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Clinical and Translational Allergy
Published in: Clinical and Translational Allergy 1/2015

Open Access 01-12-2015 | Brief communication

Allergy immunotherapy with a hypoallergenic recombinant birch pollen allergen rBet v 1-FV in a randomized controlled trial

Authors: Ludger Klimek, Claus Bachert, Karl-Friedrich Lukat, Oliver Pfaar, Hanns Meyer, Annemie Narkus

Published in: Clinical and Translational Allergy | Issue 1/2015

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Abstract

Background

Pollen extracts and chemically modified allergoids are used successfully in allergen immunotherapy (AIT). Recombinant extracts offer potential advantages with respect to pharmaceutical quality, standardization and dosing. A hypoallergenic recombinant folding variant of the major birch pollen allergen (rBet v 1-FV) was compared with an established native birch preparation. A pre-seasonal, randomized, actively controlled phase II study was performed in birch pollen allergic rhino-conjunctivitis with or without asthma, GINA I/ II. 51 patients (24 rBet v 1-FV, 27 native extract) started therapy with subcutaneous allergen immunotherapy (SCIT). Primary end-point was a combined symptom medication score (SMS), changes in nasal provocation test, visual rating score and specific antibody responses secondary end-points.

Findings

After one pre-seasonal treatment course the combined SMS was 5.86 (median; IQR: 14.02) for the rBet v 1-FV group versus 12.40 (median; IQR: 9.32) for the comparator during the three weeks pollen season (p = 0.330). After treatment in the second year, scores were 3.00 (median; IQR: 6.50) and 2.93 (4.86) respectively. Allergen tolerance in a nasal provocation test improved to a comparable extent in both groups. Significant increases in birch pollen-specific IgG1 and IgG4 were observed in both treatment groups following the first treatment phase and remained significantly raised until the end of the study.

Conclusion

In this first in man, proof of concept phase II trial no statistical difference between rBet v 1-FV and an established natural pollen extract could be observed. rBet v 1-FV could be administered in higher doses than the native protein with no increase in adverse effects.

Trial registration

The study was registered in clinicalTrials.gov (NCT00266526).
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Metadata
Title
Allergy immunotherapy with a hypoallergenic recombinant birch pollen allergen rBet v 1-FV in a randomized controlled trial
Authors
Ludger Klimek
Claus Bachert
Karl-Friedrich Lukat
Oliver Pfaar
Hanns Meyer
Annemie Narkus
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Clinical and Translational Allergy / Issue 1/2015
Electronic ISSN: 2045-7022
DOI
https://doi.org/10.1186/s13601-015-0071-x

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