| Clinical effects of immunotherapy with genetically modified recombinant birch pollen Bet v 1 derivatives. | |
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MedLine Citation:
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PMID: 18564326 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Birch pollen and pollen from related trees of the Fagales order are a major cause of allergic rhinitis, conjunctivitis, and asthma through the spring season in northern and central Europe. OBJECTIVE: To investigate the clinical effects of injection immunotherapy with genetically modified derivatives of major birch pollen allergen Bet v 1 on pollen-induced allergic symptoms. METHODS: A three-arm double-blind placebo-controlled immunotherapy study was conducted with one pre-seasonal course of treatment using two derivatives of Bet v 1, namely a recombinant Bet v 1 trimer and an equimolar mixture of two recombinant Bet v 1 fragments together representing the whole protein sequence. Analysis of local and systemic adverse events was performed for 124 patients who had received at least one dose of medication. Clinical efficacy was monitored by symptom medication scores and interval scoring in the per protocol-treated population (n=84). In addition, skin and nasal provocation responses and allergen-specific antibodies were assessed. RESULTS: There were trends towards improvement in the subjects' well-being and clinical symptoms (nasal scores), although comparisons with a placebo group did not show statistical significance in the main end-point, the combined symptom medication score. Reductions in skin and nasal sensitivity were observed for some subjects with a trend for the Bet v 1 trimer to be more effective than the fragments. Treatment induced strong IgG1 and IgG4 allergen-specific antibody responses. Local injection-site reactions were most frequent in the trimer group affecting 59.5% of patients as opposed to 37.8% and 30.6% in the fragment and placebo groups, respectively. Systemic reactions were elicited more frequently by fragments. A large proportion of adverse side-effects appeared hours following injections, and might be attributable to concurrent exposure to related pollens. CONCLUSION: Single courses of injection immunotherapy with Bet v 1 allergen derivatives showed trends towards improved well-being and reduced reactivity to specific allergen provocation, but did not yield significant improvement in the combined symptom medication score in this study. |
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Authors:
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A Purohit; V Niederberger; M Kronqvist; F Horak; R Grönneberg; R Suck; B Weber; H Fiebig; M van Hage; G Pauli; R Valenta; O Cromwell |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2008-06-28 |
Journal Detail:
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Title: Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology Volume: 38 ISSN: 1365-2222 ISO Abbreviation: Clin. Exp. Allergy Publication Date: 2008 Sep |
Date Detail:
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Created Date: 2008-10-10 Completed Date: 2009-01-22 Revised Date: 2011-06-21 |
Medline Journal Info:
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Nlm Unique ID: 8906443 Medline TA: Clin Exp Allergy Country: England |
Other Details:
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Languages: eng Pagination: 1514-25 Citation Subset: IM |
Affiliation:
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Service de Pneumologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Antigens, Plant / genetics, immunology, therapeutic use* Betula / immunology* Desensitization, Immunologic Double-Blind Method Female Humans Hypersensitivity / immunology, therapy* Immunoglobulin G / immunology Immunotherapy Male Middle Aged Pollen / immunology* Recombinant Proteins / genetics, immunology Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Antigens, Plant; 0/Immunoglobulin G; 0/Recombinant Proteins |
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