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Home » BAXTER ANNOUNCES RESULTS FROM PANDEMIC FLU VACCINE STUDY
BAXTER ANNOUNCES RESULTS FROM PANDEMIC FLU VACCINE STUDY
October 4, 2006
Baxter International has announced results from a preliminary evaluation of its Phase I/II clinical trial of whole-virus H5N1 influenza candidate vaccine. The results represent the first clinical evaluation of a vero cell-based candidate H5N1 pandemic vaccine.
The candidate H5N1 pandemic vaccine was produced using the company's proprietary vero cell-based technology platform and inactivated wild-type H5N1 strain A/Vietnam/1203/2004. The clinical trial was conducted in 270 healthy adults in Austria and Singapore using four different antigen concentrations ranging from 3.75 to 30 micrograms. The 7.5- and 15-microgram antigen concentrations were tested with and without adjuvant, a substance added to vaccines to improve immune response.
Preliminary results from this trial suggest that the vaccine is well-tolerated in humans: the occurrence and severity of side effects at all dose levels are similar to what has been reported for licensed interpandemic (or seasonal) influenza vaccines. Most common side effects are injection site reactions, headaches and fatigue.
In addition, the preliminary results suggest that the vaccine is highly immunogenic and elicits functional antibodies to H5N1 even at the lowest dose level of 3.75 micrograms. Preliminary analysis of serum samples obtained from the study subjects suggests both the neutralization of the pandemic virus contained in the vaccine and cross-neutralization against widely diverse strains of H5N1, including both HongKong/156/97 and Indonesia/05/05.
Baxter 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.
KEYWORDS Drug Pipeline Alert
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