This study is no longer recruiting participants.
We are enrolling members of the public in a clinical trial of a Phase 3 vaccine for the prevention of COVID-19. Our research site is testing the SARS-CoV-2 recombinant spike protein nanoparticle vaccine that is now being developed as part of Operation Warp Speed by a new NIH network – the Coronavirus Prevention Network, or CoVPN – and Novavax as the pharmaceutical partner. Additional information about the vaccine and the first publication describing the safety and immune response to this vaccine in people is available here. The New York Times also has an excellent article describing this vaccine, available here.
If you are interested in participating in this trial, visit the CoVPN website for additional information and to sign up! This is a secure mechanism for us to learn a bit about you and see whether you would be a good fit. If you live in the Seattle metropolitan area, please provide the site code UWVR to request that your information is securely available to our clinic. You can also contact us directly at 206-520-4212 or email us at vteu+novavax@uw.edu. We are anticipating a high level of interest in the study, so we recommend filling out the online questionnaire to help us contact you more quickly.
Because we are committed to keeping everyone safe and healthy, we will strive to keep the in-person visits as short as possible. We will email you a digital copy of the consent form to read so you can come prepared with questions when you see us.
Your visit will involve a meeting with a research coordinator and a clinician. We will make sure that you understand the study, answer your questions about it, and that you sign an informed consent form. You will be asked questions about your health and a physical examination will be conducted along with a blood draw for screening laboratory tests. We will also take a swab of your nose, similar to the COVID test, in case you develop symptoms in the week following your visit. If you are eligible to participate in the study, you will receive an experimental vaccine or placebo in your upper arm. Of every 3 people who enroll, 2 will receive the study vaccine and 1 will receive placebo (salt water) – which one you receive will be decided randomly, like flipping a coin. Neither you nor the study staff will know you which one you received. Your first visit will take approximately 2-3 hours. You will also receive another dose of the vaccine three (3) weeks after your first dose. Altogether, you will be followed for two (2) years after vaccination, with approximately eight (8) in-person visits. You will be asked each day about any symptoms that may be related to COVID-19 and to record your temperature on a phone app. If you develop symptoms of COVID-19, please notify us so we can help you get tested and make sure you receive appropriate medical care.