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

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.

Timeline

Start

2009-10-08

Primary completion

2010-09-03

Completion

2010-09-03

Publications

• Background Subbarao K, Murphy BR, Fauci AS. Development of effective vaccines against pandemic influenza. Immunity. 2006 Jan;24(1):5-9. doi: 10.1016/j.immuni.2005.12.005.
• Background Luke CJ, Subbarao K. Vaccines for pandemic influenza. Emerg Infect Dis. 2006 Jan;12(1):66-72. doi: 10.3201/eid1201.051147.
• Background Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NJ; Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep. 2009 Jul 31;58(RR-8):1-52.
• Ledgerwood JE, Hu Z, Costner P, Yamshchikov G, Enama ME, Plummer S, Hendel CS, Holman L, Larkin B, Gordon I, Bailer RT, Poretz DM, Sarwar U, Kabadi A, Koup R, Mascola JR, Graham BS; VRC 307 and VRC 309 Study Teams. Phase I clinical evaluation of seasonal influenza hemagglutinin (HA) DNA vaccine prime followed by trivalent influenza inactivated vaccine (IIV3) boost. Contemp Clin Trials. 2015 Sep;44:112-118. doi: 10.1016/j.cct.2015.08.006. Epub 2015 Aug 12.

Drugs

Indications