# Treatment of Peanut Allergy with Intradermal Administration of ASP0892 (ARA-LAMP-vax): A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study

> **NIH NIH UM2** · JOHNS HOPKINS UNIVERSITY · 2021 · $1,000,001

## Abstract

Summary
Despite significant advances in the development of potential treatments for food allergy, the approaches studied
thus far have been limited by insufficient clinical responses and/or high rates of adverse reactions. While
sublingual and epicutaneous immunotherapy (SLIT and EPIT) appear relatively safe, clinical responses have
been disappointing, whereas with oral immunotherapy (OIT) more robust clinical responses come at the price of
more frequent and severe adverse reactions. Further, it is clear that the benefits achieved with these treatments
are usually not long lasting, reflecting a transient desensitization rather than any form of longer term tolerance,
such that they will in all likelihood need to be used indefinitely to maintain protection.
The ideal treatment will have a low risk of adverse reactions, a high rate of desensitization, a substantial level of
protection, AND effects that will be truly sustained. Of the new modalities under current study, the most promising
candidate to achieve these goals is ASP0892 (ARA-LAMP-vax). This novel compound is a single plasmid
multivalent (Ara h1, h2, h3) lysosomal associated membrane (LAMP) DNA vaccine that is designed to radically
shift the immune response to peanut allergens in sensitized patients. In brief, DNA encoding the peanut allergens
Ara h1, h2 and h3 are inserted in tandem in a single plasmid containing the coding sequence for LAMP. Upon
intradermal or intramuscular administration, uptake of the plasmid by antigen presenting cells results in the
synthesis of an allergen-LAMP fusion protein. The LAMP component directs the fusion protein to cellular
lysosomes where the allergen is processed and added to major histocompatability complex (MHC)-II antigens,
which then stimulate a CD4+ helper T-cell response. Given that the peptide allergen is not released from the
antigen presenting cells, it is anticipated that these immunoregulatory effects can be achieved with minimal or no
risk of systemic allergic reactions to the vaccine.
The central hypothesis of this protocol is that this novel immunotherapeutic approach, utilizing the LAMP
associated plasmid DNA vaccine, will provide a safe, effective and long-lasting treatment for peanut allergy, with
a long term goal of developing the next generation of immunotherapy for peanut and other food allergies.

## Key facts

- **NIH application ID:** 10124274
- **Project number:** 5UM2AI130836-05
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** ROBERT A WOOD
- **Activity code:** UM2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,000,001
- **Award type:** 5
- **Project period:** 2017-03-01 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10124274

## Citation

> US National Institutes of Health, RePORTER application 10124274, Treatment of Peanut Allergy with Intradermal Administration of ASP0892 (ARA-LAMP-vax): A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study (5UM2AI130836-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10124274. Licensed CC0.

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