MedDataX Logo

Phase II Study of Grass Pollen Allergy Vaccine BM32

NCT ID: NCT01538979

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Grass Pollen Allergy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Grass pollen allergy Immunotherapy Recombinant vaccine Rhinitis, allergic, seasonal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BM32 low dose

7 subcutaneous injections of 20 micrograms over two grass pollen seasons

Group Type EXPERIMENTAL

BM32

Intervention Type BIOLOGICAL

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

BM32 high dose

7 subcutaneous injections of 40 micrograms over two grass pollen seasons

Group Type EXPERIMENTAL

BM32

Intervention Type BIOLOGICAL

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

7 subcutaneous injections over a time span of two pollen seasons

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biomay AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johannes Ring, Prof.

Role: STUDY_CHAIR

Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University

Vienna, Vienna, Austria

Site Status

Universitätsklinik für Dermatologie und Allergologie

Graz, , Austria

Site Status

Allergy Network Ghent University Hospital Ghent, Dept. Otorhiolaryngologie

Ghent, , Belgium

Site Status

Allergy Clinic Copenhagen University Hospital at Gentofte

Hellerup, , Denmark

Site Status

Department of Dermatology and Allergology Am Biederstein TU Munich

Munich, Bavaria, Germany

Site Status

Allergiezentrum Charite

Berlin, , Germany

Site Status

Klinik und Poliklnik für Dermatologie und Allergologie der Universität Bonn

Bonn, , Germany

Site Status

Dept. of Dermatology and Allergology University Medical Center Gieseen and Mrbaurg GmbH

Marburg, , Germany

Site Status

Zentrum für Rhinologie/Allergologie

Wiesbaden, , Germany

Site Status

Dept. of Internal Medicine Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, , Slovenia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Belgium Denmark Germany Netherlands Slovenia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-000442-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CS-BM32-003

Identifier Type: -

Identifier Source: org_study_id