If you decide to take part in this research study, you will need to attend approximately 35 appointments with the study team over 4 months. These appointments may be a combination of in-person and over the phone. Most of the appointments will occur in the first month.
You will be randomly assigned to receive the investigational oral medicine (study drug) or placebo. The investigational medicine is being studied for use as a potential treatment or prevention for dengue fever. The placebo looks like the study drug but does not contain any active ingredients. You will take the study drug or placebo two times per day.
You will receive an injection containing a modified dengue virus that has been used in previous clinical trials. Your health will be closely monitored throughout the study, and you will receive appropriate medical care if severe symptoms develop.
If you are in the first group, you will take the study drug or placebo before receiving the dengue virus injection, and you will continue taking twice daily doses for 3 weeks after. If you are in the second group, you will not start taking the study drug or placebo until one week after your injection, and you will continue taking daily doses for 2 weeks. During this time, you will have regular visits with the study team so they can monitor your health, including potential side effects from the study drug or signs/ symptoms of dengue fever. The study team will also collect blood and saliva samples to measure the amount of dengue virus in your body.
Participating in this study is completely voluntary. You can choose to leave the study at any time, for any reason. Compensation up to $3,750 for study-related time and activities is available.