Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites
Background: House dust mite (HDM) allergies are prevalent, yet current treatments like allergen avoidance, pharmacotherapy, and conventional allergen immunotherapy present limitations. The novel LAMP (lysosomal-associated membrane protein)-based DNA vaccine ASP2390 targets major HDM allergens, poten...
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Elsevier
2025-05-01
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| Series: | Journal of Allergy and Clinical Immunology: Global |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772829325000050 |
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| author | Thomas Kayser, MD, BS Ronald Smulders, MD, PhD Tomohiro Kusawake, PhD Erik Wambre, PhD Gurunadh R. Chichili, PhD Mary B. Blauwet, DrPH Anna Spence, MS Melanie Patton, BS Rima Tabash, PhD Hannah A. DeBerg, PhD Sugandhika Khosa, MS Philipp Badorrek, MD Jens M. Hohlfeld, MD Brian C. Ferslew, PharmD, PhD |
| author_facet | Thomas Kayser, MD, BS Ronald Smulders, MD, PhD Tomohiro Kusawake, PhD Erik Wambre, PhD Gurunadh R. Chichili, PhD Mary B. Blauwet, DrPH Anna Spence, MS Melanie Patton, BS Rima Tabash, PhD Hannah A. DeBerg, PhD Sugandhika Khosa, MS Philipp Badorrek, MD Jens M. Hohlfeld, MD Brian C. Ferslew, PharmD, PhD |
| author_sort | Thomas Kayser, MD, BS |
| collection | DOAJ |
| description | Background: House dust mite (HDM) allergies are prevalent, yet current treatments like allergen avoidance, pharmacotherapy, and conventional allergen immunotherapy present limitations. The novel LAMP (lysosomal-associated membrane protein)-based DNA vaccine ASP2390 targets major HDM allergens, potentially shifting immune responses toward nonallergic pathways and minimizing the risk of atopy, with positive safety and efficacy signals in preclinical models. Objective: We evaluated the safety, tolerability, and efficacy of first-in-human intradermal ASP2390 in adults with HDM allergy. Methods: A randomized, double-blind, placebo-controlled phase 1 trial was conducted in adults with HDM-induced allergic rhinitis. Participants received either 1 mg or 4 mg of ASP2390 or placebo intradermally once weekly for 12 weeks, with safety, tolerability, and pharmacodynamic responses assessed over a 63-week period, including early-phase clinical effects assessed via HDM exposure in an allergen challenge chamber. Results: Twenty-eight adults (mean age, 26.9 years; 23 male participants), with 7 receiving 1 mg and 13 receiving 4 mg ASP2390, 8 receiving placebo, showed no serious adverse events or withdrawals due to treatment-emergent adverse events. The most common events were nasopharyngitis, coronavirus disease 2019, headache, fatigue, and diarrhea; fatigue and headache were the most frequent systemic reactions, and injection-site tenderness the most frequent local reaction. There were no substantial changes in allergen-specific immunoglobulin levels, basophil activation, or T helper cell subpopulations, and no difference in allergic clinical responses compared to placebo. Conclusion: Intradermal DNA vaccine ASP2390 is safe and well tolerated but does not show an immunologic or clinical response in a small sample of adults allergic to HDM. |
| format | Article |
| id | doaj-art-f05feefc4024479685e196614ba60ff9 |
| institution | Kabale University |
| issn | 2772-8293 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Allergy and Clinical Immunology: Global |
| spelling | doaj-art-f05feefc4024479685e196614ba60ff92025-02-08T05:01:44ZengElsevierJournal of Allergy and Clinical Immunology: Global2772-82932025-05-0142100404Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mitesThomas Kayser, MD, BS0Ronald Smulders, MD, PhD1Tomohiro Kusawake, PhD2Erik Wambre, PhD3Gurunadh R. Chichili, PhD4Mary B. Blauwet, DrPH5Anna Spence, MS6Melanie Patton, BS7Rima Tabash, PhD8Hannah A. DeBerg, PhD9Sugandhika Khosa, MS10Philipp Badorrek, MD11Jens M. Hohlfeld, MD12Brian C. Ferslew, PharmD, PhD13Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, GermanyAstellas Pharma Global Development Inc, Northbrook, IllAstellas Pharma Inc, Tokyo, JapanBenaroya Research Institute at Virginia Mason, Seattle, WashAstellas Pharma Global Development Inc, Northbrook, IllAstellas