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

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

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

What this study is about

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

What this study is about