Sanofi pasteur's adjuvanted avian flu vaccine efficacious, study says

By Angela McDaniels

Seattle, Dec. 15 - Sanofi pasteur said preliminary results from clinical trials of an adjuvanted H5N1 pre-pandemic influenza vaccine candidate demonstrated a good immune response in a significant number of volunteers.

A 30 mcg-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, the company said. Immune responses were also detected in a number of volunteers receiving lower doses.

Preliminary results showed that the vaccine was safe and well-tolerated in 300 healthy volunteers.

This is the first trial of an H5N1 pre-pandemic influenza vaccine candidate to compare vaccines with and without adjuvants, the company said.

Subsequent trials will explore different dosages, which may be helpful in answering questions about dose-sparing strategies being widely discussed among the public health community, the company said.

The trial was fielded in three sites in France: Necker Hospital, Cochin Hosptial and Garches Hospital, with Jean-Louis Bresson as the principal investigator. The vaccine used the reference strain provided by the U.K.'s National Institute for Biological Standards and Control.

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. 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, the company said.

This is one of a number of initiatives by Sanofi pasteur to help prepare for a possible influenza pandemic:

• The company is investing in a major expansion of its influenza vaccine production capacity in the United States and its vaccine production capacity in France.

• Sanofi pasteur has entered into an agreement with the French Ministry of Health to produce pre-pandemic vaccine in 2005 to create a 1.4 million dose stockpile with the H5N1 candidate studied in this trial.

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 the 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 and a contract to speed the production process for new cell culture influenza vaccines.

• 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, a European Union-funded collaboration intended to improve the level of pandemic preparedness. Sanofi pasteur is to produce a vaccine to combat another strain with pandemic potential (H7N1) that will be used in a FluPan clinical study.

According to the World Health Organization, the next flu pandemic is likely to result in 1 million to 2.3 million hospitalizations and 280,000 to 650,000 deaths in industrialized nations alone, the company said.

Sanofi pasteur, based in Lyon, France, is the vaccines business of the Sanofi-aventis Group, a pharmaceutical company based in Paris.

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