study of a dengue vaccine (v180) in healthy adults (v180-001)

Conditions: Dengue

Summary: this study will determine whether at least one formulation of an experimental dengue vaccine (v180) is safe and causes an immune response.


Eligibility criteria:
selected inclusion criteria: * in good health * voluntarily agrees to participate by giving written informed consent * able to read, understand, and complete study questionnaires * able to complete all scheduled visits and comply with study procedures * access to a telephone * agrees to avoid unusual, vigorous exercise from 72 hours before any dose of study vaccine/placebo through 15 days after that dose * weighs ≥110 pounds (50 kg) and has a body mass index (bmi) of 19 to 32 kg/m\^2 * no fever (temperature ≥100.4°f/38.0°c) for 72 hours prior to vaccination * females of reproductive potential agree to remain abstinent or to use 2 acceptable methods of birth control from enrollment through 6 weeks after the last dose of study vaccine/placebo selected exclusion criteria: * history of receiving any flavivirus vaccine (e.g. japanese encephalitis, tick-borne encephalitis, or yellow fever) or planned receipt of any such vaccine during the study period * history of any flavivirus infection or serologic evidence of any flavivirus infection, including west nile, dengue, yellow fever, saint louis encephalitis (if available), kunjin, murray valley encephalitis, and japanese encephalitis * history of residence for a cumulative period of \>1 year in a country where dengue, japanese encephalitis virus, or yellow fever virus is common * planned travel to an area where dengue is common through 28 days after receiving the last dose of study vaccine/placebo * known hypersensitivity to any component of the dengue vaccine * abuse of drugs or alcohol within 12 months prior to screening * pregnant or breastfeeding, or expecting to conceive in the time from enrollment through 6 weeks after the last dose of study vaccine/placebo * positive serum test for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), and/or hepatitis c antibody * known, suspected, or a history of immunocompromise * history of malignancy within 5 years prior to enrollment * poorly controlled diabetes mellitus * use of any immunosuppressive therapy (except topical and inhaled/nebulized steroids) * receipt of any licensed non-live vaccine within 14 days prior to the first dose of study vaccine/placebo or plans to receive a licensed non-live vaccine during the time between receiving the first dose and 28 days after receiving the last dose of study vaccine/placebo * receipt of any licensed live vaccine within 30 days prior to the first dose of study vaccine/placebo or plans to receive a licensed live vaccine during the time between receiving the first dose and 28 after receiving the last dose of study vaccine/placebo * received investigational drugs or vaccines within 2 months prior to the first dose of study vaccine/placebo * history of receiving 1 or more doses of an investigational dengue vaccine * participation in another clinical study within 42 days prior to enrollment, or plans to participate in another clinical study from enrollment through 1 year after the last dose of study vaccine/placebo * planned donation of eggs or sperm from the time of enrollment through 28 days after the last dose of study vaccine/placebo * prior receipt of a blood transfusion or blood products within 6 months prior to the first dose of study vaccine/placebo * hospitalization for acute illness within 3 months prior to the first dose of vaccine/placebo