Dengue
Conditions
Brief summary
This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response.
Interventions
BIOLOGICALMedium-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of medium-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICALMedium-dose V180 with Alhydrogel™ adjuvant
Three 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2
BIOLOGICALHigh-dose V180 (non-adjuvanted)
Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2
BIOLOGICALHigh-dose V180 with low-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of high-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICALHigh-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of high-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICALLow-dose V180 with low-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of low-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICALLow-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of low-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICALMedium-dose V180 (non-adjuvanted)
Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2
BIOLOGICALMedium-dose V180 with low-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of medium-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICALLow-dose V180 with high-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of low-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICALMedium-dose V180 with high-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of medium-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICALHigh-dose V180 with high-dose ISCOMATRIX™ adjuvant
Three 0.5-mL intramuscular doses of high-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICALPlacebo
Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rate for each serotype | 28 days postdose 3 (Day 84) |
| Geometric mean titer (GMT) of virus neutralizing antibodies for each serotype | 28 days postdose 3 (Day 84) |
Outcome results
None listed