Phase II Study of Grass Pollen Allergy Vaccine BM32

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomay AG
ClinicalTrials.gov Identifier:
NCT01538979
First received: February 7, 2012
Last updated: December 17, 2015
Last verified: December 2015
  Purpose
The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off allergy symptoms over a two year study period.

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: Phase IIb Study on the Safety and Efficacy of BM32, a Recombinant Hypoallergenic Vaccine for Immunotherapy of Grass Pollen Allergy

Resource links provided by NLM:


Further study details as provided by Biomay AG:

Primary Outcome Measures:
  • Mean daily combined symptom medication score (SMS)during the peak of the pollen season. [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    The score will be recorded daily for the 30-45 days with the highest pollen count in each center


Secondary Outcome Measures:
  • Vital functions [ Time Frame: Up to 22 months ] [ Designated as safety issue: Yes ]
  • Safety laboratory hematology [ Time Frame: up to 22 months ] [ Designated as safety issue: Yes ]
  • Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: Yes ]
    The VAS will be recorded daily during the grass pollen seasons of 2013 and 2014

  • Number of "bad days" during the peak pollen season and the whole pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
    The number of bad days will be recorded daily during the grass pollen seasons of 2013 and 2014

  • Number of symptom-free days during the peak pollen season and the whole pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
    The mesure will be recorded daily during the grass pollen seasons of 2013 and 2014

  • Rhinoconjunctivitis quality of life evaluation by RQLQ questionnaire during pollen season [ Time Frame: Approx. 22 months ] [ Designated as safety issue: No ]
    The questionnaire will be completed on a weekly basis during the pollen seasons of 2013 and 2014.

  • Mean asthma score during pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
    The score will be recorded on a daily basis duirng the pollen seasons of 2013 and 2014

  • Mean allergy specific IgG and IgE antibodies before and after vaccination [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]
    These antibody levels will be recorded a total of five times (01/2013, 04/2013, 09/2013, 01/2014 and 04/2014)

  • Mean daily symptom and medication score during the whole pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
    The score will be recorded daily approximately during May 2013 - August 2013 and May 2014 - August 2014

  • Mean daily symptom score (SS) and medication score (MS) during the peak pollen season and the whole pollen season [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
    The scores will be recorded daily during the pollen seasons of 2013 and 2014

  • Skin reactivity to grass pollen extract by titrated skin prick testing [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]
    The titrated skin prick testing will be applied a total of 4 times before and after the pollen seasons of 2013 and 2014.

  • Results of physical examination [ Time Frame: up to 22 months ] [ Designated as safety issue: Yes ]
  • Safety Laboratory: Blood biochemistry [ Time Frame: Up to 22 months ] [ Designated as safety issue: Yes ]
  • Safety laboratory: Urine analysis [ Time Frame: up to 22 months ] [ Designated as safety issue: Yes ]

Enrollment: 181
Study Start Date: March 2012
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BM32 low dose
7 subcutaneous injections of 20 micrograms over two grass pollen seasons
Biological: BM32
Subcutaneous injection of 20 micrograms of each of the protein components of BM32 adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season
Experimental: BM32 high dose
7 subcutaneous injections of 40 micrograms over two grass pollen seasons
Biological: BM32
Subcutaneous injection of 40 micrograms of each of the protein components of BM32 adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season
Placebo Comparator: Placebo
7 subcutaneous injections over a time span of two pollen seasons
Biological: Placebo
Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every four weeks before each pollen season and one injection after pollen season for a total of 7 injections

Detailed Description:
The present study is designed to evaluate the efficacy and safety of a treatment with the recombinant vaccine BM32 during two consecutive grass pollen seasons. Efficacy evaluation will be performed on the basis of allergy symptoms and use of relief medication as well as based on immunological parameters. After patient assessment during a screening season, patients will be randomized to one of two doses of BM32 or placebo. Patients will receive three injections of BM32 pre-season and one post-season boost injection to maintain optimal allergen specific IgG responses. Outcome will be measured after both seasons individually.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive history of grass pollen allergy
  • Positive skin prick test reaction to grass pollen extract
  • Grass pollen specific IgE and rPhl p 1/rPhl p 5 specific IgE (>3 kUA/L)
  • Moderate to severe symptoms of grass pollen allergy during pollen peak

Exclusion Criteria:

  • Symptomatic perennial allergies
  • Atopic dermatitis
  • Pregnancy or breast feeding
  • Women with childbearing potential not using medically accepted birth control
  • Autoimmune diseases, immune defects, immune suppression
  • Immune complex induced immunopathies
  • Contra indications for adrenaline
  • Severe general maladies, malignancies
  • Patients on long-term systematic corticosteroids, immune suppressive drugs, tranquilizers or psychoactive drugs
  • Contra indication for skin prick testing
  • Bronchial asthma not controlled by low dose inhaled corticosteroids
  • Chronic use of beta blockers
  • Participation in another clinical trial within one month prior to study
  • Participation in SIT trial in 2 years prio to study
  • Patients who had a previous grass pollen SIT
  • Risk of non-compliance with study procedures
  • Use of prohibited medications

    • Depot corticosteroids - 12 weeks prior to enrolment
    • Oral corticosteroids - 8 weeks prior to enrolment
    • High dose inhaled corticosteroids - 4 weeks prior to enrolment
    • Use of H1 antihistamines 3 days prior to enrolment
  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: NCT01538979

Locations
Austria
Universitätsklinik für Dermatologie und Allergologie
Graz, Austria, 8036
Medical University
Vienna, Austria, 1090
Belgium
Allergy Network Ghent University Hospital Ghent, Dept. Otorhiolaryngologie
Ghent, Belgium, 9000
Denmark
Allergy Clinic Copenhagen University Hospital at Gentofte
Hellerup, Denmark
Germany
Department of Dermatology and Allergology Am Biederstein TU Munich
Munich, Bavaria, Germany, 80802
Allergiezentrum Charite
Berlin, Germany, 10117
Klinik und Poliklnik für Dermatologie und Allergologie der Universität Bonn
Bonn, Germany, 53105
Dept. of Dermatology and Allergology University Medical Center Gieseen and Mrbaurg GmbH
Marburg, Germany, 35043
Zentrum für Rhinologie/Allergologie
Wiesbaden, Germany, 65183
Netherlands
Dept. of Internal Medicine Erasmus Medical Center
Rotterdam, Netherlands, 3105
Slovenia
University Clinic of Respiratory and Allergic Diseases Golnik
Golnik, Slovenia, 4204
Sponsors and Collaborators
Biomay AG
Investigators
Study Chair: Johannes Ring, Prof. Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie
  More Information

No publications provided

Responsible Party: Biomay AG
ClinicalTrials.gov Identifier: NCT01538979     History of Changes
Other Study ID Numbers: CS-BM32-003  2012-000442-35 
Study First Received: February 7, 2012
Last Updated: December 17, 2015
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Germany: Paul-Ehrlich-Institut
Netherlands: Medicines Evaluation Board (MEB)
Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by Biomay AG:
Grass pollen allergy
Immunotherapy
Recombinant vaccine
Rhinitis, allergic, seasonal

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

ClinicalTrials.gov processed this record on February 11, 2016