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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
181

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biomay AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings