The candidate H5N1 pandemic vaccine was produced using the company’s proprietary vero cell-based technology and is the first clinical evaluation of a vaccine using cell based technology.
Preliminary results from the phase I/II trial suggest that the vaccine is well tolerated in humans. Furthermore, the occurrence and severity of side effects are similar to what has been reported for seasonal influenza vaccines. In addition, the results suggest that the vaccine is highly immunogenic and elicits functional antibodies to H5N1 even at the lowest dose levels.
“These preliminary data, which must be confirmed in a larger study, suggest that the vaccine may provide wider protection for a larger number of people before and during a pandemic,” said Hartmut Ehrlich, vice president of Global R&D for Baxter BioScience.
In addition to this Baxter funded phase I/II clinical trial, the company is separately involved with the US government in other vero cell-based influenza vaccine development programs.
Cell-based systems for production of vaccines offer a number of potential benefits over more traditional egg-based systems. With cell-based technology there is no wait for the high growth or attenuated virus reassortants normally used when vaccine is produced in eggs.
The company plans to begin a phase III clinical trial of the candidate pandemic vaccine early next year and present final results by the end of 2007.