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.
  
  
  CONCLUSIONS
  The rBet v 1-based vaccine was safe and effective in treating birch pollen allergy, and induced a highly specific immune response.
authors.affiliation: University Hospital, Strasbourg, France.
authors.forename: Gabrielle
authors.initials: G
authors.lastname: Pauli
authors.forename: Tina H
authors.initials: TH
authors.lastname: Larsen
authors.forename: Sabina
authors.initials: S
authors.lastname: Rak
authors.forename: Friedrich
authors.initials: F
authors.lastname: Horak
authors.forename: Elide
authors.initials: E
authors.lastname: Pastorello
authors.forename: Rudolf
authors.initials: R
authors.lastname: Valenta
authors.forename: Rudolph
authors.initials: R
authors.lastname: Valenta
authors.forename: Ashok
authors.initials: A
authors.lastname: Purohit
authors.forename: Monica
authors.initials: M
authors.lastname: Arvidsson
authors.forename: Alexander
authors.initials: A
authors.lastname: Kavina
authors.forename: Jan W
authors.initials: JW
authors.lastname: Schroeder
authors.forename: Nadine
authors.initials: N
authors.lastname: Mothes
authors.forename: Susanne
authors.initials: S
authors.lastname: Spitzauer
authors.forename: Armelle
authors.initials: A
authors.lastname: Montagut
authors.forename: Sylvie
authors.initials: S
authors.lastname: Galvain
authors.forename: Michel
authors.initials: M
authors.lastname: Melac
authors.forename: Claude
authors.initials: C
authors.lastname: André
authors.forename: Lars K
authors.initials: LK
authors.lastname: Poulsen
authors.forename: Hans-Jorgen
authors.initials: HJ
authors.lastname: Malling
mesh_terms: D000328:Adult; D000485:Allergens / Q000009:adverse effects / Q000276:immunology*; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D029662:Betula / Q000009:adverse effects / Q000276:immunology*; D003233:Conjunctivitis, Allergic / Q000276:immunology / Q000628:therapy*; D003888:Desensitization, Immunologic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011058:Pollen / Q000009:adverse effects / Q000276:immunology*; D011994:Recombinant Proteins / Q000276:immunology / Q000627:therapeutic use; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000628:therapy*; D014612:Vaccines / Q000276:immunology / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000485:Allergens; D018926:Anti-Allergic Agents; D011994:Recombinant Proteins; D014612:Vaccines