Agency: Cordis | Branch: FP7 | Program: BSG-SME | Phase: SME-2012-1 | Award Amount: 1.81M | Year: 2012
Helicobacter pylori infection is highly prevalent worldwide and is an important cause of gastritis, peptic ulcer disease, and significantly gastric cancer. Because eradication requires treatment with multidrug regimens, there exists a very strong need for a vaccine to prevent initial infection. Immunization with H pylori protein subunits in humans has shown adjuvant-related adverse effects and only moderate effectiveness. However, with much greater knowledge of the molecular basis of infection and having learnt lessons from previous vaccine developments, the current consortium have drawn together three strand that are considered critical to the development of an effective vaccine: - Powerful, safe and multivalent antigens - Powerful, safe and multi-acting adjuvants - Powerful, modular and flexible oral vaccine delivery system All three of the above innovative technologies have been proven to be effective in doing what they are required to do, namely: - Antigens produce antibodies against a number of key H pylori bacterial components - Adjuvants stimulate the immune cells to produce significant numbers of long lasting antibodies - Delivery formulate antigens and adjuvants together and target the stomach and intestine This consortium (HELICOVAXOR) uniquely converges all three into a true vaccine with real potential to protect from H pylori infection. The vaccine is being designed for oral administration, efficacy, safety and temperature stability. This consortium has assembled leading academic, industrial and regulatory groups, the activities of which will be coordinated to perform analysis of the formulations, efficacy and safety testing of the vaccines and the preparation of a regulatory dossier, all required before the product can enter human clinical studies. If successful in pre-clinical studies, the consortium will work with vaccine companies to progress human studies and launch the product as a vaccine to confer protection from H pylori infection.