlight Therapeutics, Inc., received FDA clearance for human testing in late 2025.¹

The stamp delivers peanut protein < 1 mm into the outer layers of skin during a 3-minute application, unlike epicutaneous patches, where protein sits on the skin surface for continuous wear.² Investigators are using an ascending-dose design, starting participants at 1 microgram of peanut protein and escalating weekly to a ceiling of 100 micrograms if tolerated.¹ The study spans 5 US sites led by Children's and Emory University, enrolling adults first before moving to adolescent and pediatric cohorts pending safety review.¹

 spoke with lead investigator Brian Vickery, MD, chief of allergy and immunology at Children's Healthcare of Atlanta and vice chair of clinical research in the department of pediatrics at Emory University School of Medicine, about this ongoing trial. In this Q&A, he discusses the mechanistic rationale behind the microneedle platform, the trial's dose-escalation design and safety monitoring, and his outlook for where this approach could fit into the food allergy treatment landscape.

Q&A: Inside the First-in-Human Peanut Allergy Microneedle Stamp Trial

How does the microneedle delivery mechanism differ mechanistically from existing epicutaneous patch therapies, and why might it improve immune response?

 With epicutaneous immunotherapy, which is also in development, the peanut proteins sit on the outside of the skin. They're attached to a disc adhered to the skin and designed to be worn continuously, 24/7. With continued use, the peanut proteins release from the patch and sit on the outside of the skin, where they may come in contact with immune cells but remain on the other side of the skin barrier.

With microneedles, the delivery system actually inserts the peanut proteins through the outer layers of skin, less than a millimeter deep. It's still very superficial, but it breaks through the top layer of skin, which may make it easier for the immune cells residing within the skin to interact with those peanut proteins, which we hope will improve its effectiveness. Importantly for patients, it also does not require them to use the system 24/7. It's applied for just a few minutes and then removed.

Can you walk through the dose-escalation design, starting at 1 microgram of peanut protein?

 Like many other phase 1 studies, participants are exposed to a range of doses starting with a tiny first dose, 1 microgram of peanut protein. For reference, a microgram is 1/1000th of a milligram, and a peanut kernel is about 300 milligrams, so we're talking about a tiny fraction of 1 peanut on the first day. Participants come into the research unit, have 1 microgram placed, and that's the only exposure for the first day. We observe them, discharge them home, and they come back a week later to try a slightly higher dose, 5 micrograms, then 10 micrograms the next week, and so on, and we cap the exposure at 100 micrograms if tolerated.

What safety signals or adverse events are you watching most closely in this first-in-human application?

 The allergic reactions we're most concerned about would be a systemic allergic reaction, where patients may experience symptoms in different parts of their body, potentially even anaphylaxis. We're on guard for that and prepared to manage it if it happens. More likely, what we'll see is localized allergic reactions around the injection site. When you expose sensitive people to the thing they're allergic to, you often get itching, redness, swelling, [and] hives.

 What did earlier immunotherapy approaches teach you about dosing precision that shaped this trial's design?

 We can establish the average dose at which people might react, but we recognize from previous studies there's quite a range of sensitivity. Some patients are exquisitely sensitive to tiny amounts, which is why this microneedle platform is so attractive: the dose can be very precisely controlled and reliably administered even at these tiny microgram quantities.

 If early safety and tolerability data are positive, what would the path toward a pivotal efficacy trial look like?

 The next study would be a phase 2 study with repeated-dose administration over a period of months, perhaps up to 52 weeks. In food allergy, efficacy studies also include oral food challenges, both at baseline and at the end of treatment, to show how well or not the immunotherapy works to change reactivity. This current phase 1 study does not include food challenges, so that will be an important component of studies moving forward.

 Is there anything else you'd like to highlight about the study and where it stands?

 It's important to know this is a phase 1 study, happening at 5 sites across the US, initially enrolling an adult cohort. Once the adult cohort closes, the data will be reviewed by a data safety and monitoring committee, and we will then ask that committee for permission to open the next cohort, which will be adolescents, and we'll repeat the process. We'll enroll 10 adolescents and then review those data with the data safety and monitoring committee, and if approved to do so, we would open a pediatric cohort down to age 4 and enroll 20 children.

