Back to resultsPhase II Study of Grass Pollen Allergy Vaccine BM32
Primary Purpose
Grass Pollen Allergy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BM32
BM32
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Grass Pollen Allergy focused on measuring Grass pollen allergy, Immunotherapy, Recombinant vaccine, Rhinitis, allergic, seasonal
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Universitätsklinik für Dermatologie und Allergologie
- Medical University
- Allergy Network Ghent University Hospital Ghent, Dept. Otorhiolaryngologie
- Allergy Clinic Copenhagen University Hospital at Gentofte
- Department of Dermatology and Allergology Am Biederstein TU Munich
- Allergiezentrum Charite
- Klinik und Poliklnik für Dermatologie und Allergologie der Universität Bonn
- Dept. of Dermatology and Allergology University Medical Center Gieseen and Mrbaurg GmbH
- Zentrum für Rhinologie/Allergologie
- Dept. of Internal Medicine Erasmus Medical Center
- University Clinic of Respiratory and Allergic Diseases Golnik
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
BM32 low dose
BM32 high dose
Placebo
Arm Description
7 subcutaneous injections of 20 micrograms over two grass pollen seasons
7 subcutaneous injections of 40 micrograms over two grass pollen seasons
7 subcutaneous injections over a time span of two pollen seasons
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Vital functions
Safety laboratory hematology
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
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
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
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.
Mean asthma score during pollen season
The score will be recorded on a daily basis duirng the pollen seasons of 2013 and 2014
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)
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
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
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.
Results of physical examination
Safety Laboratory: Blood biochemistry
Safety laboratory: Urine analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01538979
Brief Title
Phase II Study of Grass Pollen Allergy Vaccine BM32
Official Title
Phase IIb Study on the Safety and Efficacy of BM32, a Recombinant Hypoallergenic Vaccine for Immunotherapy of Grass Pollen Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biomay AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grass Pollen Allergy
Keywords
Grass pollen allergy, Immunotherapy, Recombinant vaccine, Rhinitis, allergic, seasonal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BM32 low dose
Arm Type
Experimental
Arm Description
7 subcutaneous injections of 20 micrograms over two grass pollen seasons
Arm Title
BM32 high dose
Arm Type
Experimental
Arm Description
7 subcutaneous injections of 40 micrograms over two grass pollen seasons
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
7 subcutaneous injections over a time span of two pollen seasons
Intervention Type
Biological
Intervention Name(s)
BM32
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
BM32
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean daily combined symptom medication score (SMS)during the peak of the pollen season.
Description
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
Secondary Outcome Measure Information:
Title
Vital functions
Time Frame
Up to 22 months
Title
Safety laboratory hematology
Time Frame
up to 22 months
Title
Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season
Description
The VAS will be recorded daily during the grass pollen seasons of 2013 and 2014
Time Frame
Up to 8 months
Title
Number of "bad days" during the peak pollen season and the whole pollen season
Description
The number of bad days will be recorded daily during the grass pollen seasons of 2013 and 2014
Time Frame
Up to 8 months
Title
Number of symptom-free days during the peak pollen season and the whole pollen season
Description
The mesure will be recorded daily during the grass pollen seasons of 2013 and 2014
Time Frame
Up to 8 months
Title
Rhinoconjunctivitis quality of life evaluation by RQLQ questionnaire during pollen season
Description
The questionnaire will be completed on a weekly basis during the pollen seasons of 2013 and 2014.
Time Frame
Approx. 22 months
Title
Mean asthma score during pollen season
Description
The score will be recorded on a daily basis duirng the pollen seasons of 2013 and 2014
Time Frame
Up to 8 months
Title
Mean allergy specific IgG and IgE antibodies before and after vaccination
Description
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
Title
Mean daily symptom and medication score during the whole pollen season
Description
The score will be recorded daily approximately during May 2013 - August 2013 and May 2014 - August 2014
Time Frame
Up to 8 months
Title
Mean daily symptom score (SS) and medication score (MS) during the peak pollen season and the whole pollen season
Description
The scores will be recorded daily during the pollen seasons of 2013 and 2014
Time Frame
Up to 8 months
Title
Skin reactivity to grass pollen extract by titrated skin prick testing
Description
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
Title
Results of physical examination
Time Frame
up to 22 months
Title
Safety Laboratory: Blood biochemistry
Time Frame
Up to 22 months
Title
Safety laboratory: Urine analysis
Time Frame
up to 22 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Ring, Prof.
Organizational Affiliation
Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie
Official's Role
Study Chair
Facility Information:
Facility Name
Universitätsklinik für Dermatologie und Allergologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medical University
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Allergy Network Ghent University Hospital Ghent, Dept. Otorhiolaryngologie
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Allergy Clinic Copenhagen University Hospital at Gentofte
City
Hellerup
Country
Denmark
Facility Name
Department of Dermatology and Allergology Am Biederstein TU Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80802
Country
Germany
Facility Name
Allergiezentrum Charite
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinik und Poliklnik für Dermatologie und Allergologie der Universität Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Dept. of Dermatology and Allergology University Medical Center Gieseen and Mrbaurg GmbH
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Zentrum für Rhinologie/Allergologie
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
Facility Name
Dept. of Internal Medicine Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3105
Country
Netherlands
Facility Name
University Clinic of Respiratory and Allergic Diseases Golnik
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
12. IPD Sharing Statement
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Phase II Study of Grass Pollen Allergy Vaccine BM32
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