Evaluating the Safety and Immune Response to Two Doses of a Dengue Virus Vaccine Administered 12 Months Apart

Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test, or breastfeeding

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 this protocol

Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant 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 that 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 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 greater than or equal to 14 days.

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 investigational agent in the 28 days before or after vaccination

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

Currently pregnant (as determined by positive beta-HCG test), breastfeeding, or, for those of childbearing potential, no longer using a reliable method of contraception

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

Day 330 laboratory values of Grade 1 or above for serum ALT and creatinine, as defined in this protocol

Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant 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 that 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 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 greater than or equal to 14 days.

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

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 Days 28, 56, and 90 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 post-vaccination

Chronic administration (greater than or equal to 14 days) 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 post-vaccination (topical and nasal steroids are allowed)

Receipt of a licensed vaccine during the 28-day period post-vaccination

Receipt of immunoglobulins and/or any blood products during the 28-day period post-vaccination

Pregnancy

What this study is about