Watch our video interview with Vickery here: 

Microneedle Stamp Enters Phase 1 Trial for Peanut Allergy Immunotherapy

Microneedle Peanut Allergy Trial Charts Path to Pivotal Testing

Children's Healthcare of Atlanta. Children's leads first-in-human peanut allergy trial testing Atlanta-based microneedle skin stamp. Published June 24, 2026. Accessed August 18, 2026. 

https://www.choa.org/about-us/newsroom/childrens-leads-first-in-human-peanut-allergy-trial-testing-atlanta-based-microneedle-skin-stamp

Vickery B. Microneedle Stamp Enters Phase 1 Trial for Peanut Allergy Immunotherapy. HCPLive Published August 18, 2026. Accessed August 19, 2026. 

https://www.hcplive.com/view/microneedle-stamp-trial-peanut-allergy-immunotherapy

Vickery B. Microneedle Peanut Allergy Trial Charts Path to Pivotal Testing. HCPLive. Published August 19, 2026. Accessed August 19, 2026. 

https://www.hcplive.com/view/microneedle-peanut-allergy-trial-path-pivotal-testing

Articles

Peanut allergy affects >1.2 million US children and currently has limited FDA-approved therapeutic options. A first-in-human phase 1 study is evaluating a microneedle “skin stamp” that delivers microgram quantities of peanut protein <1 mm into superficial skin layers during a brief, 3-minute application. The trial uses weekly ascending doses from 1 to 100 µg across 5 US sites, enrolling adults before adolescents and children after DSMC review. Primary concerns include systemic reactions, including anaphylaxis, and localized site reactions.

Brian Vickery, MD, discusses the mechanism, dose-escalation design, and outlook for a first-in-human microneedle immunotherapy trial for peanut allergy.

Brian Vickery, MD, principal investigator of a first-in-human phase 1 trial testing a microneedle 

 stamp at Children's Healthcare of Atlanta, has outlined a phase 2 and phase 3 development path contingent on safety data from the ongoing study.¹

Vickery, who also serves as vice chair of clinical research in the department of pediatrics at Emory University School of Medicine, has an ownership interest in Moonlight Therapeutics, Inc., the company developing the device.¹ The ascending-dose safety study is enrolling an initial adult cohort before proceeding through an age-de-escalating design toward younger participants.¹

"I think there's a real opportunity for a treatment like this to gain traction because there is still a lot of unmet need in the space," Vickery told 

. Many patients in his clinic remain ineligible for existing food allergy therapies or have tried them and experienced an adverse effect.

Path From Phase 1 Safety Data to a Pivotal Efficacy Trial

The current study is designed to test safety and tolerability, with an additional goal of identifying a dose to carry into a phase 2 trial, according to Vickery. A phase 2 study would introduce repeated dosing over a period of months, potentially up to 52 weeks, to test for the first time whether the treatment changes reactivity to peanuts.

Efficacy studies in food allergy typically include oral food challenges at baseline and at the end of treatment to measure how reactivity shifts with immunotherapy. The current phase 1 protocol does not include food challenges, leaving this as a component reserved for later-stage studies.

If a phase 2 trial shows a signal toward efficacy, Vickery said the data would support the design of a properly powered, pivotal phase 3 study. This sequence, moving from safety to a repeated-dose efficacy signal to a pivotal trial, follows a conventional path for early-phase immunotherapy development.¹

Peanut Allergy Trial Cohorts, Sites, and Age De-Escalation

The phase 1 trial is enrolling young adults and adults aged 18 to 26 years at Children's Healthcare of Atlanta and adults aged 27 to 55 years at Emory University in its initial cohort.¹ Following review by a data safety and monitoring committee, investigators plan to open a second cohort enrolling 10 adolescents, repeating the review process before any further expansion.¹ If the adolescent cohort is cleared, a third cohort would enroll 20 children as young as 4 years old, following an additional safety review by the committee.¹

A phase 2 trial, if pursued, would test repeated microneedle dosing over up to 52 weeks with oral food challenges to assess efficacy.

The phase 1 study proceeds through an age-de-escalating design, from adults to a 10-participant adolescent cohort to a 20-child pediatric cohort down to age 4.

Each cohort transition requires data safety and monitoring committee review before enrollment can proceed.

Enrollment spans 5 sites nationally: Children's and Emory University in Atlanta, the University of North Carolina at Chapel Hill, the University of Arkansas, the University of Michigan, and a clinical research organization in Nebraska.¹ Vickery said the design lets investigators characterize safety in adults before extending exposure to pediatric participants.

Looking 5 to 10 years ahead, Vickery said he would like to see many treatment options for food allergies.

