Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy
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
2 other identifiers
interventional
79
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJanuary 14, 2013
January 1, 2013
5 months
September 26, 2011
January 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (12)
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
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
- +7 more secondary outcomes
Study Arms (4)
BM32 low dose
EXPERIMENTAL3 subcutaneous injections of 10 micrograms in a time span of 8 weeks
BM32 medium dose
EXPERIMENTAL3 subcutaneous injections of 20 micrograms in a time span of 8 weeks
BM32 high dose
EXPERIMENTAL3 subcutaneous injections of BM32 over a time span of 8 weeks
Placebo
PLACEBO COMPARATOR3 subcutaneous injections over a time span of 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biomay AGlead
Study Sites (1)
Allergy Center Vienna West
Vienna, Vienna, 1150, Austria
Related Publications (1)
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.
PMID: 27650868DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2011
First Posted
October 3, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2012
Study Completion
October 1, 2012
Last Updated
January 14, 2013
Record last verified: 2013-01