CompletedNCT01445002Updated Jan 14, 2013

Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy

A Phase 2 interventional study of BM32 and BM32 in Grass Pollen Allergy, sponsored by Biomay AG. Completed at 1 site in Austria. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-01-14.

Sponsored by Biomay AG · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 79
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Grass Pollen Allergy

Browse trials for

Keywords

grass pollen allergy
immunotherapy
recombinant vaccine

In context

Rhinitis, Allergic, Seasonal

392 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 25 are open to participants now.

This study's enrollment of 79 is below the median of 136 across 356 interventional studies indexed under Rhinitis, Allergic, Seasonal.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

Biomay AG is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 79 participants (actual)

Study arms

Experimental
BM32 low dose
3 subcutaneous injections of 10 micrograms in a time span of 8 weeks
Biological: BM32
Experimental
BM32 medium dose
3 subcutaneous injections of 20 micrograms in a time span of 8 weeks
Biological: BM32
Experimental
BM32 high dose
3 subcutaneous injections of BM32 over a time span of 8 weeks
Biological: BM32
Placebo comparator
Placebo
3 subcutaneous injections over a time span of 8 weeks
Biological: Placebo

Interventions

BiologicalBM32
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
BiologicalBM32
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
BiologicalBM32
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
BiologicalPlacebo
Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections

What researchers measure

Primary outcomes

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.
Time frame: Baseline and 14 weeks

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

Study locations

1 site

Allergy Center Vienna West
Vienna, 1150, Austria

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01445002
Lead sponsor: Biomay AG
Responsible party: Sponsor
First posted: Oct 3, 2011
Start date: Oct 2011
Primary completion: Mar 2012
Completion: Oct 2012
Last update: Jan 14, 2013

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rhinitis, Allergic, Seasonal→

Other studies from this sponsor

Biomay AG

Start the discussion