Hypersensitivity Clinical Trial
Official title:
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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