Sites in Rochester, NY, 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," says NIAID Director Anthony S. Fauci, M.D.
"NIAID has supported research on H5N1, the strain responsible for this deadly form of avian influenza, since 1997 when the first cases in humans were reported. The initiation of this vaccine trial marks a key advance in our efforts to prepare to respond to an avian flu pandemic," adds Dr. Fauci.
Sanofi pasteur, Swiftwater, PA, 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.
H5N1 avian influenza leads to severe disease in both birds and humans. Between January 2004 and March 11, 2005, there were 69 confirmed cases of and 46 deaths from H5N1 infection in humans reported to the World Health Organization. To date, there has been a small number of cases where human-to-human transmission of the virus may have occurred. However, public health experts fear that the virus may evolve into one that is more easily transmitted between people. If this were to happen, a worldwide pandemic could follow.
Influenza pandemics are global outbreaks that emerge infrequently and unpredictably and involve strains of virus to which humans have little or no immunity. H5N1 is one such flu virus strain. The last influenza pandemic swept the globe in 1968; many public health officials believe the world is overdue for another one.
The VTEUs now enrolling adult volunteers are
In addition to the previous contract awarded to sanofi pasteur, in May 2004 NIAID also awarded a contract to Chiron Corporation of Emeryville, CA, to produce H5N1 vaccine for clinical trials.
NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.
NIAID's Web site on influenza research: http://www.
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News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.