sanofi pasteur, the vaccines business of the sanofi-aventis Group, initiated its first clinical study, with a new generation of seasonal influenza vaccine produced using the PER.C6 cell culture technology of Dutch biotechnology company Crucell N V. This trial represents one of sanofi pasteur's initiatives to diversify flu vaccine manufacturing technologies.

The trial conducted in the US is part of a contract awarded by the US Department of Health and Human Services (HHS) to accelerate the development of a new cell culture-based influenza vaccine.

"This trial will assess the safety and ability to generate an immune response of a cell culture-based vaccine that could provide an important alternative to traditional flu vaccines," said Dennis Morrison, MD, Clinical Investigator at the first trial site, Bio-Kinetic Clinical Applications, Inc. in Springfield, Missouri. The clinical study is the first step toward sanofi pasteur filing a biologics license application for a cell culture-based trivalent split inactivated seasonal influenza vaccine with the Food and Drug Administration (FDA).

The phase I clinical trial will be conducted on 100 healthy adults, 18-64 years of age. Half of the study participants will receive the cell-based vaccine and the other half a traditional egg-based control vaccine. "We are pleased to participate in a study to evaluate the viability of the next generation of influenza vaccines," said Cynthia Strout, MD, Clinical Investigator at the second trial site, and the Coastal Carolina Research Centre in Mt. Pleasant, South Carolina.

This vaccine was developed using PER.C6 cell culture technology, licensed from Crucell. Cell culture technology could allow sanofi pasteur to reduce dependence on eggs while offering an additional reliable production technology.

The production scale potential of the PER.C6 cell line has been demonstrated in a successful bioreactor run of 20,000 liters. This project breaks new ground in vaccines technology by demonstrating effective large-scale production capacity using cell culture on a commercial scale. This scale-up process was achieved under a subcontracting agreement between sanofi pasteur and Lonza Biologics plc.

As the world leader in the research, development and manufacture of influenza vaccine, sanofi pasteur is actively involved in other projects in the US and Europe with the goal of developing new influenza vaccines.

Crucell's PER.C6 technology is a cell line developed for the large-scale manufacture of biological products including vaccines. PER.C6 cells are highly susceptible to influenza viruses, thereby making the production of large amounts of influenza vaccine feasible. Currently used influenza vaccines are produced using embryonated chicken eggs and there is value to improving the timely production of new vaccines in large quantities to combat a potential future influenza pandemic. A PER.C6-based vaccine offers the possibility of advantages for both epidemics.