SNY » Topics » Vienna, Austria - October 18, 2006

This excerpt taken from the SNY 6-K filed Oct 19, 2006.
Vienna, Austria – October 18, 2006 – Sanofi pasteur, the vaccines business of the sanofi-aventis Group, today announced that its H5N1 pre-pandemic vaccine induces antibodies that neutralize additional H5N1 circulating virus not included in the original vaccine formulation. These data, presented at the 2nd International Conference on Influenza Vaccines for the World held in Vienna, Austria, further demonstrate the value of sanofi pasteur candidate vaccine for pandemic preparedness.

“These encouraging data show the potential for a pre-pandemic vaccine to offer broad protection by inducing antibodies that neutralize H5N1 from more recent circulating viruses. Improving the repertoire of antibody response is an important goal for pandemic influenza vaccines” said Maria Zambon, MD, Deputy Director Virus Reference Division, Health Protection Agency, London, who conducted the laboratory tests.

Analysis of blood samples from volunteers who participated in the first phase I clinical trial conducted in 2005 with H5N1 pre-pandemic vaccine from sanofi pasteur showed the potential of the vaccine to protect against recent H5N1 circulating viruses.

Vaccinated volunteers developed serum antibodies that were able to neutralize diverse H5N1 viruses (A/turkey/Turkey/1/2005 wt (wild-type) and rg (reverse-genetic) clade 2, and A/Vietnam/1194/2004 wt and rg clade 1). The tested vaccine contains the A/Vietnam/1194/2004 rg strain. These more recently circulating H5N1 viruses have caused human infections in several European countries in 2005 and 2006, and continue to cause infections in parts of South East Asia.


Vice-President Communications sanofi pasteur: Alain BERNAL – U. S. Media Relations: Len LAVENDA
Tél. : +33 (0)4 37 37 01 00 - Fax : +33 (0)4 37 37 77 37 - Sanofi Pasteur S.A. : Siège mondial : 2, avenue Pont Pasteur - F-69367 Lyon cedex 07 -
Tel.: +1 570 839 7187 - Fax: +1 570 839 0955 - Sanofi Pasteur Inc. - Discovery Drive - Swiftwater, PA 18370 -0187 - USA -

Among volunteers who developed antibodies to the vaccine, cross-neutralization results were similar in those who received high antigen (30µg) and those who received lower antigen (7.5µg) vaccine doses. Results were also similar in volunteers who received alum-adjuvanted and non-adjuvanted vaccine (alum is an additive commonly used to increase the immune response to vaccines). The ability to provide cross-protection against diverse influenza strains with less antigen is an important feature for any pandemic or pre-pandemic vaccine, as it will allow for production of more doses to protect the largest number of people in the case of a pandemic.

These new data reinforce conclusions of the sanofi pasteur phase I study published in May 2006 [1] which demonstrated multiple dosage formulations of the H5N1 pre-pandemic vaccine candidate generates an immune response with and without an adjuvant.

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