A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent Influenza

Inclusion criteria

• Age 65 years of age or older
• Good general health without significant physical examination findings or clinically significant abnormal laboratory results
• Available to participate for entire study period
• Acceptable laboratory parameters
• Willingness to have blood stored for up to 10 years for use in additional assays to evaluate immune responses to influenza or the alphavirus vector if such assays become available
• Willingness to refrain from donating blood while participating in the study
• Willingness to delay receipt of 2008-2009 licensed influenza vaccination until after completing study visit 6 procedures (study week 8)
• Signed inform consent obtained before screening and before enrollment

Exclusion criteria

• Venous access deemed inadequate for th phlebotomy demands of the study
• Receipt of any other vaccine within 30 days prior to enrollment
• Use of any investigational agent within 30 days prior to enrollment
• Receipt of immunoglobulin or other blood products within 60 days prior to enrollment
• Use of cytotoxic medications within 6 months prior to enrollment
• Use of systemic corticosteroids within 6 months prior to enrollment (except that participants who have completed a course of prednisone, at up to 20 mg per day for up to 7 days, at least 1 month prior to enrollment are eligible for enrollment)
• History of serious adverse reactions to any vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain
• History of autoimmune disease or splenectomy
• History of malignancy within the last 3 years (except that participants with a diagnosis of basal cell carcinoma of the skin are eligible for enrollment)
• Psychiatric condition that may interfere with the ability to comply with the protocol requirements or to understand informed consent. Specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years.
• History of medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• Any condition which leads the investigator to believe that the particpant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for further participation.