Clinical trial NCT01538979: Phase II Study of Grass Pollen Allergy Vaccine BM32
Official title: Phase IIb Study on the Safety and Efficacy of BM32, a Recombinant Hypoallergenic Vaccine for Immunotherapy of Grass Pollen Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Grass Pollen Allergy
Keywords: Grass pollen allergy
Immunotherapy
Recombinant vaccine
Rhinitis, allergic, seasonal
Lead sponsor: Biomay AG
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Mean daily combined symptom medication score (SMS)during the peak of the pollen season.
timeFrame: Up to 3 months
Secondary outcomes:
measure: Vital functions
timeFrame: Up to 22 months
measure: Safety laboratory hematology
timeFrame: up to 22 months
measure: Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season
timeFrame: Up to 8 months
measure: Number of "bad days" during the peak pollen season and the whole pollen season
timeFrame: Up to 8 months
measure: Number of symptom-free days during the peak pollen season and the whole pollen season
timeFrame: Up to 8 months
measure: Rhinoconjunctivitis quality of life evaluation by RQLQ questionnaire during pollen season
timeFrame: Approx. 22 months
measure: Mean asthma score during pollen season
timeFrame: Up to 8 months
measure: Mean allergy specific IgG and IgE antibodies before and after vaccination
timeFrame: Up to 16 months
measure: Mean daily symptom and medication score during the whole pollen season
timeFrame: Up to 8 months
measure: Mean daily symptom score (SS) and medication score (MS) during the peak pollen season and the whole pollen season
timeFrame: Up to 8 months
measure: Skin reactivity to grass pollen extract by titrated skin prick testing
timeFrame: Up to 15 months
measure: Results of physical examination
timeFrame: up to 22 months
measure: Safety Laboratory: Blood biochemistry
timeFrame: Up to 22 months
measure: Safety laboratory: Urine analysis
timeFrame: up to 22 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinik für Dermatologie und Allergologie
city: Vienna
country: Austria
facility: Medical University
city: Ghent
country: Belgium
facility: Allergy Network Ghent University Hospital Ghent, Dept. Otorhiolaryngologie
city: Hellerup
country: Denmark
facility: Allergy Clinic Copenhagen University Hospital at Gentofte
city: Munich
country: Germany
facility: Department of Dermatology and Allergology Am Biederstein TU Munich
state: Bavaria
city: Berlin
country: Germany
facility: Allergiezentrum Charite
city: Bonn
country: Germany
facility: Klinik und Poliklnik für Dermatologie und Allergologie der Universität Bonn
city: Marburg
country: Germany
facility: Dept. of Dermatology and Allergology University Medical Center Gieseen and Mrbaurg GmbH
city: Wiesbaden
country: Germany
facility: Zentrum für Rhinologie/Allergologie
city: Rotterdam
country: Netherlands
facility: Dept. of Internal Medicine Erasmus Medical Center
city: Golnik
country: Slovenia
facility: University Clinic of Respiratory and Allergic Diseases Golnik
Study officials:
affiliation: Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie
name: Johannes Ring, Prof.
role: STUDY_CHAIR
References: