A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers

Inclusion Criteria:

1. Male or female at least 18 years and ≤ 45 years old at time of screening
2. In good health as determined by medical history, physical examination including height and weight
3. Normal clinical safety laboratory examinations (Na, K, Glucose, BUN, creatinine, ALT, AST, total bilirubin, WBC, neutrophil count, hemoglobin, platelets, PT, PTT, and urinalysis (by dipstick)).
4. Weight: Body Mass Index (BMI) ≤32
5. Blood tests negative for antibodies to HIV-1, Hepatitis C, and Hepatitis B surface antigen

Exclusion Criteria:

1. Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator
2. Clinically significant ECG findings
3. History of any significant dermatologic disease in the last 6 months,
4. History of diabetes mellitus
5. History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines
6. Hypersensitivity to any vaccine
7. Receipt of any vaccine in the 4 weeks preceding the first vaccination
8. Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study
9. Known history of Japanese Encephalitis Virus (JEV) and/or Yellow Fever (YF)
10. Previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, yellow fever (YF) and Japanese Encephalitis (JE)
11. Seropositivity to dengue or West Nile (WN) virus
12. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months
13. Use within the previous 6 months of systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or within the last 3 months. Note, inhaled prednisone (or equivalent) is allowed
14. Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination
15. Use of any prescription or over the counter medications (besides those specifically mentioned above or those required for medical management of concurrent diseases) 7 days before the first vaccination (Day 0)
16. Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids
17. Donation of blood 6 weeks before the first dose(s) (Day 0) until 30 days after the dose on day 90
18. Females who are pregnant or lactating