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A clinical trial reported yesterday by GlaxoSmithKline has found that the vaccine provokes a human immune response at much smaller doses than previous versions.
Previous candidate vaccines have worked only with very high quantities of antigen — the active ingredient that triggers an immune response — limiting their suitability for the mass market.
Jean-Pierre Garnier, chief executive of GSK, said the company was planning to seek regulatory approval for the vaccine after the success of the trial. It involved 400 healthy adults in Belgium, more than 80 per cent of whom showed a good immune response from two doses of just 3.8 micrograms of antigen. Production of hundreds of millions of doses for government stockpiles could begin next year. The vaccine, however, is designed to protect only against the strain of H5N1 flu that is circulating at present, and might not be effective against a mutated version.
Dr Garnier said: “These clinical trial results represent a significant breakthrough in the development of our pandemic flu vaccine. 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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