A total of 450 healthy adults will be enrolled at sites in the US. The clinical sites are part of the National Institute of Allergy and Infectious Diseases (NIAID)-sponsored vaccine and treatment evaluation units (VTEU).
Sanofi Pasteur, part of Sanofi-Aventis, has 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.
The phase I trial will test the vaccine’s safety and ability to generate an immune response in 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.
“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,” said NIAID director Dr Anthony Fauci.
In addition to the previous contract awarded to Sanofi Pasteur, in May 2004 NIAID also awarded a contract to Chiron Corporation to produce H5N1 vaccine for clinical trials.