Currently, there are no approved vaccines available to prevent COVID-19 and the disease has spread across the world. The COVID vaccine we are studying at Yale has already been studied in thousands of people for dosing and safety. This round is the largest so far to help determine how well the vaccine works and identify any new more rare side effects. Each and every person involved in clinical research plays a powerful role. Volunteering for this study can make a difference as we try to find potential vaccines to prevent COVID-19.
About This Study
This study will take place in 3 stages and involves testing a placebo against multiple investigational vaccines, at different dose levels (amounts of vaccine), to try and prevent COVID-19. Each vaccine is slightly different, but is intended to work in the same way. All are given by injection.
What to Expect
You will be randomly assigned (by chance) to receive the study vaccine or placebo (inactive substance). This assignment will be made by a computer and not by the study team. Neither you nor the study doctor will be told which group you are in nor, if you are receiving a vaccine, which one it is. In the event of an emergency, the study team will quickly find out this information.
Each participant will receive 2 injections. Some participants will receive their injections 3 weeks apart and some will receive their injections 2 months apart. The study doctor will explain to participants when they will have their two injections. The study team will be able to schedule the appointments.
• At each study visit, the study team will ask about your general health and complete study procedures such as a physical exam or taking your blood pressure
• On injection days, the study vaccine or placebo will be given through an injection into the muscle of the upper arm and nasal swabs will be collected
• After the injection, you will be asked to wait at the study site for at least 30 minutes
• Blood samples will be taken at up to 9 planned study visits. Each time, about 25mL (5 teaspoons) of blood will be collected
• The study team will provide you with nasal swabs and instruct you on how to take a swab from your nose at home if you experience symptoms that might be caused by COVID-19 while enrolled in
☑ An electronic diary (e-diary) (a device or app on your phone)
☑ A digital thermometer
☑ A caliper (a device to measure any redness and swelling at the injection site)
You will complete the e-diary once a day for 7 days after receiving study injection to record specific reactions you may experience. If you experience potential COVID-19 symptoms while you are enrolled in this study, please contact your study doctor immediately.
Q&A: We Are Here to Help
We want to make sure that any questions you have are fully answered. If you have questions or concerns about anything related to this vaccine research study as you consider volunteering, please let the study team know. If you do not have questions now you can call the study site or send the study team an email using the contact details below at any time