COLT

STUDY BASICS

Are you a liver transplant candidate? You may be eligible for a research study to evaluate a new way to prevent or decrease complications of a common viral infection Cytomegalovirus (CMV) after liver transplant. This research is studying an experimental CMV vaccine (Triplex) that is not yet approved by the Food and Drug Administration (FDA). Compensation is provided.

STUDY PURPOSE

Cytomegalovirus (CMV) is a common virus that can cause serious infections in persons with weakened immune systems, like transplant patients. This research study is to test whether a CMV vaccine works in liver transplant patients. 

By doing this study, we hope to learn if Triplex CMV Vaccine in liver transplant is:

• effective in decreasing CMV infection after a liver transplant
• effective in reducing the need for CMV treatment after a liver transplant
• safe in liver transplant candidates

COULD THIS STUDY BE RIGHT FOR YOU?

• Are 18 years of age or older
• Are a liver transplant candidate

WHAT PARTICIPANTS CAN EXPECT

• Receive 2 intramuscular injections of the study injection (Triplex or Placebo), approximately 28 days apart
• Fill out a daily symptom survey for 7 days after each study injection
• Have blood draws on the days you receive the study injection and for up to 7 additional times: 4 prior to transplant, and 3 after transplant if applicable
• Be followed for up to 18 months (up to 12 months after getting the study injection, and up to 6 months after liver transplant if you receive a transplant within 1 year)