By Christopher P. Singer ---
In a March 29, 2007 press release Baxter International, Inc. announced that it will begin a Phase III clinical trial for an adjuvant-free vaccine against the H5N1 strain of influenza. The Phase III trial will be conducted in Europe in the first half of 2007, with results expected by the end of the year. Baxter is initiating this Phase III clinical trial in order to confirm the positive results from the Phase I and II trials. According to the press release the Phase I/II data indicates that the H5N1 candidate vaccine is highly immunogenic at low doses and provides cross immunity to divergent H5N1 strains.
According to Baxter, this vaccine is the first cell-based H5N1 pandemic vaccine to enter the clinic. The candidate vaccine is derived from the H5N1 strain A/Vietnam/1203/2004 and induces both cell- and antibody-mediated immune responses without the presence of an adjuvant. Baxter is producing the vaccine using its proprietary vero cell technology, which allows for faster production because it avoids production in eggs. More information about the vero cell manufacturing process, Phase III design, pre-pandemic efforts, and the Phase I/II results can be found at the above link.
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