Phase II Study of Grass Pollen Allergy Vaccine BM32
- Conditions
- Grass Pollen Allergy
- Interventions
- Biological: BM32Biological: Placebo
- Registration Number
- NCT01538979
- Lead Sponsor
- Biomay AG
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
- Positive history of grass pollen allergy
- Positive skin prick test reaction to grass pollen extract
- Grass pollen specific IgE and rPhl p 1/rPhl p 5 specific IgE (>3 kUA/L)
- Moderate to severe symptoms of grass pollen allergy during pollen peak
-
Symptomatic perennial allergies
-
Atopic dermatitis
-
Pregnancy or breast feeding
-
Women with childbearing potential not using medically accepted birth control
-
Autoimmune diseases, immune defects, immune suppression
-
Immune complex induced immunopathies
-
Contra indications for adrenaline
-
Severe general maladies, malignancies
-
Patients on long-term systematic corticosteroids, immune suppressive drugs, tranquilizers or psychoactive drugs
-
Contra indication for skin prick testing
-
Bronchial asthma not controlled by low dose inhaled corticosteroids
-
Chronic use of beta blockers
-
Participation in another clinical trial within one month prior to study
-
Participation in SIT trial in 2 years prio to study
-
Patients who had a previous grass pollen SIT
-
Risk of non-compliance with study procedures
-
Use of prohibited medications
- Depot corticosteroids - 12 weeks prior to enrolment
- Oral corticosteroids - 8 weeks prior to enrolment
- High dose inhaled corticosteroids - 4 weeks prior to enrolment
- Use of H1 antihistamines 3 days prior to enrolment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BM32 high dose BM32 7 subcutaneous injections of 40 micrograms over two grass pollen seasons Placebo Placebo 7 subcutaneous injections over a time span of two pollen seasons BM32 low dose BM32 7 subcutaneous injections of 20 micrograms over two grass pollen seasons
- Primary Outcome Measures
Name Time Method Mean daily combined symptom medication score (SMS)during the peak of the pollen season. Up to 3 months The score will be recorded daily for the 30-45 days with the highest pollen count in each center
- Secondary Outcome Measures
Name Time Method Mean daily symptom score (SS) and medication score (MS) during the peak pollen season and the whole pollen season Up to 8 months The scores will be recorded daily during the pollen seasons of 2013 and 2014
Safety Laboratory: Blood biochemistry Up to 22 months Number of symptom-free days during the peak pollen season and the whole pollen season Up to 8 months The mesure will be recorded daily during the grass pollen seasons of 2013 and 2014
Rhinoconjunctivitis quality of life evaluation by RQLQ questionnaire during pollen season Approx. 22 months The questionnaire will be completed on a weekly basis during the pollen seasons of 2013 and 2014.
Results of physical examination up to 22 months Vital functions Up to 22 months Mean daily symptom and medication score during the whole pollen season Up to 8 months The score will be recorded daily approximately during May 2013 - August 2013 and May 2014 - August 2014
Safety laboratory hematology up to 22 months Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season Up to 8 months The VAS will be recorded daily during the grass pollen seasons of 2013 and 2014
Mean allergy specific IgG and IgE antibodies before and after vaccination Up to 16 months These antibody levels will be recorded a total of five times (01/2013, 04/2013, 09/2013, 01/2014 and 04/2014)
Number of "bad days" during the peak pollen season and the whole pollen season Up to 8 months The number of bad days will be recorded daily during the grass pollen seasons of 2013 and 2014
Mean asthma score during pollen season Up to 8 months The score will be recorded on a daily basis duirng the pollen seasons of 2013 and 2014
Skin reactivity to grass pollen extract by titrated skin prick testing Up to 15 months The titrated skin prick testing will be applied a total of 4 times before and after the pollen seasons of 2013 and 2014.
Safety laboratory: Urine analysis up to 22 months
Trial Locations
- Locations (11)
Department of Dermatology and Allergology Am Biederstein TU Munich
🇩🇪Munich, Bavaria, Germany
Medical University
🇦🇹Vienna, Austria
Allergy Network Ghent University Hospital Ghent, Dept. Otorhiolaryngologie
🇧🇪Ghent, Belgium
Zentrum für Rhinologie/Allergologie
🇩🇪Wiesbaden, Germany
Allergy Clinic Copenhagen University Hospital at Gentofte
🇩🇰Hellerup, Denmark
University Clinic of Respiratory and Allergic Diseases Golnik
🇸🇮Golnik, Slovenia
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
Dept. of Internal Medicine Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Universitätsklinik für Dermatologie und Allergologie
🇦🇹Graz, Austria