Skin Test Study of BM32

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

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

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.

Inclusion Criteria:

• Positive history of grass pollen allergy and positive skin prick test reaction to grass pollen extract
• Age between 18 and 60 years
• Subjects must have a standard health care insurance
• Subject must appear capable to understand and comply with all relevant aspects of the study protocol

Exclusion Criteria:

• pregnancy or breast feeding
• autoimmune diseases, immune defects including immuno- suppression, immune-complex-induced immunopathies
• contra-indication for adrenaline
• severe general maladies, malignant diseases
• patients under long-term treatment with systemic corticosteroids, immunosuppressive drugs, tranquilizers or psychoactive drugs
• contra-indications for skin prick testing such as: skin inflammation in the test area, urticaria facticia, unstable or uncontrolled bronchial asthma (30)
• use of beta-blockers
• participation in another clinical trial within one month prior to the study; however, participation during the previous month solely in the form of blood donation without other interventions will be acceptable
• risk of non-compliance with the study procedure and restrictions
• use of oral H1 antihistamines within the previous 3 days, oral Ketotifen within the previous 5 days and topical corticosteroids in the test area within the previous 14 days.
• systemic (short-term) corticosteroids within the previous 14 days