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Tue 29 Aug 2006 04:00 AM

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Bird flu vaccine trial results 'encouraging'

The first vaccine against H5N1 bird flu, which requires only a very low dose of active ingredient, has proved effective in clinical tests, reports maker GlaxoSmithKline.

The first vaccine against H5N1 bird flu, which requires only a very low dose of active ingredient, has proved effective in clinical tests, reports maker GlaxoSmithKline.

The encouraging result means the pharma giant is on track to start producing commercial quantities of the vaccine by the end of this year.

The trial, announced by GlaxoSmithKline, found the vaccine provoked a human immune response at much smaller doses than previous versions.

To date, candidate vaccines have required high quantities of antigen, thus limiting their suitability for the mass market. However, of the 400 trial volunteers, all showed a good immune response from two 3.8 micrograms doses of antigen.

The advance could improve the world’s capacity to contain a human pandemic of the virus. However, it is only designed to protect against the current strain of H5N1 flu and might not be effective against a mutated version.

Jean-Pierre Garnier, chief executive of GSK, said the company was planning to seek regulatory approval for the vaccine in light of the success.

“These clinical trial results represent a significant breakthrough in the development of our pandemic flu vaccine,” he told reporters. “This is the first time such a low dose of H5N1 antigen has been able to stimulate this level of strong immune response.

“There is still a lot more to be done with this programme, but this validation of our approach provides us with the confidence to continue developing the vaccine, including assessment of its ability to offer cross-protection to variants of the H5N1 strain.

“All being well, we expect to make regulatory filings in the coming months.”

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