Phase II Study of Grass Pollen Allergy Vaccine BM32

December 17, 2015 updated by: Biomay AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Experimental: BM32 high dose
7 subcutaneous injections of 40 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean daily combined symptom medication score (SMS)during the peak of the pollen season.
Time Frame: Up to 3 months
The score will be recorded daily for the 30-45 days with the highest pollen count in each center
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital functions
Time Frame: Up to 22 months
Up to 22 months
Safety laboratory hematology
Time Frame: up to 22 months
up to 22 months
Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season
Time Frame: Up to 8 months
The VAS will be recorded daily during the grass pollen seasons of 2013 and 2014
Up to 8 months
Number of "bad days" during the peak pollen season and the whole pollen season
Time Frame: Up to 8 months
The number of bad days will be recorded daily during the grass pollen seasons of 2013 and 2014
Up to 8 months
Number of symptom-free days during the peak pollen season and the whole pollen season
Time Frame: Up to 8 months
The mesure will be recorded daily during the grass pollen seasons of 2013 and 2014
Up to 8 months
Rhinoconjunctivitis quality of life evaluation by RQLQ questionnaire during pollen season
Time Frame: Approx. 22 months
The questionnaire will be completed on a weekly basis during the pollen seasons of 2013 and 2014.
Approx. 22 months
Mean asthma score during pollen season
Time Frame: Up to 8 months
The score will be recorded on a daily basis duirng the pollen seasons of 2013 and 2014
Up to 8 months
Mean allergy specific IgG and IgE antibodies before and after vaccination
Time Frame: Up to 16 months
These antibody levels will be recorded a total of five times (01/2013, 04/2013, 09/2013, 01/2014 and 04/2014)
Up to 16 months
Mean daily symptom and medication score during the whole pollen season
Time Frame: Up to 8 months
The score will be recorded daily approximately during May 2013 - August 2013 and May 2014 - August 2014
Up to 8 months
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
The scores will be recorded daily during the pollen seasons of 2013 and 2014
Up to 8 months
Skin reactivity to grass pollen extract by titrated skin prick testing
Time Frame: Up to 15 months
The titrated skin prick testing will be applied a total of 4 times before and after the pollen seasons of 2013 and 2014.
Up to 15 months
Results of physical examination
Time Frame: up to 22 months
up to 22 months
Safety Laboratory: Blood biochemistry
Time Frame: Up to 22 months
Up to 22 months
Safety laboratory: Urine analysis
Time Frame: up to 22 months
up to 22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomay AG

Investigators

  • Study Chair: Johannes Ring, Prof., Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-BM32-003
  • 2012-000442-35 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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