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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003368-64 | EudraCT Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BM32 low dose | Experimental | 3 subcutaneous injections of 10 micrograms in a time span of 8 weeks |
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| BM32 medium dose | Experimental | 3 subcutaneous injections of 20 micrograms in a time span of 8 weeks |
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| BM32 high dose | Experimental | 3 subcutaneous injections of BM32 over a time span of 8 weeks |
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| Placebo | Placebo Comparator | 3 subcutaneous injections over a time span of 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BM32 | Biological | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Effective dose for reduction of Total Non-Nasal Symptom Score (TNNSS) following inhalation challenge with grass pollen | Baseline and 14 weeks | |
| Minimum effective dose for reduction of Global symptom Score upon inhalation challenge with grass pollen |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy Center Vienna West | Vienna | State of Vienna | 1150 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27650868 | Derived | 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. |
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| BM32 | Biological | 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 |
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| BM32 | Biological | 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 |
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| Placebo | Biological | Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections |
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| Baseline and 4 weeks after final s.c. injection |
| Minimum effective dose for reduction of nasal airflow resistance after inhalation challenge with grass pollen | Baseline and 14 weeks |
| Minimum effective dose to reduce skin reaction to grass pollen allergen upon skin prick testing | Baseline and 14 weeks |
| Difference in FEV1 and FEV/FVC between screening and completion of vaccination | Baseline and 14 weeks |
| Frequency of local reactions to treatment | average of 8 weeks from 1st to last injection |
| Change in allergy specific total IgG | Baseline and average of 12 weeks after randomization |
| Change in allergy specific IgE | Baseline and average of 12 weeks after randomization |
| Frequency of systemic reactions to treatment | average of 8 weeks from 1st to last injection |
| Severity of local reactions to treatment | Average of 8 weeks from 1st to last injection |
| Severity of systemic reactions to treatment | Average of 8 weeks from 1st to last injection |
| Frequency of adverse events | average of 14 weeks from 1st injection |