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

NCT ID: NCT01445002

Last Updated: 2013-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Grass Pollen Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BM32 low dose

3 subcutaneous injections of 10 micrograms in a time span of 8 weeks

Group Type: EXPERIMENTAL

BM32

Intervention Type: 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

BM32 medium dose

3 subcutaneous injections of 20 micrograms in a time span of 8 weeks

Group Type: EXPERIMENTAL

BM32

Intervention Type: 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

BM32 high dose

3 subcutaneous injections of BM32 over a time span of 8 weeks

Group Type: EXPERIMENTAL

BM32

Intervention Type: 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

Placebo

3 subcutaneous injections over a time span of 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomay AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Allergy Center Vienna West

Vienna, Vienna, Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 27650868 (View on PubMed)

Other Identifiers

2011-003368-64

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CS-BM32-002

Identifier Type: -

Identifier Source: org_study_id