Sanofi Pasteur Announces Preliminary Trial Results for a First H5N1 Pre-Pandemic Influenza Vaccine Candidate With an Adjuvant

LYON, France -- Sanofi pasteur, the vaccines business of the sanofi-aventis Group, announced that preliminary results of clinical trials fielded in France of an adjuvanted candidate H5N1 pre-pandemic influenza vaccine demonstrated a good immune response in a significant number of volunteers. This is the first trial of an H5N1pre-pandemic influenza vaccine candidate that compared vaccines with and without adjuvants. Preliminary results showed that the vaccine is safe and well-tolerated in 300 healthy volunteers. A 30 microgram-dose with an adjuvant in a two-dose regimen demonstrated an immune response at levels consistent with requirements of regulatory agencies for licensure of seasonal influenza vaccine.

Sanofi pasteur characterized the preliminary results as a sign of progress and providing direction for further development of a pandemic influenza vaccine. The company also noted that immune responses were detected in a number of volunteers receiving lower doses. Subsequent trials will explore different dosages, which may be helpful in answering questions about dose-sparing strategies and which is being widely discussed among the public health community.

The trial was sponsored by sanofi pasteur and fielded in three sites in France: Necker and Cochin Hospitals in Paris, and Garches Hospital, with professor Jean-Louis Bresson as the principal investigator.

The vaccine used the reference strain provided by the UK's National Institute for Biological Standards and Control (NIBSC). Assays were performed at NIBSC and the UK Health Protection Agency.

As definitive results become available, they will be presented and published, as well as submitted to appropriate regulatory authorities for review.

The data will be submitted as part of the company's core "mock up" vaccine dossier to the European Agency for the Evaluation of Medicinal Products (EMEA). The core dossier has been developed in strict accordance to the EMEA guidelines. This process is expected to reduce the time necessary for approval of a pandemic vaccine in Europe once a strain is identified and a pandemic is declared. Follow-up studies, currently being planned, will be performed using vaccine produced at large scale, which will mimic the manufacturing scale that will be used during a declared pandemic.

This is one of a number of initiatives by the company to help prepare the world for the possibility of an influenza pandemic.

- Sanofi pasteur is investing in a major expansion of its influenza vaccine production capacity in the US, and also of its vaccine production capacity in France (Val de Reuil facility).

- Sanofi pasteur has entered into an agreement with the French Ministry

of Health to produce pre-pandemic vaccine in 2005 to create a1.4 million dose

stockpile with the H5N1 candidate studied in this trial. By this agreement,

the company could also provide enough vaccine to protect up to 28 million

people in the event of a pandemic being declared, once the actual virus

strain responsible is identified.

- Sanofi pasteur has entered into a series of contracts with the U.S. government to increase that country's pandemic preparedness efforts. The contracts include investigational doses for clinical trials; bulk vaccine for stockpiles; establishment and maintenance of laying flocks to enable year-round egg production (not just seasonal), as well as a contract to speed the production process for new cell culture influenza vaccines, including the design of a US-based cell-culture vaccine manufacturing facility.

- A contract has also been signed with the Australian government for the supply of vaccine in the event of a pandemic influenza outbreak. There are also contacts concerning pandemic preparedness between sanofi pasteur and other governments in Europe and worldwide

- In addition, sanofi pasteur is the only vaccine manufacturer to participate in FLUPAN, an EU-funded collaboration. FLUPAN partners include the National Institute for Biological Standards & Control (NIBSC -UK), the University of Reading (UK), Istituto Superiore di Sanita, (Italy), the Health Protection Agency (UK), and the University of Bergen (Norway). FLUPAN is intended to improve the level of pandemic preparedness in the EU. Sanofi pasteur is to produce a vaccine to combat another strain with pandemic potential (H7N1) that will be used in a FLUPAN clinical study.

Source: Sanofi pasteur