Clinical trial NCT01445002: Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Grass Pollen Allergy
Keywords: grass pollen allergy
immunotherapy
recombinant vaccine
Lead sponsor: Biomay AG
Sponsor class: INDUSTRY
First posted: 2011-10-03
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Minimum effective dose for reduction of total nasal symptom score (TNSS) after inhalation challenge with grass pollen
timeFrame: Baseline and 14 weeks
Secondary outcomes:
measure: Minimum Effective dose for reduction of Total Non-Nasal Symptom Score (TNNSS) following inhalation challenge with grass pollen
timeFrame: Baseline and 14 weeks
measure: Minimum effective dose for reduction of Global symptom Score upon inhalation challenge with grass pollen
timeFrame: Baseline and 4 weeks after final s.c. injection
measure: Minimum effective dose for reduction of nasal airflow resistance after inhalation challenge with grass pollen
timeFrame: Baseline and 14 weeks
measure: Minimum effective dose to reduce skin reaction to grass pollen allergen upon skin prick testing
timeFrame: Baseline and 14 weeks
measure: Difference in FEV1 and FEV/FVC between screening and completion of vaccination
timeFrame: Baseline and 14 weeks
measure: Frequency of local reactions to treatment
timeFrame: average of 8 weeks from 1st to last injection
measure: Change in allergy specific total IgG
timeFrame: Baseline and average of 12 weeks after randomization
measure: Change in allergy specific IgE
timeFrame: Baseline and average of 12 weeks after randomization
measure: Frequency of systemic reactions to treatment
timeFrame: average of 8 weeks from 1st to last injection
measure: Severity of local reactions to treatment
timeFrame: Average of 8 weeks from 1st to last injection
measure: Severity of systemic reactions to treatment
timeFrame: Average of 8 weeks from 1st to last injection
measure: Frequency of adverse events
timeFrame: average of 14 weeks from 1st injection
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allergy Center Vienna West
Study officials:
References:
citation: 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.