Building on its success with previous COVID-19 vaccine studies, the University of Kentucky has been selected as a site for a trial to assess dose levels of a Johnson & Johnson booster shot.

Currently authorized vaccines remain overwhelmingly effective against severe illness from COVID-19, but the virus’ evolution requires us to understand if and when boosters will be needed, and if we can mix vaccine types in the process. By including people who received the Johnson & Johnson vaccine and people who received Pfizer, this Phase 2 study will begin to provide answers about the best vaccine regimens for keeping us safe. Approximately 660 participants will be enrolled at sites across the country.

Adults who received two doses of the Pfizer vaccine by the end of February 2021 and participants in UK’s previous study of Johnson & Johnson’s single-dose vaccine may be eligible to join in this booster study.

Participants will be randomized to receive one of three booster regimens, and their immune response will be monitored through a few blood samples over the course of the study. Participants will also be asked to keep notes in a smartphone app. The study team closely monitors the health of volunteers, and compensation is provided.

Dr. Richard Greenberg, who has more than 40 years of international vaccine development trial experience, leads this booster study and three other vaccine trials at UK. Dr. Philip Kern, director of the UK Center for Clinical and Translational Science (CCTS), and Dr. T. Shawn Caudill serve as co-investigators.

“At this time, the COVID-19 vaccines are working well, but it’s critically important to study boosters so that we can stay ahead of the coronavirus and its variants," Greenberg said.

The UK CCTS is implementing Greenberg’s COVID-19 vaccine studies and also provides support for the KidCOVE pediatric vaccine study at UK HealthCare’s Kentucky Children’s Hospital.

“We are all enjoying going back to some semblance of our normal lives, but we need to know more about COVID-19 booster shots,” Kern said. “The UK CCTS is here to help make important studies such as this happen, and we’re happy to play a part in ensuring the health of Kentuckians.”

More information and an eligibility survey for the vaccine booster trial are available at StopCOVIDKy.com under the booster study button.

The StopCOVIDKy.com site is an up-to-date hub for information on other COVID-19 vaccine and transmission studies enrolling participants at UK.

The study is sponsored by Janssen Vaccines & Prevention B.V., a Janssen pharmaceutical company of Johnson & Johnson.

The UK Center for Clinical and Translational Science is funded by a Clinical and Translational Science Award from NCATS at the National Institutes of Health.