Evaluating the Safety and Effectiveness of a Dengue Virus Vaccine in Healthy Adults

Exclusion Criteria

• •Females Only: Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test, breast-feeding
• •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 participant to understand and cooperate with the requirements of the study protocol
• •Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine as defined in the study protocol.
• •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant 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 participant history
• •History of a severe allergic reaction or anaphylaxis
• •Severe asthma (emergency room visit or hospitalization within the last 6 months)
• •HIV infection, by screening and confirmatory assays
• •Hepatitis C virus (HCV) infection, by screening and confirmatory assays
• •Hepatitis B virus (HBV) infection, by hepatitis B surface antigen (HBsAg) screening
• •Any known immunodeficiency syndrome
• •Use of anticoagulant medications
• •Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. Immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for 14 days or longer.
• •Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 28 days following vaccination
• •Asplenia
• •Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination
• •History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis virus, West Nile virus)
• •Previous receipt of a flavivirus vaccine (licensed or experimental)
• •Anticipated receipt of any investigational agent in the 28 days before or after vaccination
• •Participant has definite plans to travel to a dengue endemic area during the study
• •Refusal to allow storage of specimens for future research
• •Anaphylaxis or angioedema following the first dose of vaccine
• •Females Only: Currently pregnant, as determined by positive beta-HCG test, breast-feeding
• •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 participant to understand and cooperate with the requirements of the study protocol
• •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant 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 participant history
• •History of a severe allergic reaction or anaphylaxis
• •Severe asthma (emergency room visit or hospitalization within the last 6 months)
• •HIV infection, by screening and confirmatory assays
• •HCV infection, by screening and confirmatory assays
• •HBV infection, by HBsAg screening
• •Any known immunodeficiency syndrome
• •Use of anticoagulant medications
• •Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. Immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for 14 days or longer.
• •Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 28 days following vaccination
• •Asplenia
• •Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination
• •Anticipated receipt of any other investigational agent in the 28 days before or after vaccination
• •Participant has definite plans to travel to a dengue endemic area during the study
• •Refusal to allow storage of specimens for future research
• •The following criteria will be reviewed on Study Days 28 and 56 following each vaccination. If any become applicable during the study, the participant will not be included in further immunogenicity evaluations, as of the exclusionary visit. The participant will, however, be encouraged to remain in the study for safety evaluations for the duration of the study.
• •Use of any investigational drug or investigational vaccine other than the study vaccine during the 28-day period after vaccination
• •Chronic administration (14 days or longer) of steroids (defined as prednisone equivalent of greater than or equal to 10 mg per day), immunosuppressants, or other immune-modifying drugs initiated during the 28-day period after vaccination (topical and nasal steroids are allowed)
• •Receipt of a licensed vaccine during the 28-day period after vaccination
• •Receipt of immunoglobulins and/or any blood products during the 28-day period after vaccination
• •Pregnancy