HEALTHY VOLUNTEERS NEEDED FOR INVESTIGATIONAL COVID STUDY
The Center for Vaccine Development and Global Health (CVD) is exploring innovative ways to improve vaccines targeting the virus that causes COVID-19. This is a phase 1 study to evaluate three dose levels of a COVID-19 vaccine to see how safe and effective each one is in prompting an immune response in people. We are looking for 30 healthy people who have received at least 2 primary doses and a booster of a COVID-19 mRNA vaccine to receive one of the 3 dose levels of the new vaccine. 12 months after the first dose, participants will be offered a second booster dose. This study will last approximately 13-25 months, depending on the number of vaccine doses participants choose to receive.
The study product is an intramuscular injection that will be delivered on the second study visit. Participants will keep an electronic diary to assess any symptoms or adverse events. If a participant chooses to continue to dose 2, that injection will be given on the 9th study visit. Participation with each vaccine dose involves 9 outpatient visits over a 13-month period including screening, vaccination day, and follow-up visits. Compensation for this study is up to $2,125 total for the two doses. Payments will be dispersed by check after completed visits.
The duration of the study for participants that only receive the first dose is approximately 13 months including 30-day screening and enrollment period, and 12 months for follow up.
The duration of the study for participants that receive both the first dose and the second dose is approximately 25 months including a 30-day screening and enrollment period, and 24 months for follow up.
We hope to find out more information regarding the tolerability of the vaccine as well as its effectiveness in generating vaccine-specific immune responses.
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