Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines

Exclusion Criteria

• •History or serologic evidence of prior infection with either HTNV or PUUV virus, or prior participation in a HTNV or PUUV virus vaccine trial
• •History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
• •Any serologic evidence of hepatitis B or C infection
• •Ongoing participation in another clinical trial
• •Receipt or planned receipt of any vaccination, experimental or otherwise, within the period 30 days prior to initial injection through 60 days after the Day 70 follow-up (approximately a 6 month period in total)
• •Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid region) exceeds 40 mm
• •Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
• •Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, EKG, and/or laboratory screening test
• •Pregnant or lactating female, or female who intends to become pregnant during the study period
• •Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
• •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection
• •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within 6 months of study entry
• •* For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
• •* Inhaled and topical steroids are allowed
• •Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child
• •Syncopal episode within 12 months of screening
• •Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV (Diagnostic and Statistical Manual of Mental Disorders-4th edition)
• •Chronic or active illicit and/or intravenous drug use
• •Unwilling to allow storage and use of blood for future hantavirus-related research
• •Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study