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Efficacy of recombinant birch pollen vaccine for the treatment of birch-allergic rhinoconjunctivitis.

Journal article
Authors Gabrielle Pauli
Tina H Larsen
Sabina Rak
Friedrich Horak
Elide Pastorello
Rudolph Valenta
Ashok Purohit
Monica Arvidsson
Alexander Kavina
Jan W Schroeder
Nadine Mothes
Susanne Spitzauer
Armelle Montagut
Sylvie Galvain
Michel Melac
Claude André
Lars K Poulsen
Hans-Jorgen Malling
Published in The Journal of allergy and clinical immunology
Volume 122
Issue 5
Pages 951-60
ISSN 1097-6825
Publication year 2008
Published at Institute of Medicine, Department of Internal Medicine
Pages 951-60
Language en
Links dx.doi.org/10.1016/j.jaci.2008.09.0...
Keywords Adult, Allergens, adverse effects, immunology, Anti-Allergic Agents, therapeutic use, Betula, adverse effects, immunology, Conjunctivitis, Allergic, immunology, therapy, Desensitization, Immunologic, Double-Blind Method, Female, Humans, Male, Middle Aged, Pollen, adverse effects, immunology, Recombinant Proteins, immunology, therapeutic use, Rhinitis, Allergic, Seasonal, immunology, therapy, Vaccines, immunology, therapeutic use, Young Adult
Subject categories Medical and Health Sciences, Dermatology and Venereal Diseases

Abstract

BACKGROUND: Recombinant DNA technology has the potential to produce allergen-specific immunotherapy vaccines with defined composition. OBJECTIVE: To evaluate the effectiveness of a new recombinant birch pollen allergen vaccine in patients with birch pollen allergy. METHODS: A multicenter, randomized, double-blind, placebo-controlled trial was undertaken to compare the following 3 vaccines in 134 adults with birch pollen allergy: recombinant birch pollen allergen vaccine (rBet v 1a), licensed birch pollen extract, natural purified birch pollen allergen (nBet v 1), and placebo. Patients received 12 weekly injections followed by monthly injections of the maintenance dose containing 15 microg Bet v 1 for 2 years. RESULTS: Significant reductions (about 50%) in rhinoconjunctivitis symptoms (rBet v 1, P = .0002; nBet v 1, P = .0006; birch extract, P = .0024), rescue medication (rBet v 1, P = .0011; nBet v 1, P = .0025; birch extract, P = .0063), and skin sensitivities (P < .0001) were observed in the 3 actively treated groups compared with placebo during 2 consecutive pollen seasons. Clinical improvement was accompanied by marked increases in Bet v 1-specific IgG levels, which were higher in the rBet v 1-treated group than in the birch and nBet v 1-treated groups. New IgE specificities were induced in 3 of 29 patients treated with birch pollen extract, but in none of the 32 rBet v 1-treated or 29 nBet v 1-treated patients. No severe systemic adverse events were observed in the rBet v 1-treated group. CONCLUSION: The rBet v 1-based vaccine was safe and effective in treating birch pollen allergy, and induced a highly specific immune response.

Page Manager: Webmaster|Last update: 9/11/2012
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