Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

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