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We aimed to investigate the efficacy of one\u2010year <jats:styled-content style=\"fixed-case\">AIT<\/jats:styled-content> with the folding variant (<jats:styled-content style=\"fixed-case\">FV<\/jats:styled-content>) of recombinant (r) Bet v 1 on birch\u2010related soya allergy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Of 138 subjects with Bet v 1 sensitization, 82 were positive at double\u2010blind placebo\u2010controlled food challenge (<jats:styled-content style=\"fixed-case\">DBPCFC<\/jats:styled-content>) with soya. A total of 56 of 82 were randomized in the ratio of 2:1 (active: placebo). Per\u2010protocol population (<jats:styled-content style=\"fixed-case\">PPP<\/jats:styled-content>) had received \u2265150 \u03bcg of allergen or placebo preparation. Outcome measures: lowest observed adverse effect levels (<jats:styled-content style=\"fixed-case\">LOAEL<\/jats:styled-content>), postinterventional occurrence of objective signs (objS) at any dose level, <jats:styled-content style=\"fixed-case\">sIgE<\/jats:styled-content>\/IgG4 against Bet v 1 and Gly m 4. Between\u2010group changes were investigated (<jats:sc>ancova<\/jats:sc>, Mann\u2013Whitney <jats:italic>U<\/jats:italic>\u2010test, Fisher exact test).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Baseline characteristics including <jats:styled-content style=\"fixed-case\">LOAEL<\/jats:styled-content>s were comparable in both groups with objS and subjS occurring in 82% and 95% of active (<jats:italic>n<\/jats:italic> = 38) <jats:italic>vs<\/jats:italic> 78% and 83% of placebo group (<jats:italic>n<\/jats:italic> = 18). After <jats:styled-content style=\"fixed-case\">AIT<\/jats:styled-content>, objS occurred in 24% and 47%, respectively. <jats:styled-content style=\"fixed-case\">LOAEL<\/jats:styled-content> group differences showed a beneficial tendency (<jats:italic>P<\/jats:italic> = 0.081) for <jats:styled-content style=\"fixed-case\">LOAEL<\/jats:styled-content><jats:sub>objective<\/jats:sub> in <jats:styled-content style=\"fixed-case\">PPP<\/jats:styled-content> (30 active, 15 placebo). <jats:styled-content style=\"fixed-case\">sIgG<\/jats:styled-content>4 raised only in active group (Bet v 1: <jats:italic>P<\/jats:italic> = 0.054, Gly m 4: <jats:italic>P<\/jats:italic> = 0.037), and no relevant changes occurred for <jats:styled-content style=\"fixed-case\">sIgE<\/jats:styled-content>. Only 56% of the intended sample size was recruited.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>For the first time, we present data on the effect of <jats:styled-content style=\"fixed-case\">rB<\/jats:styled-content>et v 1\u2010<jats:styled-content style=\"fixed-case\">FV<\/jats:styled-content> on birch\u2010related soya allergy. <jats:styled-content style=\"fixed-case\">rB<\/jats:styled-content>et v 1\u2010<jats:styled-content style=\"fixed-case\">FV AIT<\/jats:styled-content> induced significant immunogenic effects. Clinical assessment showed a tendency in favour of the active group but did not reach statistical significance.<\/jats:p><\/jats:sec>","DOI":"10.1111\/all.13112","type":"journal-article","created":{"date-parts":[[2016,12,21]],"date-time":"2016-12-21T00:03:00Z","timestamp":1482278580000},"page":"1243-1253","source":"Crossref","is-referenced-by-count":42,"title":["<scp>BASALIT<\/scp> trial: double\u2010blind placebo\u2010controlled allergen immunotherapy with <scp>rB<\/scp>et v 1\u2010<scp>FV<\/scp> in birch\u2010related soya allergy"],"prefix":"10.1111","volume":"72","author":[{"given":"R.","family":"Treudler","sequence":"first","affiliation":[{"name":"Department of Dermatology, Venerology and Allergology Universit\u00e4t Leipzig Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Franke","sequence":"additional","affiliation":[{"name":"Clinical Trial Centre Leipzig (ZKS) Universit\u00e4t Leipzig Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Schmiedeknecht","sequence":"additional","affiliation":[{"name":"Clinical Trial Centre Leipzig (ZKS) Universit\u00e4t Leipzig Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"Ballmer\u2010Weber","sequence":"additional","affiliation":[{"name":"Allergy Unit Department of Dermatology University Hospital Z\u00fcrich and Centre of Dermatology and Allergology Luzerner Kantonsspital Luzern Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Worm","sequence":"additional","affiliation":[{"name":"Allergy Center Charit\u00e9 Department of Dermatology, Venerology and Allergology Charit\u00e9 \u2010 Universit\u00e4tsmedizin Berlin Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Werfel","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology MH Hannover Hannover Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"U.","family":"Jappe","sequence":"additional","affiliation":[{"name":"Division of Clinical &amp; 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