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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomay AG
ClinicalTrials.gov Identifier:
NCT01445002
First received: September 26, 2011
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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.

Condition Intervention Phase
Grass Pollen Allergy
Biological: BM32
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biomay AG:

Primary Outcome Measures:
  • Minimum effective dose for reduction of total nasal symptom score (TNSS) after inhalation challenge with grass pollen [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Minimum Effective dose for reduction of Total Non-Nasal Symptom Score (TNNSS) following inhalation challenge with grass pollen [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Minimum effective dose for reduction of nasal airflow resistance after inhalation challenge with grass pollen [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
  • Minimum effective dose to reduce skin reaction to grass pollen allergen upon skin prick testing [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
  • Difference in FEV1 and FEV/FVC between screening and completion of vaccination [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
  • Frequency of local reactions to treatment [ Time Frame: average of 8 weeks from 1st to last injection ] [ Designated as safety issue: Yes ]
  • Change in allergy specific total IgG [ Time Frame: Baseline and average of 12 weeks after randomization ] [ Designated as safety issue: No ]
  • Change in allergy specific IgE [ Time Frame: Baseline and average of 12 weeks after randomization ] [ Designated as safety issue: No ]
  • Frequency of systemic reactions to treatment [ Time Frame: average of 8 weeks from 1st to last injection ] [ Designated as safety issue: Yes ]
  • Severity of local reactions to treatment [ Time Frame: Average of 8 weeks from 1st to last injection ] [ Designated as safety issue: Yes ]
  • Severity of systemic reactions to treatment [ Time Frame: Average of 8 weeks from 1st to last injection ] [ Designated as safety issue: Yes ]
  • Frequency of adverse events [ Time Frame: average of 14 weeks from 1st injection ] [ Designated as safety issue: Yes ]

Enrollment: 79
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BM32 low dose
3 subcutaneous injections of 10 micrograms in a time span of 8 weeks
Biological: BM32
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
Experimental: BM32 medium dose
3 subcutaneous injections of 20 micrograms in a time span of 8 weeks
Biological: BM32
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
Experimental: BM32 high dose
3 subcutaneous injections of BM32 over a time span of 8 weeks
Biological: BM32
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
Placebo Comparator: Placebo
3 subcutaneous injections over a time span of 8 weeks
Biological: Placebo
Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445002

Locations
Austria
Allergy Center Vienna West
Vienna, Austria, 1150
Sponsors and Collaborators
Biomay AG
  More Information

No publications provided

Responsible Party: Biomay AG
ClinicalTrials.gov Identifier: NCT01445002     History of Changes
Other Study ID Numbers: CS-BM32-002, 2011-003368-64
Study First Received: September 26, 2011
Last Updated: January 10, 2013
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Biomay AG:
grass pollen allergy
immunotherapy
recombinant vaccine

Additional relevant MeSH terms:
Hypersensitivity
Rhinitis, Allergic, Seasonal
Immune System Diseases
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 31, 2014