The study will evaluate the dose response of immunotherapy against grass pollen allergy using the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by: * skin prick testing * grass pollen inhalation challenge * antibody responses. In addition, the safety of subcutaneous application of BM32 will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
Subcutaneous injection of 10 micrograms each of the BM32 components adsorbed on 0.3 mg of aluminum hydroxide every 4 week for a total of 3 injections
Subcutaneous injection of 20 micrograms of each of the BM32 components adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections
Subcutaneous injection of 40 micrograms of each of the BM32 components adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks until a total of 3 injections
Allergy Center Vienna West
Vienna, Vienna, Austria
Minimum effective dose for reduction of total nasal symptom score (TNSS) after inhalation challenge with grass pollen
Difference in the total Nasal Symptom Score (TNSS) between spending 6 hrs in the Vienna Challenge Chamber (VCC) at screening and spending 6 hrs in the VCC four weeks after the last subcutaneous injection of BM32.
Time frame: Baseline and 14 weeks
Minimum Effective dose for reduction of Total Non-Nasal Symptom Score (TNNSS) following inhalation challenge with grass pollen
Time frame: Baseline and 14 weeks
Minimum effective dose for reduction of Global symptom Score upon inhalation challenge with grass pollen
Time frame: Baseline and 4 weeks after final s.c. injection
Minimum effective dose for reduction of nasal airflow resistance after inhalation challenge with grass pollen
Time frame: Baseline and 14 weeks
Minimum effective dose to reduce skin reaction to grass pollen allergen upon skin prick testing
Time frame: Baseline and 14 weeks
Difference in FEV1 and FEV/FVC between screening and completion of vaccination
Time frame: Baseline and 14 weeks
Frequency of local reactions to treatment
Time frame: average of 8 weeks from 1st to last injection
Change in allergy specific total IgG
Time frame: Baseline and average of 12 weeks after randomization
Change in allergy specific IgE
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections
Time frame: Baseline and average of 12 weeks after randomization
Frequency of systemic reactions to treatment
Time frame: average of 8 weeks from 1st to last injection
Severity of local reactions to treatment
Time frame: Average of 8 weeks from 1st to last injection
Severity of systemic reactions to treatment
Time frame: Average of 8 weeks from 1st to last injection
Frequency of adverse events
Time frame: average of 14 weeks from 1st injection