Status:
COMPLETED
Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Dengue
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief 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
Inclusion
- Selected
- 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
- 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
Key Trial Info
Start Date :
July 23 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2014
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01477580
Start Date
July 23 2012
End Date
December 11 2014
Last Update
January 15 2019
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