SANOFI PASTEUR MAKES FIRST TRIAL LOT OF H7N1 VACCINE

Sanofi pasteur, the vaccines arm of French drugmaker sanofi-aventis, has within the framework of a collaborative research project funded by the European Commission, FLUPAN, generated the first clinical trial lot of a new generation of H7N1 pandemic vaccine. This trial will broaden the company's pandemic preparedness program initiated with the development of H5N1 vaccines.

Two influenza subtypes, H5 and H7, have recently caused highly pathogenic avian influenza. While most vaccine development has focused on H5N1 strains, avian H7-containing viruses remain a significant threat and have caused infections in humans in Europe during the last three years.

This trial will be the first to assess the safety and the ability to generate an immune response of a split, inactivated prototype H7N1 vaccine produced in cells. Healthy adults will be vaccinated with one of four formulations: two dosages (12 and 24 micrograms), with or without an aluminum hydroxide adjuvant, which is commonly used to increase the immune response to vaccines.

Sanofi pasteur produced the H7N1 vaccine using the PER.C6 cell-based technology from its partner Crucell. The company selected PER.C6 cells for their high susceptibility to influenza viruses, making the production of large amounts of influenza vaccine feasible for both pandemic and seasonal strains. The company entered into a strategic and exclusive agreement with Crucell in 2003 to further develop, manufacture and market cell-based influenza vaccine products.