COVID Protection After Transplant-Immunosuppression Reduction (CPAT-ISR)

STUDY BASICS

Have you had a kidney or liver transplant more than 1 year ago without rejection? Do you want to know if you have immunity to COVID-19? You may be eligible to participate in a research study to help us learn whether an additional dose of COVID-19 study vaccine with or without lowering an anti-rejection medicine can help transplant recipients make more antibody to COVID-19.

STUDY PURPOSE

The purpose of the study is to find out whether an extra dose of COVID-19 study dose of vaccine will help to protect people who have had a liver or kidney transplant from COVID-19 by causing their body to make antibodies against the virus that causes COVID-19. Many transplant recipients either do not make antibodies after receiving 2 or more doses of the COVID-19 vaccine, or make very low levels of antibodies compared with people who are not receiving anti-rejection medications. This means that they are more likely to get infected with COVID-19 and more likely to become seriously ill if they do get infected with COVID-19. This study will help us learn whether an additional dose of COVID-19 study vaccine with or without lowering an anti-rejection medicine can help transplant recipients make more antibody to COVID-19.

COULD THIS STUDY BE RIGHT FOR YOU?

• Are at least 18 years old
• Had a kidney or liver transplant more than 1 year ago without rejection
• Received at least 2 COVID-19 vaccines

WHAT PARTICIPANTS CAN EXPECT

This trial will give all participants an additional dose of the Pfizer or Moderna vaccine and some participants will also have a temporary lowering of their immunosuppression medications around the time of the COVID-19 vaccine to see if this helps them develop more antibodies.  Immunosuppression changes will be done in partnership with your transplant provider and with close monitoring to check on your transplanted organ. Study participants will have up to 13 visits depending on which group they are assigned to.