NCT01445002

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Biomay AG · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Grass Pollen Allergy

Interventions

Type	Name	Description
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
BIOLOGICAL	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
BIOLOGICAL	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
BIOLOGICAL	Placebo	Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-03-01
• Completion: 2012-10-01
• First posted: 2011-10-03
• Last updated: 2013-01-14

Locations

1 site across 1 country: Austria