Efficacy of recombinant birch pollen vaccine for the treatment of birch-allergic rhinoconjunctivitis.
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.
Pauli
Gabrielle
G
University Hospital, Strasbourg, France.
Larsen
Tina H
TH
Rak
Sabina
S
Horak
Friedrich
F
Pastorello
Elide
E
Valenta
Rudolf
R
Valenta
Rudolph
R
Purohit
Ashok
A
Arvidsson
Monica
M
Kavina
Alexander
A
Schroeder
Jan W
JW
Mothes
Nadine
N
Spitzauer
Susanne
S
Montagut
Armelle
A
Galvain
Sylvie
S
Melac
Michel
M
André
Claude
C
Poulsen
Lars K
LK
Malling
Hans-Jorgen
HJ
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
D000485:Allergens; D018926:Anti-Allergic Agents; D011994:Recombinant Proteins; D014612:Vaccines