A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Tetravalent Recombinant Subunit Dengue Vaccine (V180) in Healthy Adults

Merck Sharp & Dohme LLC0 sites98 target enrollmentJuly 23, 2012

ConditionsDengue

Overview

This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response.

Registry

clinicaltrials.gov

Start Date

July 23, 2012

End Date

December 11, 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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