Grass Pollen AllergyPhase 2NCT01445002
Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy
A Phase 2 study testing BM32 in people with Grass Pollen Allergy, run by Biomay AG at 1 site in Austria.
Trial summary
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. 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
- 79 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2011to Oct 2012
- 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
- History of seasonal allergic rhinitis from grass pollen
- Normal electrocardiogram
- Moderate to severe response to approx. 1500 grass pollen grains/m3 after 2 hrs of exposure in challenge chamber
- Positive skin prick test for grass pollen at or within 12 months preceding screening visit
- Positive RAST (class 2 or higher) for timothy grass pollen and to rPhl p 1 + rPhl p 5 at or within 12 months preceding screening visit
Who cannot join
- Pregnant or lactating females
- Females with childbearing potential not using medically acceptable birth control
- Structural nasal abnormalities, nasal polyposis, history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection
- Any respiratory disease other than mild asthma controlled with occasional short acting beta agonists and normal lung function
- Current or recent participation in another clinical trial
- SIT for grass pollen allergy in the last two years prior to study
Show all 14Show fewer
- Past or present disease, which may affect outcome of the trial, judged by investigator
- Autoimmune diseases, immune defects including immunosuppression, immune- complex immunopathies
- Suspected hypersensitivity to any ingredients of study medication
- Use of prohibited medication prior to screening and throughout study
- depot corticosteroids (12 weeks)
- oral corticosteroids (8 weeks)
- inhaled corticosteroids (4 weeks)
- Allergic symptoms at the time of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Dose Finding Study Based on the Effects of Three Subcutaneous Injections of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, on Responses to Allergen Challenge by Skin Testing and in the Vienna Challenge Chamber (VCC) as Well as Immunological Response in Subjects Know to Suffer From Grass-pollen Induced Allergic Rhinitis
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.
- Conditions
- Grass Pollen Allergy
- Being tested
- BM32, Placebo
- Keywords
- grass pollen allergy, immunotherapy, recombinant vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM32Biological
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
BM32Biological
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
BM32Biological
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
PlaceboBiological
Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections
| Study group | Role | What they receive |
|---|---|---|
| BM32 low dose | Experimental | 3 subcutaneous injections of 10 micrograms in a time span of 8 weeks Receives: Biological: BM32 |
| BM32 medium dose | Experimental | 3 subcutaneous injections of 20 micrograms in a time span of 8 weeks Receives: Biological: BM32 |
| BM32 high dose | Experimental | 3 subcutaneous injections of BM32 over a time span of 8 weeks Receives: Biological: BM32 |
| Placebo | Placebo comparator | 3 subcutaneous injections over a time span of 8 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 14 weeks
Secondary outcomes (12)
Minimum Effective dose for reduction of Total Non-Nasal Symptom Score (TNNSS) following inhalation challenge with grass pollen
Measured: Baseline and 14 weeks
Minimum effective dose for reduction of Global symptom Score upon inhalation challenge with grass pollen
Measured: Baseline and 4 weeks after final s.c. injection
Minimum effective dose for reduction of nasal airflow resistance after inhalation challenge with grass pollen
Measured: Baseline and 14 weeks
Minimum effective dose to reduce skin reaction to grass pollen allergen upon skin prick testing
Measured: Baseline and 14 weeks
Difference in FEV1 and FEV/FVC between screening and completion of vaccination
Measured: Baseline and 14 weeks
Frequency of local reactions to treatment
Measured: average of 8 weeks from 1st to last injection
Change in allergy specific total IgG
Measured: Baseline and average of 12 weeks after randomization
Change in allergy specific IgE
Measured: Baseline and average of 12 weeks after randomization
Frequency of systemic reactions to treatment
Measured: average of 8 weeks from 1st to last injection
Severity of local reactions to treatment
Measured: Average of 8 weeks from 1st to last injection
Severity of systemic reactions to treatment
Measured: Average of 8 weeks from 1st to last injection
Frequency of adverse events
Measured: average of 14 weeks from 1st injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomay AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445002
- Sponsor's protocol ID
- CS-BM32-002
- Other IDs
- 2011-003368-64
- Status last verified
- Jan 2013
- First submitted
- 26 Sep 2011
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Zieglmayer P, Focke-Tejkl M, Schmutz R, Lemell P, Zieglmayer R, Weber M, Kiss R, Blatt K, Valent P, Stolz F, Huber H, Neubauer A, Knoll A, Horak F, Henning R, Valenta R. Mechanisms, safety and efficacy of a B cell epitope-based vaccine for immunotherapy of grass pollen allergy. EBioMedicine. 2016 Sep;11:43-57. doi: 10.1016/j.ebiom.2016.08.022. Epub 2016 Aug 20.
