Skin Test Study of BM32

Biomay

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hypersensitivity

Treatments

Biological: BM32

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01350635

CS-BM32-001

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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