NCT01350635

Skin Test Study of BM32

Evaluation of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, by Skin Testing

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Biomay AG · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to grass pollen allergic patients

Detailed description

BM32 is a hypoallergenic grass pollen allergy vaccine which consists of an aluminum hydroxide-adsorbed equimolar mix of four active ingredients, BM321, BM322, BM325 and BM326. The four active ingredients are purified recombinant proteins containing non-allergenic peptides from the four major timothy grass pollen allergens, Phl p 1 (BM321), Phl p 2 (BM322), Phl p 5 (BM325) and Phl p 6 (BM326) which are fused to the PreS domain of hepatitis B virus, a protein used in childhood vaccines. BM32 holds promise not to induce IgE mediated immediate type (e.g. anaphylactic reactions) or T-cell mediated late phase side effects during immunotherapy. The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins due to their low/absent IgE- and T cell-reactivity exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to grass pollen allergic patients (n=60). This study will therefore provide important information for immunotherapy studies based on BM32.

Conditions

• Hypersensitivity

Interventions

Type	Name	Description
BIOLOGICAL	BM32	BM32 will be applied in sterile phosphate buffer solution. Drug will be applied in concentrations of 11,33 and 100 micrograms/ml

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-07-01
• Completion: 2011-09-01
• First posted: 2011-05-10
• Last updated: 2015-12-18

Locations

1 site across 1 country: Austria