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 μg 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.

Efficacy of recombinant birch pollen vaccine for the treatment of birch allergic rhinoconjunctivitis / G. Pauli, T.H. Larsen, S. Rak, F. Horak, E. Pastorello, R. Valenta, A. Purohit, M. Arvidsson, A. Kavina, J. Schroeder, N. Mothes, S. Spitzauer, A. Montagut, S. Galvain, M. Melac, C. André, L.K. Poulsen, H.J. Malling. - In: JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. - ISSN 0091-6749. - 122:5(2008), pp. 951-960. [10.1016/j.jaci.2008.09.017]

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

E. Pastorello;
2008

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 μg 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.
Settore MED/09 - Medicina Interna
2008
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/71136
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