Evaluating the Safety and Immunogenicity of a Live Attenuated West Nile Virus Vaccine for West Nile Encephalitis in Adults 50 to 65 Years of Age

Exclusion Criteria

• •Pregnancy, as determined by positive beta-human choriogonadotropin (HCG) test (if female)
• •Currently lactating and breastfeeding (if female)
• •Participant is unwilling to use reliable contraception methods for the duration of the trial (reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; intrauterine device; abstinence; and post-menopausal documented for at least 1 year). All female participants will be considered as having childbearing potential except for those with documented hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or who are post-menopausal for at least 1 year since last menstrual period.
• •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
• •Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
• •Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol
• •Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
• •Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• •History of a severe allergic reaction or anaphylaxis
• •Severe asthma (emergency room visit or hospitalization within the last 6 months)
• •Positive HIV-1 serology by screening and confirmatory assays
• •Positive for hepatitis C virus (HCV) by screening and confirmatory assays
• •Hepatitis B virus (HBV) infection, by positive hepatitis B surface antigen (HBsAg)
• •Any confirmed or suspected immunosuppressive or immune modulating disorder (e.g., asplenia, lupus, rheumatoid arthritis, vasculitis, scleroderma, and diabetes mellitus)
• •Chronic administration (greater than or equal to 14 days) of steroids (defined as prednisone equivalent of greater than or equal to 10 mg per day), immunosuppressants, or other immune-modifying drugs initiated during the 28-day period post-vaccination (topical and nasal steroids are allowed)
• •Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 28 days following vaccination
• •History of a surgical splenectomy
• •Receipt of blood products within the past 3 months, including transfusions or immunoglobulin, or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination
• •History or serologic evidence of previous WNV infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis virus, and dengue virus)
• •Previous receipt of yellow fever, WNV, or dengue vaccine (licensed or investigational)
• •Receipt of any investigational agent in the past 28 days or anticipation of receipt of any investigational agent within 28 days following vaccination
• •Refusal to allow storage of specimens for future research
• •Anaphylaxis or angioedema following the first dose of vaccine
• •Females only: currently pregnant, as determined by positive beta-HCG test, or breastfeeding
• •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
• •Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the requirements of the study protocol
• •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
• •Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by participant history
• •History of a severe allergic reaction or anaphylaxis
• •Severe asthma (emergency room visit or hospitalization within the last 6 months)
• •HIV infection, by screening and confirmatory assays
• •HCV infection, by screening and confirmatory assays
• •HBV infection, by HBsAg screening
• •Any confirmed or suspected immunosuppressive or immune modulating disorder (e.g., asplenia, lupus, rheumatoid arthritis, vasculitis, scleroderma, or diabetes mellitus)
• •Current use of anticoagulant medications
• •Chronic administration (greater than or equal to 14 days) of steroids (defined as prednisone equivalent of greater than or equal to 10 mg per day), immunosuppressants, or other immune-modifying drugs initiated during the 28-day period post-vaccination (topical and nasal steroids are allowed)
• •Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 28 days following vaccination
• •History of surgical splenectomy
• •Receipt of blood products within the past 3 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination
• •Receipt of any other investigational agent in the 28 days before vaccination or anticipated within 28 days following vaccination
• •Refusal to allow storage of specimens for future research