Intercell starts TD vaccine efficacy trial
Vienna – Austrian firm Intercell AG has initiated a phase II efficacy trial as part of its clinical development program for the investigational travellers’ diarrhoea (TD) vaccine in India. The primary objective of the field trial is the prevention of all moderate/ severe diarrhoeal casesin which LT, LT/ST or ST toxins (ETEC) are detected. The trial will enrol about 800 travellers from the UK and Germany. The TD vaccine system is a combination of a patch containing the dry-formulated LT (heat-labile toxin from E. coli, the vaccine antigen) with a skin preparation system (SPS). The skin preparation system disrupts the upper layer of the skin and prepares it for the antigen delivery. The antigen is dissolved from the patch and diffuses into the skin by transepidermal water loss. Activated Langerhans cells take the vaccine antigen to the draining lymph nodes, where the immune response is initiated. The project is currently in the crucial phase III testing stages in about 1,800 European travellers to Latin America. Intercell expects the first results for early 2011 at the latest (more...).