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Apr 1
Baxter’s Adjuvant-free H5N1 Flu Vaccine Passed Final Phase I/II Clinical Trial, Continuing to Phase III
Baxter International Inc. (NYSE: BAX) has recently announced the successful results of its final Phase I/II clinical trial for its adjuvant-free investigational pandemic H5N1 influenza vaccine.

Baxter's candidate H5N1 vaccine is derived from H5N1 strain A/Vietnam/1203/2004. Its antigen composition and structure closely resembles the actual pathogen circulating in nature.

The candidate vaccine induces an immune response (both cell and antibody mediated) that is similar to the body's defense against a natural virus, without the need to incorporate additional agents (adjuvants) to enhance immune response.

baxter.gifClinical data revealed that Baxter's H5N1 candidate vaccine is highly immunogenic at low doses, and induces substantial levels of cross immunity against widely divergent H5N1 strains.

According to John Oxford, professor of Virology, The Queen Mary School of Medicine, London, United Kingdom:

"The results of the Phase I/II clinical trial suggested that this candidate vaccine may provide protection against divergent strains of virus, even at low dose levels without an adjuvant.

The Phase III clinical trial is designed to confirm these findings and provide a solid measure of the vaccine's potential to protect a large number of people before and during a possible pandemic."

Vaccinations of the vaccine for the phase III trial will commence middle of this year, data is expected to be available by the end of 2007.

Find more details from the press release.


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