IMMUNOGENICITY AND SAFETY OF A SPLIT, INACTIVATED, TRIVALENT INFLUENZA VACCINE

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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. Background Routine yearly administration of flu vaccine is a long-standing recommendation and in 2004, the recommendation was extended to children 6 months to 2 years of ae. The vaccine may also be administered to anyone wishing to reduce the risk of contracting influenza. When widely used, influenza vaccines have repeatedly been shown to be highly effective at reducing influenza related morbidity and mortality. The extension of the influenza vaccine recommendation to include children has increased the number of influenza vaccine doses needed for production. As of last year, there were only 2 manufacturers of FDA licensed flu vaccine in the U.S. Vaccine supply was seriously compromised in 2004 when nearly 50% of the vaccine was lost due to safety concerns over vaccine production by 1 of the manufacturers. These events have led to a greater focus on finding ways to expand the number of available flu vaccine doses in the U.S. One possible way to increase the number of flu doses would be to administer smaller amounts of flu vaccine through the intradermal (ID) route (rather than the intramuscular [IM] route. Data from prior studies has shown that in healthy adults, as little as 3 ug of TIV (trivalent influenza vaccine) administered ID produced an immune response equivalent to a standard dose of TIV (15 ug per HA [hemaglutinin]) given IM. Purpose The purpose of this NIH-sponsored study is to find out if giving a smaller dose of flu vaccine through the intradermal route (just under the skin) will generate a comparable amount of antibodies (germ fighters) against flu as compared with the standard method of giving the flu vaccine through the intramuscular route. This study will also collect information about the relative safety of giving the vaccine through each of these routes. Methods The study will be conducted in healthy adults, 18 to 64 years of age. Each subject's participation will last approximately 21 days. After obtaining informed consent, participants will be randomized to one of 4 vaccine groups: 1) 6 ug of flu vaccine given intradermally with the Becton-Dickenson needle and syringe (BD ID system), 2) 9 ug of flu vaccine given intradermally with the BD ID System, 3) 3 ug of flu vaccine given ID using the Mantoux technique, and 4) 15 ug of flu vaccine given through the intramuscular route (control group). Each subject will receive a single dose of the flu vaccine. The first two groups who receive the vaccine intradermally using the BD ID system will receive an investigational formulation of the 2004-2005 trivalent flu vaccine. The second two groups will receive the licensed 2004-2005 trivalent flu vaccine, Fluzone, through the methods described above. The flu vaccines are provided by sanofi Pasteur. A blood sample will be obtained just prior to and approximately 21 days following administration of the flu vaccine. After the second blood sample is obtained, the participant will be offered the licensed formulation of the 2005-2006 flu vaccine (Fluzone; manufactured by sanofi Pasteur) using the standard intramuscular route.