Combination HTNV and PUUV DNA Vaccine

Inclusion Criteria

• Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at time of screening
• Have demonstrated adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given the opportunity to retest after a review of the protocol information. Individuals who fail the quiz for the second time will not be enrolled.
• Have provided written informed consent before screening
• Subject is in good health as determined by past medical history, medication use, and abbreviated physical examination
• Good health is defined by the absence of any medical condition described in the exclusion criteria in a subject with a normal abbreviated physical examination including vital signs. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria: (1) first diagnosed within 3 months of enrollment, (2) is worsening in terms of clinical outcome in last 6 months, or (3) involves need for medication that may pose a risk to subject's safety or impede assessment of adverse events or immunogenicity if they participate in the study.
• An abbreviated physical examination differs from a complete physical examination in that it does not include a genitourinary and rectal examination.
• Available and able to participate for all study visits and procedures
• Sexually active men and women of childbearing potential must agree to use an effective method of contraception from 30 days prior to the first study vaccination until 6 months after the last study vaccination.
• A sexually active man is defined as one whose partner is a woman of childbearing potential (see definition below) and has not had a vasectomy performed > 1 year prior to screening. They must agree not to father a child until 6 months after the last vaccination. These subjects must agree to use a barrier method of birth control (eg, either condom with spermicidal foam/gel/film/cream or partner usage of occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository).
• Women of childbearing potential are defined as those who have not been sterilized via tubal ligation, bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with history of documented radiological confirmation test at least 90 days after the procedure and are still menstruating or 11.0 g/dL for women; > 12.9 g/dL for men
• CBC (WBC and platelet) with differential either within institutional normal range or Grade 1 deviation from normal and deemed clinically insignificant
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.25x upper limit of normal (ULN)
• Serum creatinine ≤ ULN
• Subjects with autoimmune disorders or chronic inflammatory disorders with a potential autoimmune correlation.
• Receipt of immunoglobulins and/or any blood products within the 120 days preceding screening or planned administration during the study period
• Donation of blood to a blood bank within 56 days prior to screening and at any time during the study period.
• Subject seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (anti-HCV).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, or use of anticancer chemotherapy or radiation therapy (cytotoxic) in the 3 years prior to screening.