Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults
Condition: West Nile Fever
MeSH terms: West Nile Fever
Intervention: ChimeriVax-WN02 vaccine; ChimeriVax-WN02 vaccine; ChimeriVax-WN02 vaccine; Placebo
Intervention description: low dose, approximately 4 x 3log10, given one time subcutaneously; medium dose, approximately 4 x 4log10, given one time; high dose, approximately 4 x 5log10, given one time subcutaneously; 0.9%Normal Saline for Injection, given one time subcutaneously
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 479.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: West Nile Fever; ChimeriVax; West Nile Virus Vaccine

Summary:

      The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and
      effective in preventing West Nile disease in adults over 50 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Medically stable, ambulatory male or female ≥ 50 years of age.

          -  Attend all scheduled visits and to comply with all study procedures.

          -  Negative serum pregnancy test at Screening, and a negative urine pregnancy test on Day
             0.

        Exclusion Criteria:

          -  Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
             such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
             or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids
             therapy (at a dose of at least 10 mg of prednisone or equivalent), or depot
             preparation within the previous 3 months. Topical steroids are allowed.

          -  Administration of immunoglobulins and/or any blood products within 3 months before
             enrollment or planned administration during treatment period of study.

          -  Presence of acute or chronic illness associated with an oral temperature of >38.0 °C
             or requiring hospitalization at time of enrollment.

          -  Any of the following serological findings at Screening:

        positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C (anti-HCV), or positive
        human immunodeficiency virus (HIV).

          -  Personal or family history of thymic pathology (e.g., thymoma), thymectomy, or
             myasthenia.

          -  History of significant allergic reaction to the vaccine components

          -  Asplenia, functional asplenia, or any condition resulting in the absence or removal of
             the spleen.

          -  Active or potentially progressive neurologic disease or injury including but not
             limited to: Parkinson's, Guillain Barré, epilepsy, seizures (except febrile seizures
             under the age of 2), cerebrovascular accident, head trauma requiring hospitalization
             within the preceding 3 years, or any other neurologic condition thought to impact the
             integrity of the blood brain barrier.

          -  Clinically significant abnormal ECG findings at Screening

          -  Impaired hepatic function, and/or clinically significant or unexplained elevations of
             alanine aminotransferase (ALT, SGPT), or aspartate aminotransferase (AST, SGOT) > 3X
             the upper limit of normal.

          -  Impaired renal function, as shown by but not limited to, serum creatinine >2.0 mg/dL.

          -  Impaired hematopoietic function and/or clinically significant hematological laboratory
             abnormalities.

          -  A history of alcohol or drug abuse within 12 months prior to study entry.

          -  Pregnant or lactating women and women of childbearing potential who are not using an
             acceptable method of contraception at least 28 days prior to enrollment. Post
             menopausal women will be considered not of childbearing potential 1 year after last
             menstrual period.

          -  Behavioral, cognitive, or psychiatric disease that, in the opinion of the Investigator
             affects the ability of the subject to understand the scope of the study and/or
             unlikely to be able to be compliant with the study procedures and visits.

          -  Any other condition, which in the Investigator's judgment, might result in an
             increased risk to the subject, or would affect the subject's participation in the
             study.

          -  Participation in another clinical trial investigating a vaccine, drug or medical
             procedure in the 30 days preceding informed consent.

          -  Any vaccine administered within 30 days prior to study vaccination. Note: Influenza
             vaccine can be administered 1 week preceding study vaccination.

          -  Planned participation in another clinical trial during the present trial period.

          -  Planned receipt of any vaccine in the 4 weeks following the trial vaccination.

          -  Research site personnel or their family members cannot be enrolled as subjects in this
             trial.