The Vaccine Transition Option offers all participants 16 years and older the choice to learn whether they received the investigational vaccine or placebo, and for participants who learn they received the placebo, to have the option to receive the investigational vaccine while staying in the study.
Vaccine doses for placebo recipients have been secured, and our aim is that all participants 16 years and older who received the placebo will have the opportunity to receive thier first dose of the investigational vaccine within the study by March 1, 2021, if they choose this option.
How the Vaccine Transition Option works:
- All participants 16 years and older who received the placebo have two doses of the investigational vaccine reserved for them within the study.
- The study doctor will follow the latest guidance from the U.S. Centers for Disease Control and Prevention and their local health authorities to offer the Vaccine Transition Option to participants in a prioritized manner.
- If you choose the Vaccine Transition Option, your study site will schedule a time for you to be unblinded (that is, learn whether you were in the investigational vaccine or placebo group) at the appropriate time in the coming weeks.
- If you find out that you were in the placebo group and would like to receive the investigational vaccine, you will have an in-person visit where you will be provided with a new informed consent document that the study doctor will review with you before you sign it. Then, you will receive your first dose of the investigational vaccine.
- You will receive a second dose of the investigational vaccine about 21 days later and follow an updated study schedule that includes follow-up and illness visits.
The Decision To Transition To The Vaccine Group Is Up To You
Your continued participation in the trial will provide valuable contributions to the understanding of COVID-19 and the investigational vaccine. The Vaccine Transition Option is completely voluntary, and you can also choose to remain blinded and continue with your planned study activities. If you would like to learn more about the Vaccine Transition Option and how it works, please contact your study site.