Grass Pollen AllergyPhase 2NCT01538979
Phase II Study of Grass Pollen Allergy Vaccine BM32
A Phase 2 study testing BM32 in people with Grass Pollen Allergy, run by Biomay AG at 11 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Grass Pollen Allergy
- What is being tested?
- BM32
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Mar 2012to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
Germany5 sites
Allergiezentrum Charite
Berlin, 10117
Klinik und Poliklnik für Dermatologie und Allergologie der Universität Bonn
Bonn, 53105
Dept. of Dermatology and Allergology University Medical Center Gieseen and Mrbaurg GmbH
Marburg, 35043
Department of Dermatology and Allergology Am Biederstein TU Munich
Munich, Bavaria, 80802
Zentrum für Rhinologie/Allergologie
Wiesbaden, 65183
Austria2 sites
Universitätsklinik für Dermatologie und Allergologie
Graz, 8036
Medical University
Vienna, State of Vienna, 1090
Belgium1 site
Allergy Network Ghent University Hospital Ghent, Dept. Otorhiolaryngologie
Ghent, 9000
Denmark1 site
Allergy Clinic Copenhagen University Hospital at Gentofte
Hellerup
Netherlands1 site
Dept. of Internal Medicine Erasmus Medical Center
Rotterdam, 3105
Slovenia1 site
University Clinic of Respiratory and Allergic Diseases Golnik
Golnik, 4204
About this study
Official title: Phase IIb Study on the Safety and Efficacy of BM32, a Recombinant Hypoallergenic Vaccine for Immunotherapy of Grass Pollen Allergy
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.
Read the 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.
- Conditions
- Grass Pollen Allergy
- Being tested
- BM32, Placebo
- Keywords
- Grass pollen allergy, Immunotherapy, Recombinant vaccine, Rhinitis, allergic, seasonal
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM32Biological
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
BM32Biological
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
PlaceboBiological
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
| Study group | Role | What they receive |
|---|---|---|
| BM32 low dose | Experimental | 7 subcutaneous injections of 20 micrograms over two grass pollen seasons Receives: Biological: BM32 |
| BM32 high dose | Experimental | 7 subcutaneous injections of 40 micrograms over two grass pollen seasons Receives: Biological: BM32 |
| Placebo | Placebo comparator | 7 subcutaneous injections over a time span of two pollen seasons Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 3 months
Secondary outcomes (14)
Vital functions
Measured: Up to 22 months
Safety laboratory hematology
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 15 months
Results of physical examination
Measured: up to 22 months
Safety Laboratory: Blood biochemistry
Measured: Up to 22 months
Safety laboratory: Urine analysis
Measured: up to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grass Pollen AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomay AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Ring, Prof., Study chair, Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538979
- Sponsor's protocol ID
- CS-BM32-003
- Other IDs
- 2012-000442-35
- Status last verified
- Dec 2015
- First submitted
- 7 Feb 2012
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Study on the Safety and Efficacy of BM32, a Recombinant Hypoallergenic Vaccine for Immunotherapy of Grass Pollen Allergy
- ClinicalTrials.gov ID
- NCT01538979
- Acronym / sponsor ID
- CS-BM32-003
- Conditions
- Grass Pollen Allergy
- Keywords
- Grass pollen allergy, Immunotherapy, Recombinant vaccine, Rhinitis, allergic, seasonal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Biomay AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BM32 low dose | Experimental | Biological: BM327 subcutaneous injections of 20 micrograms over two grass pollen seasons |
| BM32 high dose | Experimental | Biological: BM327 subcutaneous injections of 40 micrograms over two grass pollen seasons |
| Placebo | Placebo comparator | Biological: Placebo7 subcutaneous injections over a time span of two pollen seasons |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BM32Subcutaneous 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 | Biological | BM32 low dose |
| BM32Subcutaneous 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 | Biological | BM32 high dose |
| PlaceboSubcutaneous 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 | Biological | Placebo |
Primary outcome
Mean daily combined symptom medication score (SMS)during the peak of the pollen season.
Time frame: Up to 3 months
The score will be recorded daily for the 30-45 days with the highest pollen count in each center
14 secondary outcomes
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
Time frame: Up to 8 months
Number of "bad days" during the peak pollen season and the whole pollen season
Time frame: Up to 8 months
Number of symptom-free days during the peak pollen season and the whole pollen season
Time frame: Up to 8 months
Rhinoconjunctivitis quality of life evaluation by RQLQ questionnaire during pollen season
Time frame: Approx. 22 months
Mean asthma score during pollen season
Time frame: Up to 8 months
Mean allergy specific IgG and IgE antibodies before and after vaccination
Time frame: Up to 16 months
Mean daily symptom and medication score during the whole pollen season
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
Time frame: Up to 8 months
Skin reactivity to grass pollen extract by titrated skin prick testing
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Ring, Prof. study chair
Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BM32 in people with Grass Pollen Allergy, run by Biomay AG at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Austria, Belgium, Denmark, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily combined symptom medication score (SMS)during the peak of the pollen season. (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.