FLUZONE? IM INTRAMUSCULAR VACCINATION WITH FLUZONEIN HEALTHY ADULTS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Influenza causes acute respiratory illnesses in all age group, but is particularly debilitating in individuals with chronic diseases, in immunocompromised patients and in those at extreme of age. Vaccination against influenza virus is an important public health measure to help protect against morbidity and mortality associated with influenza, but during the 2004-2005 flu season, almost half of the US supply of influenza vaccine was lost due to a manufacturing problem. Therefore, methods that can expand the flu vaccine supply are desperately needed. Previous experience with animal and human studies showed that delivery of antigens via the intradermal (ID) route can initiate an efficient immune response. As compared to the intramuscular route (IM) of delivery, less antigen would be required to elicit similar levels of immune response. The current study is designed to evaluate the immunogenicity and safety of a trivalent inactivated influenza vaccine when administered via the ID route as compared to IM administration. This is a Phase II study involving up to 10 study sites and will enroll up to 1528 healthy adults of age 18-64. Stanford University Medical Center will enroll approximately 150 volunteers. Subjects will be randomized to receive one dose of trivalent inactivated influenza vaccine (TIV) by ID route [either 6 ¿g or 9 ¿g hemagglutinin (HA) of each strain administered by the Becton-Dickenson (BD) ID system or 3 ¿g of Fluzone¿ administered by the Mantoux technique]. These groups will be compared to individuals receiving a 15 ¿g (HA/strain) dose of Fluzone¿ by the standard IM route. The study vaccines will be of the 2004-2005 formulation. Blood samples for immunogenicity studies will be drawn prior to immunizatin and three weeks post-immunization for immunogenicity assays. Safety profile and subject acceptability of the TIV adminstered ID as compared to IM will also be evaluated. All subjects will be offered a dose of 2005-2006 Fluzone¿ IM following the completion of the study.