![](/assets/avatars/avatar-publication-b82d19bb2e3dcd30febf5ea64511884facd2f6698b7de16227b3e2c24ee35931.png)
BASALIT trial: double-blind placebo-controlled allergen immunotherapy with rBet v 1-FV in birch-related soya allergy.
![](/assets/famfamfam_silk/page_white_go-0c1d6fc52b0accc2a26565737a1bfabe02e1980e768701c88b225d100de96dad.png)
![](/assets/famfamfam_silk/script_go-0c2a24c19bb933b67d50a0308fce8173ab85f681ae3cbbb91060e34cdf5c6254.png)
BACKGROUND: Conflicting results exist on the effect of allergen immunotherapy (AIT) on pollen-related food allergy. We aimed to investigate the efficacy of one-year AIT with the folding variant (FV) of recombinant (r) Bet v 1 on birch-related soya allergy. METHODS: Of 138 subjects with Bet v 1 sensitization, 82 were positive at double-blind placebo-controlled food challenge (DBPCFC) with soya. A total of 56 of 82 were randomized in the ratio of 2:1 (active: placebo). Per-protocol population (PPP) had received >/=150 mug of allergen or placebo preparation. OUTCOME MEASURES: lowest observed adverse effect levels (LOAEL), postinterventional occurrence of objective signs (objS) at any dose level, sIgE/IgG4 against Bet v 1 and Gly m 4. Between-group changes were investigated (ancova, Mann-Whitney U-test, Fisher exact test). RESULTS: Baseline characteristics including LOAELs were comparable in both groups with objS and subjS occurring in 82% and 95% of active (n = 38) vs 78% and 83% of placebo group (n = 18). After AIT, objS occurred in 24% and 47%, respectively. LOAEL group differences showed a beneficial tendency (P = 0.081) for LOAEL(objective) in PPP (30 active, 15 placebo). sIgG4 raised only in active group (Bet v 1: P = 0.054, Gly m 4: P = 0.037), and no relevant changes occurred for sIgE. Only 56% of the intended sample size was recruited. CONCLUSION: For the first time, we present data on the effect of rBet v 1-FV on birch-related soya allergy. rBet v 1-FV AIT induced significant immunogenic effects. Clinical assessment showed a tendency in favour of the active group but did not reach statistical significance.
Human Diseases: No Human Disease specified
Citation: Allergy. 2017 Aug;72(8):1243-1253. doi: 10.1111/all.13112. Epub 2017 Jan 17.
Date Published: 21st Dec 2016
Registered Mode: by PubMed ID
![help](/assets/famfamfam_silk/information-ff9c48d8c2d063932c7aadd5e15ddfdc76b7111bf0715f3a192bba26df2c531c.png)
Views: 1169
Created: 22nd Mar 2023 at 15:06
![help](/assets/famfamfam_silk/information-ff9c48d8c2d063932c7aadd5e15ddfdc76b7111bf0715f3a192bba26df2c531c.png)
This item has not yet been tagged.
![help](/assets/famfamfam_silk/information-ff9c48d8c2d063932c7aadd5e15ddfdc76b7111bf0715f3a192bba26df2c531c.png)
None