VRC 309: A Multi-Center, Open-Label, Randomized Phase I Study of an Investigational Influenza DNA Vaccine Followed by 2009/2010 Seasonal Influenza Trivalent Inactivated Vaccine (TIV) Compared to Two Injections of TIV in Adults 45-70 Years

Detailed Summary

Background: * Vaccines are substances used to try to create resistance or immunity to a disease and to prevent an infection. Investigators are looking into improved ways to give and test the results of different kinds of vaccines. * Researchers are interested in comparing the results of an experimental DNA vaccine for the prevention of seasonal influenza against a standard FDA-approved vaccine for the prevention of seasonal influenza. The experimental DNA vaccine is not yet approved by the FDA for preventing the flu. Objectives: \- To test the safety and immune response of an experimental DNA vaccine for seasonal influenza, compared to the standard vaccine for seasonal influenza. Eligibility: \- Healthy individuals between ages 45 and 70 who have not yet received the seasonal influenza vaccine. Design: * Participants will have six planned clinic visits (Weeks 0, 1, 3, 4, 6, and 27) and two telephone follow-up contacts (within 2 days after each injection) during this study. * Participants will be divided into two groups: one group will receive two standard (TIV) flu vaccine injections given using a needle and syringe, while the other will receive the DNA flu vaccine using a needleless injection system followed by the TIV vaccine. * The vaccine injections for both groups will be given approximately 3 weeks apart, * Clinic staff will observe participants for at least 30 minutes after each vaccination. One to two days after each injection, participants must telephone the clinic staff, and for 7 days after the vaccination participants will keep a diary card to report on possible side effects. * During study visits, blood samples will be collected for research purposes to test for responses to vaccine.

Study Details

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Interventions