Influenza Vaccine Development
In response to the need to develop improved influenza vaccines protective against both seasonal influenza and avian influenza strains with the potential for pandemic outbreaks, the Vaccine Research Center (VRC) has an ongoing program to develop novel vaccine approaches.
The VRC began clinical evaluation in December 2006 of an investigational H5 HA DNA vaccine that builds on the existing VRC DNA plasmid platform technology. The first study evaluated safety and immunogencity of H5 HA DNA given intramuscularly, and the second study evaluated intradermal delivery. A third clinical trial is scheduled to begin in November 2008 evaluating H5 HA DNA as a prime for inactivated H5N1 vaccine boost.
The FDA approved 2008-2009 seasonal influenza vaccine is unique in that all 3 strains of influenza virus represented in the vaccine are new and have not been included in previous seasonal influenza vaccines. It is known that the immune response to seasonal influenza vaccination is diminished in older people. In early 2009, the VRC plans to evaluate a seasonal influenza DNA vaccine that is antigen matched to the 2008-2009 FDA approved seasonal influenza vaccine in subjects ages 18-70 years. The investigational seasonal influenza DNA vaccine will be assessed as a potential prime for a traditional inactivated FDA-approved influenza vaccine boost. The use of DNA vaccine as a prime will potentially increase the frequency and magnitude of antibody and T cell responses in subjects as receiving a single dose of the FDA-approved seasonal influenza vaccine.
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