Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

Inclusion Criteria

• Available to participate for the duration of the study (approximately 12 months)
• Completion and review of knowledge assement quiz

Exclusion Criteria

• Pregnant (by history or as ascertained by pregnancy test) or lactating female
• Female who intends to become pregnant during the study
• Plan to have elective surgery during the study period
• HIV infection
• Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed)
• History of splenectomy
• Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination
• Evidence of active (acute or chronic) hepatitis B or C infection
• Autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease
• Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening
• Clinical or laboratory evidence of significant anemia
• History of flavivirus infection or previous receipt of flavivirus vaccine
• Positive serology for flaviviruses (all four dengue virus serotypes, Japanese encephalitis, Yellow fever virus, and West Nile virus), HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus antibodies prior to enrollment
• Use of any investigational or non-registered drug or vaccine other than the study vaccine within 60 days preceding the first dose of study vaccine, or planned use during the study period.
• Previous history of allergic or anaphylactic reaction to any vaccine
• Planned travel to areas with endemic dengue during the study period
• Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol