Phase II Study of Grass Pollen Allergy Vaccine BM32

NCT01538979 | Completed Phase 2 DMC

• 2 other identifiers: CS-BM32-0032012-000442-35
• Study Type: interventional
• Target: 181
• Locations: 6 countries
• Sites: 11

Brief Summary

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.

Conditions

Grass Pollen Allergy

Keywords

Grass pollen allergy; Immunotherapy; Recombinant vaccine; Rhinitis, allergic, seasonal

Outcome Measures

Primary Outcomes (1)

• Mean daily combined symptom medication score (SMS)during the peak of the pollen season.

  The score will be recorded daily for the 30-45 days with the highest pollen count in each center

  Up to 3 months

Secondary Outcomes (14)

• Vital functions

  Up to 22 months

• Safety laboratory hematology

  up to 22 months

• Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season

  Up to 8 months

• Number of "bad days" during the peak pollen season and the whole pollen season

  Up to 8 months

• Number of symptom-free days during the peak pollen season and the whole pollen season

  Up to 8 months

Study Arms (3)

BM32 low dose

EXPERIMENTAL

7 subcutaneous injections of 20 micrograms over two grass pollen seasons

Biological: BM32

BM32 high dose

EXPERIMENTAL

7 subcutaneous injections of 40 micrograms over two grass pollen seasons

Biological: BM32

Placebo

PLACEBO COMPARATOR

7 subcutaneous injections over a time span of two pollen seasons

Biological: Placebo

Interventions

BM32 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 low dose

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biomay AG: lead

Study Sites (11)

Medical University

Vienna, Vienna, 1090, Austria

Location

Universitätsklinik für Dermatologie und Allergologie

Graz, 8036, Austria

Location

Allergy Network Ghent University Hospital Ghent, Dept. Otorhiolaryngologie

Ghent, 9000, Belgium

Location

Allergy Clinic Copenhagen University Hospital at Gentofte

Hellerup, Denmark

Location

Department of Dermatology and Allergology Am Biederstein TU Munich

Munich, Bavaria, 80802, Germany

Location

Allergiezentrum Charite

Berlin, 10117, Germany

Location

Klinik und Poliklnik für Dermatologie und Allergologie der Universität Bonn

Bonn, 53105, Germany

Location

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

Marburg, 35043, Germany

Location

Zentrum für Rhinologie/Allergologie

Wiesbaden, 65183, Germany

Location

Dept. of Internal Medicine Erasmus Medical Center

Rotterdam, 3105, Netherlands

Location

University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, 4204, Slovenia

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Johannes Ring, Prof.

  Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 27, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

DE (5); AU (2); SL (1); DK (1); NL (1); BE (1)