Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy

Grass Pollen Allergy Clinical Trial

Official title:

Safety and Dose Finding Study Based on the Effects of Three Subcutaneous Injections of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, on Responses to Allergen Challenge by Skin Testing and in the Vienna Challenge Chamber (VCC) as Well as Immunological Response in Subjects Know to Suffer From Grass-pollen Induced Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445002
• Other study ID #: CS-BM32-002
• Secondary ID: 2011-003368-64
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2011
• Last updated: January 10, 2013
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: Biomay AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the dose response of immunotherapy against grass pollen allergy using the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by:

• skin prick testing

• grass pollen inhalation challenge

• antibody responses. In addition, the safety of subcutaneous application of BM32 will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• History of seasonal allergic rhinitis from grass pollen

• Normal electrocardiogram

• Moderate to severe response to approx. 1500 grass pollen grains/m3 after 2 hrs of exposure in challenge chamber

• Positive skin prick test for grass pollen at or within 12 months preceding screening visit

• Positive RAST (class 2 or higher) for timothy grass pollen and to rPhl p 1 + rPhl p 5 at or within 12 months preceding screening visit

Exclusion Criteria:

• Pregnant or lactating females

• Females with childbearing potential not using medically acceptable birth control

• Structural nasal abnormalities, nasal polyposis, history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection

• Any respiratory disease other than mild asthma controlled with occasional short acting beta agonists and normal lung function

• Current or recent participation in another clinical trial

• SIT for grass pollen allergy in the last two years prior to study

• Past or present disease, which may affect outcome of the trial, judged by investigator

• Autoimmune diseases, immune defects including immunosuppression, immune- complex immunopathies

• Suspected hypersensitivity to any ingredients of study medication

• Use of prohibited medication prior to screening and throughout study

• depot corticosteroids (12 weeks)

• oral corticosteroids (8 weeks)

• inhaled corticosteroids (4 weeks)

• Allergic symptoms at the time of screening

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 10 micrograms each of the BM32 components adsorbed on 0.3 mg of aluminum hydroxide every 4 week for a total of 3 injections
• BM32
Subcutaneous injection of 20 micrograms of each of the BM32 components adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections
• BM32
Subcutaneous injection of 40 micrograms of each of the BM32 components adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks until a total of 3 injections
• Placebo
Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections

Locations

Country	Name	City	State
Austria	Allergy Center Vienna West	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Biomay AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum effective dose for reduction of total nasal symptom score (TNSS) after inhalation challenge with grass pollen	Difference in the total Nasal Symptom Score (TNSS) between spending 6 hrs in the Vienna Challenge Chamber (VCC) at screening and spending 6 hrs in the VCC four weeks after the last subcutaneous injection of BM32.	Baseline and 14 weeks	No
Secondary	Minimum Effective dose for reduction of Total Non-Nasal Symptom Score (TNNSS) following inhalation challenge with grass pollen		Baseline and 14 weeks	No
Secondary	Minimum effective dose for reduction of Global symptom Score upon inhalation challenge with grass pollen		Baseline and 4 weeks after final s.c. injection	No
Secondary	Minimum effective dose for reduction of nasal airflow resistance after inhalation challenge with grass pollen		Baseline and 14 weeks	No
Secondary	Minimum effective dose to reduce skin reaction to grass pollen allergen upon skin prick testing		Baseline and 14 weeks	No
Secondary	Difference in FEV1 and FEV/FVC between screening and completion of vaccination		Baseline and 14 weeks	No
Secondary	Frequency of local reactions to treatment		average of 8 weeks from 1st to last injection	Yes
Secondary	Change in allergy specific total IgG		Baseline and average of 12 weeks after randomization	No
Secondary	Change in allergy specific IgE		Baseline and average of 12 weeks after randomization	No
Secondary	Frequency of systemic reactions to treatment		average of 8 weeks from 1st to last injection	Yes
Secondary	Severity of local reactions to treatment		Average of 8 weeks from 1st to last injection	Yes
Secondary	Severity of systemic reactions to treatment		Average of 8 weeks from 1st to last injection	Yes
Secondary	Frequency of adverse events		average of 14 weeks from 1st injection	Yes