This study involves comparing an investigational (study) vaccine against a placebo (injection with no active ingredient) to see if the vaccine can prevent COVID-19. The vaccine is given by injection.
Participants 12 and older who are in good general health and have not been previously diagnosed with COVID-19 can participate in the study. Enrollment for those 16 and older is complete. However, we are currently enrolling 12-15 year olds.
The study doctor will also assess if you are at risk of COVID-19 infection before you can participate. Things the study doctor may consider include the type of work you do, your lifestyle and any medical conditions you may have.
What to Expect
You will be randomly assigned (by chance) to receive either the study vaccine or placebo. This assignment will be made by a computer and not by the study team. Neither you nor the study doctor will know if you are receiving the study vaccine or a placebo.
One half of the study participants will receive the study vaccine, and the other half will receive the placebo. You will receive 2 injections about 3 weeks apart. You also will be asked to record and report any changes to your health over time and have follow-up study visits.
- At each of the 6 planned study visits, the study team will ask about your general health and complete study procedures.
- The first 2 visits are when you receive the study vaccine or placebo through an injection in your arm. The first visit includes taking a blood sample, and both visits include taking a COVID-19 test.
- It is important that you return for the second visit to get the second injection.
- After you receive your study vaccinations, there are 4 planned follow up study visits over 2 years to monitor your health.
- Over the course of the study, you will need to track any side effects that you may have. To make this easier, you will be given an electronic diary (e-diary). If you prefer, you can also download a secure app on your smart phone.
- During the study, if you have any symptoms you think may be caused by COVID-19, you should contact your study team right away. They will advise you if you need to take a COVID-19 test.
- You will be reimbursed for expenses (such as parking, meals, travel) and time related to completing the e-diary.