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

Gabrielle Pauli; Tina H Larsen; Sabina Rak; Friedrich Horak; Elide Pastorello; Rudolf Valenta; 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-Jørgen Malling

doi:10.1016/j.jaci.2008.09.017

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

Gabrielle Pauli, Tina H Larsen, Sabina Rak, Friedrich Horak, Elide Pastorello, Rudolf Valenta, 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-Jørgen Malling

Department of Clinical Medicine

246 Citations (Scopus)

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.

Original language	English
Journal	Journal of Allergy and Clinical Immunology
Volume	122
Issue number	5
Pages (from-to)	951-60
Number of pages	10
ISSN	0091-6749
DOIs	https://doi.org/10.1016/j.jaci.2008.09.017
Publication status	Published - 2008

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10.1016/j.jaci.2008.09.017

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Pauli, G., Larsen, T. H., Rak, S., Horak, F., Pastorello, E., Valenta, R., Valenta, R., Purohit, A., Arvidsson, M., Kavina, A., Schroeder, J. W., Mothes, N., Spitzauer, S., Montagut, A., Galvain, S., Melac, M., André, C., Poulsen, L. K., & Malling, H-J. (2008). Efficacy of recombinant birch pollen vaccine for the treatment of birch-allergic rhinoconjunctivitis. Journal of Allergy and Clinical Immunology, 122(5), 951-60. https://doi.org/10.1016/j.jaci.2008.09.017

Pauli, G, Larsen, TH, Rak, S, Horak, F, Pastorello, E, Valenta, R, Valenta, R, Purohit, A, Arvidsson, M, Kavina, A, Schroeder, JW, Mothes, N, Spitzauer, S, Montagut, A, Galvain, S, Melac, M, André, C, Poulsen, LK & Malling, H-J 2008, 'Efficacy of recombinant birch pollen vaccine for the treatment of birch-allergic rhinoconjunctivitis', Journal of Allergy and Clinical Immunology, vol. 122, no. 5, pp. 951-60. https://doi.org/10.1016/j.jaci.2008.09.017

@article{f85d11d0785011df928f000ea68e967b,

title = "Efficacy of recombinant birch pollen vaccine for the treatment of birch-allergic rhinoconjunctivitis",

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.",

author = "Gabrielle Pauli and Larsen, {Tina H} and Sabina Rak and Friedrich Horak and Elide Pastorello and Rudolf Valenta and Rudolph Valenta and Ashok Purohit and Monica Arvidsson and Alexander Kavina and Schroeder, {Jan W} and Nadine Mothes and Susanne Spitzauer and Armelle Montagut and Sylvie Galvain and Michel Melac and Claude Andr{\'e} and Poulsen, {Lars K} and Hans-J{\o}rgen Malling",

note = "Keywords: Adult; Allergens; Anti-Allergic Agents; Betula; Conjunctivitis, Allergic; Desensitization, Immunologic; Double-Blind Method; Female; Humans; Male; Middle Aged; Pollen; Recombinant Proteins; Rhinitis, Allergic, Seasonal; Vaccines; Young Adult",

year = "2008",

doi = "10.1016/j.jaci.2008.09.017",

language = "English",

volume = "122",

pages = "951--60",

journal = "Journal of Allergy and Clinical Immunology",

issn = "0091-6749",

publisher = "Mosby Inc.",

number = "5",

}

TY - JOUR

T1 - Efficacy of recombinant birch pollen vaccine for the treatment of birch-allergic rhinoconjunctivitis

AU - Pauli, Gabrielle

AU - Larsen, Tina H

AU - Rak, Sabina

AU - Horak, Friedrich

AU - Pastorello, Elide

AU - Valenta, Rudolf

AU - Valenta, Rudolph

AU - Purohit, Ashok

AU - Arvidsson, Monica

AU - Kavina, Alexander

AU - Schroeder, Jan W

AU - Mothes, Nadine

AU - Spitzauer, Susanne

AU - Montagut, Armelle

AU - Galvain, Sylvie

AU - Melac, Michel

AU - André, Claude

AU - Poulsen, Lars K

AU - Malling, Hans-Jørgen

N1 - Keywords: Adult; Allergens; Anti-Allergic Agents; Betula; Conjunctivitis, Allergic; Desensitization, Immunologic; Double-Blind Method; Female; Humans; Male; Middle Aged; Pollen; Recombinant Proteins; Rhinitis, Allergic, Seasonal; Vaccines; Young Adult

PY - 2008

Y1 - 2008

N2 - 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.

AB - 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.

U2 - 10.1016/j.jaci.2008.09.017

DO - 10.1016/j.jaci.2008.09.017

M3 - Journal article

C2 - 19000581

SN - 0091-6749

VL - 122

SP - 951

EP - 960

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

IS - 5

ER -

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

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