PubMed 27650868
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Dose Finding Study Based on the Effects of Three Subcutaneous Injections of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, on Responses to Allergen Challenge by Skin Testing and in the Vienna Challenge Chamber (VCC) as Well as Immunological Response in Subjects Know to Suffer From Grass-pollen Induced Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01445002
- Acronym / sponsor ID
- CS-BM32-002
- Conditions
- Grass Pollen Allergy
- Keywords
- grass pollen allergy, immunotherapy, recombinant vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Biomay AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Oct 2011 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BM32 low dose | Experimental | Biological: BM323 subcutaneous injections of 10 micrograms in a time span of 8 weeks |
| BM32 medium dose | Experimental | Biological: BM323 subcutaneous injections of 20 micrograms in a time span of 8 weeks |
| BM32 high dose | Experimental | Biological: BM323 subcutaneous injections of BM32 over a time span of 8 weeks |
| Placebo | Placebo comparator | Biological: Placebo3 subcutaneous injections over a time span of 8 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- History of seasonal allergic rhinitis from grass pollen
- Normal electrocardiogram
- Moderate to severe response to approx. 1500 grass pollen grains/m3 after 2 hrs of exposure in challenge chamber
- Positive skin prick test for grass pollen at or within 12 months preceding screening visit
- Positive RAST (class 2 or higher) for timothy grass pollen and to rPhl p 1 + rPhl p 5 at or within 12 months preceding screening visit
Key exclusion criteria (14 listed)
- Pregnant or lactating females
- Females with childbearing potential not using medically acceptable birth control
- Structural nasal abnormalities, nasal polyposis, history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection
- Any respiratory disease other than mild asthma controlled with occasional short acting beta agonists and normal lung function
- Current or recent participation in another clinical trial
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 10 micrograms each of the BM32 components adsorbed on 0.3 mg of aluminum hydroxide every 4 week for a total of 3 injections | Biological | BM32 low dose |
| BM32Subcutaneous 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 | Biological | BM32 medium dose |
| BM32Subcutaneous 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 | Biological | BM32 high dose |
| PlaceboSubcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections | Biological | Placebo |
Primary outcome
Minimum effective dose for reduction of total nasal symptom score (TNSS) after inhalation challenge with grass pollen
Time frame: Baseline and 14 weeks
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.
12 secondary outcomes
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
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
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 14 Jan 2013.
- Derived from this study: PubMed 27650868Zieglmayer P, Focke-Tejkl M, Schmutz R, Lemell P, Zieglmayer R, Weber M, Kiss R, Blatt K, Valent P, Stolz F, Huber H, Neubauer A, Knoll A, Horak F, Henning R, Valenta R. Mechanisms, safety and efficacy of a B cell epitope-based vaccine for immunotherapy of grass pollen allergy. EBioMedicine. 2016 Sep;11:43-57. doi: 10.1016/j.ebiom.2016.08.022. Epub 2016 Aug 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: 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 1 site in Austria.
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 5 inclusion and 14 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 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Minimum effective dose for reduction of total nasal symptom score (TNSS) after inhalation challenge with grass pollen (time frame: Baseline and 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01445002, which also lists 1 linked publication.
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 14 Jan 2013.