US Medical Agency Initiates Trial of Experimental Avian Flu Vaccine

Fast-track recruitment has begun for a trial to investigate the safety of a vaccine against H5N1 avian influenza, according to the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Sites in Rochester, N.Y., Baltimore and Los Angeles will enroll a total of 450 healthy adults. The clinical sites are part of the NIAID-sponsored Vaccine and Treatment Evaluation Units (VTEU).

"While there have been relatively few cases worldwide of H5N1 avian influenza infection in humans, the public health community is concerned that the virus will develop the capability of efficiently spreading from human to human and thus create a risk for a worldwide pandemic," said NIAID Director Anthony Fauci.

Sanofi-pasteur manufactured the trial vaccine, which is an inactivated vaccine made from an H5N1 virus isolated in Southeast Asia in 2004. Sanofi-pasteur, formerly Aventis Pasteur, was awarded a contract by NIAID to manufacture the H5N1 vaccine in May 2004.

This Phase I trial will test the vaccine's safety and ability to generate an immune response in 450 healthy adults aged 18 to 64. If the vaccine is shown to be safe in adults, there are plans to test it in other populations, such as the elderly and children.