“As an allergist seeing patients, I would love to have a toolkit of 4, 5, 6 options to offer patients because we recognize that one size does not fit all in this condition,” he added.

Watch part 1 of our interview with Vickery here:

Microneedle Stamp Enters Phase 1 Trial for Peanut Allergy Immunotherapy.

Reported disclosures for Vickery include Genentech USA, AQUESTIVE THERAPEUTICS, and Novartis Pharmaceuticals Corporation.

Vickery B. Microneedle Stamp Enters Phase 1 Trial for Peanut Allergy Immunotherapy. HCPLive Published August 18, 2026. Accessed August 18, 2026.

Videos

Investigators outline how phase 1 safety data could inform a phase 2 efficacy study and eventual pediatric enrollment down to age 4 years.

Children's Healthcare of Atlanta has opened a first-in-human phase 1 trial testing a microneedle skin stamp designed to deliver peanut protein immunotherapy through the outer layers of skin in 3 minutes among patients with 

Only 2 therapies currently carry US Food & Drug Administration (FDA) approval for food allergy: an injectable antibody administered every 2 to 4 weeks without altering the underlying immune response and an oral immunotherapy powder (Palforzia) recently discontinued by its manufacturer.2 The microneedle device, developed by Atlanta-based Moonlight Therapeutics, Inc., received FDA clearance for human testing in late 2025.¹

"With microneedles, the delivery system actually inserts the peanut proteins through the outer layers of skin, less than a millimeter deep, which may make it easier for the immune cells residing within the skin to interact with them,” Brian Vickery, MD, chief of allergy and immunology at Children's Healthcare of Atlanta, told 

. He said the mechanism may improve on epicutaneous patches, where peanut protein remains on the skin's surface rather than breaching the outer barrier.

The trial is designed as a phase 1 safety study, with dose selection for a future efficacy trial as a secondary goal. Participants receive an initial 1-microgram dose of peanut protein, a fraction of the roughly 300 mg contained in a single peanut kernel, applied under supervision in the research unit before discharge home the same day.

Each participant returns weekly for an escalating dose, moving from 5 micrograms to 10 micrograms and continuing in this pattern up to a ceiling of 100 micrograms if tolerated. Every application pairs an active stamp on 1 forearm with a placebo stamp on the other, allowing a within-patient comparison at each visit.¹ The ascending-dose approach reflects how patients with peanut allergy react across a wide range of thresholds, from those who tolerate moderate exposure to those sensitive to trace amounts.

The study is enrolling participants at 5 sites nationally: Children's and Emory University, the University of North Carolina at Chapel Hill, the University of Arkansas, the University of Michigan, and a clinical research organization in Nebraska.¹

What is the microneedle stamp designed to treat?


It delivers peanut protein immunotherapy through the skin as a potential treatment for peanut allergy, currently in a phase 1 safety trial.

How does the microneedle stamp differ from existing peanut allergy patches?


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.

What doses are being tested in the phase 1 trial?


The trial escalates from an initial 1-microgram dose of peanut protein up to a ceiling of 100 micrograms, administered weekly under clinical supervision.

Microneedle Stamp Safety Monitoring and At-Home Use Plans

Vickery said investigators are watching most closely for systemic allergic reactions, including anaphylaxis, the primary risk in any food immunotherapy program. More commonly expected are localized reactions at the application site, such as itching, redness, swelling, and hives, consistent with earlier immunotherapy platforms. The research team is prepared to manage reactions during in-clinic dosing visits, which take place under direct observation.

Home use is a goal for future development but is not part of the current protocol, Vickery said. The phase 1 study aims to identify a microgram-level dose low enough to avoid systemic symptoms with each individual application; investigators believe repeated dosing could shift over time to alter immune response.

“It's important that we accomplish [the safety] objective in this phase 1 study in order to ensure safe use at home by families in the future,” Vickery said. “I think we're a long way away from that. The next study is almost certainly going to have supervised exposure [again] in the research unit as we learn how this product works.

Wood R and Ross J. Palforzia Discontinued, Ending the Only FDA-Approved Peanut OIT Option. HCPLive. Published July 31, 2026. Accessed August 18, 2026. 

https://www.hcplive.com/view/palforzia-discontinued-ending-only-fda-approved-peanut-oit

The first-in-human study is testing an ascending-dose microneedle device designed to deliver peanut protein through the skin in just 3 minutes.