Specific subcutaneous immunotherapy with recombinant grass pollen allergens: first randomized dose-ranging safety study
Article first published online: 23 MAY 2012
© 2012 Blackwell Publishing Ltd
Clinical & Experimental Allergy
Volume 42, Issue 6, pages 936–945, June 2012
How to Cite
Cite this as: L. Klimek, P. Schendzielorz, R. Pinol and O. Pfaar, Clinical & Experimental Allergy, 2012 (42) 936–945.
- Issue published online: 23 MAY 2012
- Article first published online: 23 MAY 2012
- Accepted manuscript online: 31 JAN 2012 11:25AM EST
- Manuscript Accepted: 18 JAN 2012
- Manuscript Revised: 15 JAN 2012
- Manuscript Received: 1 JUL 2011
- Cytos Biotechnology
- dose-ranging safty study;
- Phleum pratense;
- recombinant allergens;
- subcutaneous immunotherapy
Allergen-specific immunotherapy (SIT) with native allergen extracts and allergoids has been performed successfully for decades. Preliminary studies revealed the use of recombinant allergen-preparations as a promising option for SIT.
The present study was designed to investigate the dose-ranging safety in SCIT with a mixture of five recombinant grass pollen allergens containing equimolar amounts of rPhl p 1, rPhl p2, rPhl p 5a, rPhl p 5b and rPhl p 6, adsorbed to aluminium hydroxide.
A randomized, double blind, placebo-controlled, dose-ranging safety study (EudraCT number 2007-002808-18) was performed in 50 patients with allergic rhinoconjunctivitis, with or without asthma. Patients were randomized to groups of 10 to receive maximum doses of 20, 40, 80 or 120 μg of total grass pollen recombinant protein or placebo.
The primary end-point of this trial was the number of patients with at least one systemic reaction with possible, probable or definite relationship to the study medication determined at the end of the up-dosing phase. Secondary end-points included titrated intracutaneous test with natural six-grass pollen extract, allergen-specific conjunctival provocation test as well as IgG and IgE-levels throughout the study.
Eight of the 50 patients revealed systemic reactions grade 1 or 2 corresponding to the primary end-point definition. No systemic reactions grade 3 or 4 occurred in any dosage group. The systemic reactions were well distributed among the active groups. Results of secondary end-points imply that the study medication is effective and provokes immunological effects.
Conclusions and Clinical Relevance
The first DBPC SCIT-DRF with a mixture of recombinant Phleum allergens (Phl p 1, 2, 5a, 5b, 6) in patients with rhinoconjunctivitis plus/minus asthma showed no major side effects in very high doses up to 120 μg.