Phase II Study of Grass Pollen Allergy Vaccine BM32

Grass Pollen Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538979
• Other study ID #: CS-BM32-003
• Secondary ID: 2012-000442-35
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2012
• Last updated: December 17, 2015
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Biomay AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencyGermany: Paul-Ehrlich-InstitutNetherlands: Medicines Evaluation Board (MEB)Slovenia: Agency for Medicinal Products - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Grass Pollen Allergy
• Hypersensitivity
• Rhinitis, Allergic, Seasonal

Intervention

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
• 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
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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biomay AG

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Germany,  Netherlands,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Vital functions		Up to 22 months	Yes
Secondary	Safety laboratory hematology		up to 22 months	Yes
Secondary	Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season	The VAS will be recorded daily during the grass pollen seasons of 2013 and 2014	Up to 8 months	Yes
Secondary	Number of "bad days" during the peak pollen season and the whole pollen season	The number of bad days will be recorded daily during the grass pollen seasons of 2013 and 2014	Up to 8 months	No
Secondary	Number of symptom-free days during the peak pollen season and the whole pollen season	The mesure will be recorded daily during the grass pollen seasons of 2013 and 2014	Up to 8 months	No
Secondary	Rhinoconjunctivitis quality of life evaluation by RQLQ questionnaire during pollen season	The questionnaire will be completed on a weekly basis during the pollen seasons of 2013 and 2014.	Approx. 22 months	No
Secondary	Mean asthma score during pollen season	The score will be recorded on a daily basis duirng the pollen seasons of 2013 and 2014	Up to 8 months	No
Secondary	Mean allergy specific IgG and IgE antibodies before and after vaccination	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	No
Secondary	Mean daily symptom and medication score during the whole pollen season	The score will be recorded daily approximately during May 2013 - August 2013 and May 2014 - August 2014	Up to 8 months	No
Secondary	Mean daily symptom score (SS) and medication score (MS) during the peak pollen season and the whole pollen season	The scores will be recorded daily during the pollen seasons of 2013 and 2014	Up to 8 months	No
Secondary	Skin reactivity to grass pollen extract by titrated skin prick testing	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	No
Secondary	Results of physical examination		up to 22 months	Yes
Secondary	Safety Laboratory: Blood biochemistry		Up to 22 months	Yes
Secondary	Safety laboratory: Urine analysis		up to 22 months	Yes