Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device

Inclusion Criteria

• Provide written informed consent before initiation of any study procedures.
• Are able to understand and comply with planned study procedures and be available for all study visits/phone calls.
• Males or non-pregnant females ages 18-49, inclusive.
• Are in good health*. *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, ER or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (apart from steroids as outlined in the Subject Exclusion Criteria), herbals, vitamins, and supplements are permitted.
• Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
• Pulse is 47 to 105 beats per minute (bpm), inclusive.
• Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
• Diastolic blood pressure (BP) is 55 to 95 mm Hg, inclusive.
• Have acceptable screening laboratories* within 28 days prior to enrollment. *Screening laboratory values that are outside acceptable range but are thought to be due to an acute condition or due to laboratory error may be repeated once.
• Urine protein screen is negative or trace.
• Drug screen for opiates is negative.
• HgbA1C 1 year prior to screening
• Must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream or partner reports usage of occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
• Women agree to not donate eggs (ova, oocytes) and male subject agrees not to donate sperm from the start of screening onwards until at least 90 days after the last vaccination.
• Agree not to participate in another clinical trial during the study period.
• Agree not to donate blood to a blood bank for 3 months after receiving the last study vaccine.

Exclusion Criteria

• Women who are pregnant, planning to become pregnant or lactating*. *Includes breastfeeding or planning to breastfeed at any given time from the receipt of study vaccination through the 12-month trial period.
• Known allergy or history of anaphylaxis, severe local or other serious adverse reactions to vaccines or vaccine products*, or history of severe allergic reactions.

*This includes a known allergy to an aminoglycoside (e.g., gentamicin, t