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Avian flu vaccine achieves high immune response at low dosages

sanofi-pasteur releases data showing that its new investigational H5N1 pandemic influenza vaccine, which contains a proprietary adjuvant, achieved a high immune response at the lowest dose of H5N1 antigen reported to date

The vaccines arm of sanofi-aventis, sanofi-pasteur, has released data showing that its new investigational H5N1 pandemic influenza vaccine, which contains a proprietary adjuvant, achieved a high immune response at the lowest dose of H5N1 antigen reported to date.

The vaccine contained a mere 1.9 micrograms of antigen, but generated a high level of seroprotective immune response in over 70 per cent of clinical trial subjects, while a vaccine containing 3.75 micrograms of antigen generated a high level of sero-protective immune response in over 80 per cent of study participants.

Once fully developed, the vaccine should allow sanofi-pasteur to produce billions of
doses in a pandemic situation and greatly increase its ability to produce vaccines for stockpiling in advance of a pandemic.

Results are based on analysis of a clinical trial conducted in Belgium, involving 266 healthy adults aged between 18 to 40 years of age. The vaccine tested was produced from inactivated H5N1 virus and contains a new, proprietary adjuvant aimed at stimulating the immune system to increase the response to the vaccine.

Preliminary data also showed good cross-reactivity to a more recently circulating H5N1 strain. Further assessment of vaccine's ability to provide cross-protection to variants of the H5N1 strains is ongoing.

In order to increase its production capacity, the company initiated clinical trials with an adjuvant aimed at dramatically reducing the amount of antigen needed to elicit a protective immune response to the H5N1 strain currently identified by global health authorities and experts as a potential source for the next pandemic.

The avain flu vaccine was approved back in April 2007 and was the first to win FDA approval. The vaccine is already being stockpiled in the US in the event of an outbreak.

18th September 2007

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