STUDY BASICS
Adults who have not yet been vaccinated for COVID-19 may be able to participate in a research study to find out if receiving a COVID-19 vaccine booster shot improves your immune response to prevent infection longer, more effectively, and/or from more variants. Participants in this study will receive initial COVID-19 vaccination and will later receive a vaccine booster. Compensation provided.
STUDY PURPOSE
For many infectious diseases, an extra dose of vaccine (also called a “booster shot”) is needed after initial vaccination to ensure lasting protection against infection. Some research suggests that COVID-19 booster shots may be beneficial for people who have been vaccinated for COVID-19, but these effects are not fully understood.
The purpose of this research study is to learn about the safety, side effects, and immune responses associated with COVID-19 booster shots. This study uses vaccines that have received emergency use authorization from the United States Food and Drug Administration (FDA) and vaccines that are still under investigation.
COULD THIS STUDY BE RIGHT FOR YOU?
- Ages 18 and up
- Healthy (participants with stable pre-existing disease are eligible)
- Have not received a COVID-19 vaccine
- Have never been diagnosed with COVID-19
- Not currently pregnant or breastfeeding
WHAT PARTICIPANTS CAN EXPECT
Participants will receive the Moderna COVID-19 vaccine at the same dose and schedule (two doses, 28 days apart) as is currently approved for use under the emergency use authorization by the United States Food and Drug Administration (FDA). Participants will attend 11 or 12 study visits, including an initial screening visit, 3 study vaccination visits (the first vaccination may be combined with initial screening visit), and 8 follow-up visits including 7 in-person visits and a phone call. All study visits will include a blood draw, and some may include a physical exam.
IRB: SSU00150890B
- NIH/NIAID/DMID - 21-0012, A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) after Receipt of EUA Vaccines (Pro00053376)MEET THE RESEARCHER
Judy Martin
Judy Martin, MD is a Professor of Pediatrics in the Division of General Academic Pediatrics at the University of Pittsburgh School of Medicine. A graduate of the University of Pennsylvania and Mount Sinai Icahn School of Medicine, Dr. Martin’s research interests include vaccine research, Group A streptococcal infections, and rheumatic fever.