Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3delta30/31-7164) in Healthy Adults

Inclusion Criteria:

• Adult male or non-pregnant female between 18 and 50 years of age, inclusive.
• Good general health as determined by physical exam, laboratory screening, and review of medical history
• Available for the duration of the study, approximately 26 weeks post-vaccination
• Willing to use effective means of contraception for the duration of the trial

Exclusion Criteria:

• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the requirements of the study protocol
• Grade 1 or above values for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as protocol defined
• Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating n the trial or would render the volunteer unable to comply with the protocol
• Any significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by volunteer history
• History of a severe allergic reaction or anaphylaxis
• Severe asthma (emergency room visit or hospitalization within the last 6 months)
• Positive HIV-1 serology by screening and confirmatory assays
• Positive for hepatitis C virus (HCV) by screening and confirmatory assays
• Positive for hepatitis B virus (HBV) by hepatitis B surface antigen (HBsAg) screening
• Any known immunodeficiency syndrome
• Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days prior to Study Day 0
• Receipt of a live vaccine within 4 weeks or a killed vaccine within the 2 weeks prior to Study Day 0 or anticipated receipt of any vaccine during the 42 days following Study Day 0
• History of a surgical splenectomy
• Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following Study Day 0
• History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
• Previous receipt of yellow fever or dengue vaccine (licensed or experimental)
• Receipt of any investigational agent in the 30 days prior to Vaccination Day 0 or plan to participate in any investigational drug trials during the next 26 weeks
• Definite plans to travel to a dengue endemic area
• Pregnancy or breastfeeding