BM32 is a product for immunotherapy of grass pollen allergies. It consists of 4 different recombinant proteins (BM321, BM322, BM325 and BM326) adsorbed on alhydrogel. This prospective, double-blind. placebo controlled, mono-centric trial investigates the levels of allergen specific IgG antibodies following 3, 4 or 5 subcutaneous injections before the grass pollen season.
The aim of this study is to further optimize the immunization schedule by * moving the last injection into beginning of the grass pollen season for all study arms in order to ensure highest possible IgG4 levels when they are needed - i.e. at the peak of the grass pollen season, * administration of more than 3 pre-seasonal injections in order to build up sufficiently high levels of IgG4 already in the first year of treatment , and * dosing during the beginning of the grass pollen season to establish safety in this setting The effect of such optimized immunization schedule on the induction of an IgG4 immune response as a surrogate parameter for efficacy will be studied. The Total Nasal Symptom Score (TNSS) before and after the treatment and Combined Symptom-Medication Score (SMS) during the grass pollen season will be evaluated as secondary endpoints. This will allow intra-individual comparison of seasonal symptom data and responsiveness in the chamber setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
Vienna Challenge Chamber
Vienna, Vienna, Austria
Titer of allergen specific IgG4 antibodies
Time frame: approximately 6 months
Total nasal symptom score upon pollen challenge (TNSS)
Sensitivity to a grass pollen challenge in an environmental exposure chamber
Time frame: Change from baseline at 9 months
Mean daily combined symptom and medication score (SMS)
Time frame: 2 weeks
Well-being via visual analog scale
Time frame: 2 weeks
Titers of allergen specific IgG antibodies
Time frame: Up to 9 months
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