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Allergen\u2010specific immunotherapy is the only treatment shown to modify the natural history of allergic disease, but application to food allergy has been hindered by risk of severe allergic reactions and short\u2010lived efficacy. Allergen\u2010derived peptides could provide a solution. PVX108 comprises seven short peptides representing immunodominant T\u2010cell epitopes of major peanut allergens for treatment of peanut allergy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Pre\u2010clinical safety of PVX108 was assessed using ex\u00a0vivo basophil activation tests (<jats:italic>n<\/jats:italic>\u2009=\u2009185). Clinical safety and tolerability of single and repeat PVX108 doses were evaluated in a first\u2010in\u2010human, randomized, double\u2010blind, placebo\u2010controlled trial in peanut\u2010allergic adults (46 active, 21 placebo). The repeat\u2010dose cohort received six doses over 16\u2009weeks with safety monitored to 21\u2009weeks. Exploratory immunological analyses were performed at pre\u2010dose, Week 21 and Month 18 after treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>PVX108 induced negligible activation of peanut\u2010sensitised basophils. PVX108 was safe and well tolerated in peanut\u2010allergic adults. There were no treatment\u2010related hypersensitivity events or AEs of clinical concern. The only events occurring more frequently in active than placebo were mild injection site reactions. Exploratory immunological analyses revealed a decrease in the ratio of ST2<jats:sup>+<\/jats:sup> Th2A:CCR6<jats:sup>+<\/jats:sup> Th17\u2010like cells within the peanut\u2010reactive Th pool which strengthened following treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study supports the concept that PVX108 could provide a safe alternative to whole peanut immunotherapies and provides evidence of durable peanut\u2010specific T\u2010cell modulation. Translation of these findings to clinical efficacy in ongoing Phase 2 trials would provide important proof\u2010of\u2010concept for using peptides to treat food allergy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/all.15966","type":"journal-article","created":{"date-parts":[[2023,12,19]],"date-time":"2023-12-19T12:50:11Z","timestamp":1702990211000},"page":"485-498","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Phase 1 trial supports safety and mechanism of action of peptide immunotherapy for peanut allergy"],"prefix":"10.1111","volume":"79","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9389-5138","authenticated-orcid":false,"given":"Astrid L.","family":"Voskamp","sequence":"first","affiliation":[{"name":"Aravax Pty Ltd  Melbourne Victoria Australia"},{"name":"Monash University  Melbourne Victoria Australia"},{"name":"Alfred Health  Melbourne Victoria Australia"},{"name":"WhiteFox Science Consulting  Nelson New 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