{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T01:52:16Z","timestamp":1790992336071,"version":"4.1.0"},"reference-count":60,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T00:00:00Z","timestamp":1788480000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T00:00:00Z","timestamp":1788480000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Allergy"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      We have recently reported the preclinical characterization of a recombinant birch pollen allergy vaccine based on a fusion protein,\n                      <jats:styled-content style=\"fixed-case\">AB<\/jats:styled-content>\n                      \u2010\n                      <jats:styled-content style=\"fixed-case\">PreS<\/jats:styled-content>\n                      , consisting of allergen\u2010derived peptides fused to the hepatitis B virus (\n                      <jats:styled-content style=\"fixed-case\">HBV<\/jats:styled-content>\n                      )\u2010derived\n                      <jats:styled-content style=\"fixed-case\">PreS<\/jats:styled-content>\n                      surface protein as immunological carrier.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      To investigate in a clinical study the usefulness of the\n                      <jats:styled-content style=\"fixed-case\">AB<\/jats:styled-content>\n                      \u2010\n                      <jats:styled-content style=\"fixed-case\">PreS<\/jats:styled-content>\n                      vaccine, termed\n                      <jats:styled-content style=\"fixed-case\">GNR<\/jats:styled-content>\n                      \u2010127, for allergen\u2010specific immunotherapy of birch pollen allergy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Stage 1 of the study, an open\u2010label Phase I study, determined among three doses (20\u2009\u03bcg:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20096; 40\u2009\u03bcg:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20096; 80\u2009\u03bcg:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20096) administered as Aluminum\u2010hydroxide\u2010adsorbed vaccines subcutaneously five times in monthly intervals, the highest tolerated doses. In the following Stage 2, randomized patients (placebo:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200945; 40\u2009\u03bcg:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200943; 80\u2009\u03bcg:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200944) received in a single\u2010blind, placebo\u2010controlled Phase II study monthly up to five pre\u2010seasonal injections. Safety monitoring followed the Medical Dictionary for Regulatory Activities (MedDRA); efficacy parameters were determined according to the European Academy for Allergy and Clinical Immunology (\n                      <jats:styled-content style=\"fixed-case\">EAACI<\/jats:styled-content>\n                      ) guidelines; allergen\u2010specific antibodies and basophil sensitivity were determined by\n                      <jats:styled-content style=\"fixed-case\">ELISA<\/jats:styled-content>\n                      and basophil activation testing, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A dose\u2010dependent reduction of the combined symptom medication score (\n                      <jats:styled-content style=\"fixed-case\">CSMS<\/jats:styled-content>\n                      ) (40\u2009\u03bcg: 17.41%; 80\u2009\u03bcg: 24.13%) over placebo was observed which was significant for the 80\u2009\u03bcg group and accompanied by the strongest induction of Bet v 1\u2010specific\n                      <jats:styled-content style=\"fixed-case\">IgG<\/jats:styled-content>\n                      (median 20\u2010fold increase) and a blunting of the seasonally boosted\n                      <jats:styled-content style=\"fixed-case\">IgE<\/jats:styled-content>\n                      response and basophil sensitivity. The vaccine showed an acceptable safety profile despite high administered doses.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      A pre\u2010seasonal course of 5 monthly injections of\n                      <jats:styled-content style=\"fixed-case\">GNR<\/jats:styled-content>\n                      \u2010127 80\u2009\u03bcg improved symptoms of birch pollen allergy accompanied by a robust Bet v 1\u2010specific\n                      <jats:styled-content style=\"fixed-case\">IgG<\/jats:styled-content>\n                      response, paving the road for a Phase III efficacy study.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      (Identifier: NCT07155499)\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/all.70504","type":"journal-article","created":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T12:09:31Z","timestamp":1788523771000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pre\u2010Seasonal Treatment With Recombinant Carrier\u2010Based Birch Vaccine Improves Birch Pollen Allergy"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4961-9640","authenticated-orcid":false,"given":"Musa R.","family":"Khaitov","sequence":"first","affiliation":[{"name":"National Research Center Institute of Immunology FMBA of Russia  Moscow Russian Federation"},{"name":"Pirogov Russian National Research Medical University  Moscow Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9858-7596","authenticated-orcid":false,"given":"Maria G.","family":"Byazrova","sequence":"additional","affiliation":[{"name":"National Research Center Institute of Immunology FMBA of Russia  Moscow Russian Federation"},{"name":"Peoples' Friendship University of Russia (RUDN University) of Ministry of Science and Higher Education of the Russian Federation  Moscow Russian Federation"},{"name":"Life Improvement by Future Technologies (LIFT) Center  Moscow Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1302-4178","authenticated-orcid":false,"given":"Evgenii V.","family":"Smolnikov","sequence":"additional","affiliation":[{"name":"National Research Center Institute of Immunology FMBA of Russia  Moscow Russian Federation"},{"name":"Peoples' Friendship University of Russia (RUDN University) of Ministry of Science and Higher Education of the Russian Federation  Moscow Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1817-0844","authenticated-orcid":false,"given":"Vladislav N.","family":"Turenko","sequence":"additional","affiliation":[{"name":"National Research Center Institute of Immunology FMBA of Russia  Moscow Russian Federation"},{"name":"Institute of Pharmacy n. a. 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