The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off allergy symptoms over a two year study period.
The present study is designed to evaluate the efficacy and safety of a treatment with the recombinant vaccine BM32 during two consecutive grass pollen seasons. Efficacy evaluation will be performed on the basis of allergy symptoms and use of relief medication as well as based on immunological parameters. After patient assessment during a screening season, patients will be randomized to one of two doses of BM32 or placebo. Patients will receive three injections of BM32 pre-season and one post-season boost injection to maintain optimal allergen specific IgG responses. Outcome will be measured after both seasons individually.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
181
Subcutaneous injection of 20 micrograms of each of the protein components of BM32 adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season
Subcutaneous injection of 40 micrograms of each of the protein components of BM32 adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season
Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every four weeks before each pollen season and one injection after pollen season for a total of 7 injections
Medical University
Vienna, State of Vienna, Austria
Universitätsklinik für Dermatologie und Allergologie
Graz, Austria
Allergy Network Ghent University Hospital Ghent, Dept. Otorhiolaryngologie
Ghent, Belgium
Mean daily combined symptom medication score (SMS)during the peak of the pollen season.
The score will be recorded daily for the 30-45 days with the highest pollen count in each center
Time frame: Up to 3 months
Vital functions
Time frame: Up to 22 months
Safety laboratory hematology
Time frame: up to 22 months
Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season
The VAS will be recorded daily during the grass pollen seasons of 2013 and 2014
Time frame: Up to 8 months
Number of "bad days" during the peak pollen season and the whole pollen season
The number of bad days will be recorded daily during the grass pollen seasons of 2013 and 2014
Time frame: Up to 8 months
Number of symptom-free days during the peak pollen season and the whole pollen season
The mesure will be recorded daily during the grass pollen seasons of 2013 and 2014
Time frame: Up to 8 months
Rhinoconjunctivitis quality of life evaluation by RQLQ questionnaire during pollen season
The questionnaire will be completed on a weekly basis during the pollen seasons of 2013 and 2014.
Time frame: Approx. 22 months
Mean asthma score during pollen season
The score will be recorded on a daily basis duirng the pollen seasons of 2013 and 2014
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Allergy Clinic Copenhagen University Hospital at Gentofte
Hellerup, Denmark
Department of Dermatology and Allergology Am Biederstein TU Munich
Munich, Bavaria, Germany
Allergiezentrum Charite
Berlin, Germany
Klinik und Poliklnik für Dermatologie und Allergologie der Universität Bonn
Bonn, Germany
Dept. of Dermatology and Allergology University Medical Center Gieseen and Mrbaurg GmbH
Marburg, Germany
Zentrum für Rhinologie/Allergologie
Wiesbaden, Germany
Dept. of Internal Medicine Erasmus Medical Center
Rotterdam, Netherlands
...and 1 more locations
Time frame: Up to 8 months
Mean allergy specific IgG and IgE antibodies before and after vaccination
These antibody levels will be recorded a total of five times (01/2013, 04/2013, 09/2013, 01/2014 and 04/2014)
Time frame: Up to 16 months
Mean daily symptom and medication score during the whole pollen season
The score will be recorded daily approximately during May 2013 - August 2013 and May 2014 - August 2014
Time frame: Up to 8 months
Mean daily symptom score (SS) and medication score (MS) during the peak pollen season and the whole pollen season
The scores will be recorded daily during the pollen seasons of 2013 and 2014
Time frame: Up to 8 months
Skin reactivity to grass pollen extract by titrated skin prick testing
The titrated skin prick testing will be applied a total of 4 times before and after the pollen seasons of 2013 and 2014.
Time frame: Up to 15 months
Results of physical examination
Time frame: up to 22 months
Safety Laboratory: Blood biochemistry
Time frame: Up to 22 months
Safety laboratory: Urine analysis
Time frame: up to 22 months