Pharma Global Development Inc, Northbrook, IllAstellas Pharma Global Development Inc, Northbrook, IllAstellas Pharma Global Development Inc, Northbrook, IllAstellas Pharma Global Development Inc, Northbrook, IllBenaroya Research Institute at Virginia Mason, Seattle, WashBenaroya Research Institute at Virginia Mason, Seattle, WashFraunhofer Institute for Toxicology and Experimental Medicine, Hannover, GermanyFraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany; Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany; German Center for Lung Research (DZL), Biomedical Research in Endstage and Obstructive Lung Disease Hannover BREATH, Hannover, Germany; Corresponding authors: Jens M. Hohlfeld, MD, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Nikolai-Fuchs-Str 1, 30625 Hannover, Germany.Astellas Pharma Global Development Inc, Northbrook, Ill; Brian C. Ferslew, PharmD, PhD, Astellas Pharma Global Development Inc, 2375 Waterview Dr, Northbrook, IL 60062-6145.Background: House dust mite (HDM) allergies are prevalent, yet current treatments like allergen avoidance, pharmacotherapy, and conventional allergen immunotherapy present limitations. The novel LAMP (lysosomal-associated membrane protein)-based DNA vaccine ASP2390 targets major HDM allergens, potentially shifting immune responses toward nonallergic pathways and minimizing the risk of atopy, with positive safety and efficacy signals in preclinical models. Objective: We evaluated the safety, tolerability, and efficacy of first-in-human intradermal ASP2390 in adults with HDM allergy. Methods: A randomized, double-blind, placebo-controlled phase 1 trial was conducted in adults with HDM-induced allergic rhinitis. Participants received either 1 mg or 4 mg of ASP2390 or placebo intradermally once weekly for 12 weeks, with safety, tolerability, and pharmacodynamic responses assessed over a 63-week period, including early-phase clinical effects assessed via HDM exposure in an allergen challenge chamber. Results: Twenty-eight adults (mean age, 26.9 years; 23 male participants), with 7 receiving 1 mg and 13 receiving 4 mg ASP2390, 8 receiving placebo, showed no serious adverse events or withdrawals due to treatment-emergent adverse events. The most common events were nasopharyngitis, coronavirus disease 2019, headache, fatigue, and diarrhea; fatigue and headache were the most frequent systemic reactions, and injection-site tenderness the most frequent local reaction. There were no substantial changes in allergen-specific immunoglobulin levels, basophil activation, or T helper cell subpopulations, and no difference in allergic clinical responses compared to placebo. Conclusion: Intradermal DNA vaccine ASP2390 is safe and well tolerated but does not show an immunologic or clinical response in a small sample of adults allergic to HDM.http://www.sciencedirect.com/science/article/pii/S2772829325000050Allergen immunotherapyallergyASP2390clinical trialhouse dust miteimmunologic response |
| spellingShingle | Thomas Kayser, MD, BS Ronald Smulders, MD, PhD Tomohiro Kusawake, PhD Erik Wambre, PhD Gurunadh R. Chichili, PhD Mary B. Blauwet, DrPH Anna Spence, MS Melanie Patton, BS Rima Tabash, PhD Hannah A. DeBerg, PhD Sugandhika Khosa, MS Philipp Badorrek, MD Jens M. Hohlfeld, MD Brian C. Ferslew, PharmD, PhD Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites Journal of Allergy and Clinical Immunology: Global Allergen immunotherapy allergy ASP2390 clinical trial house dust mite immunologic response |
| title | Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites |
| title_full | Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites |
| title_fullStr | Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites |
| title_full_unstemmed | Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites |
| title_short | Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites |
| title_sort | phase 1 study of safety tolerability and efficacy of intradermal dna vaccine asp2390 in adults allergic to house dust mites |
| topic | Allergen immunotherapy allergy ASP2390 clinical trial house dust mite immunologic response |
| url | http://www.sciencedirect.com/science/article/pii/S2772829325000050 |
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