A COVID-19 vaccine study for people who have received kidney or liver transplants

Multiple Locations

Overview

The purpose of this study is to evaluate an investigational vaccine that may prevent illness after exposure to SARS-CoV-2, which causes COVID-19. There will be two participant groups in this study – a group of individuals who have had a solid organ transplant and are immunocompromised from the transplant, and a control group of individuals who are in good health. The control group is included as a comparison group to help understand how immune cells act after vaccination. Both groups will receive the COVID-19 vaccine.

Participation in the COVE Transplant Study Part B may be up to 6 months and includes up to 5 visits to the study site and 6 phone calls.

Inclusion Criteria

  • At least 18 years old
  • Have received either a kidney transplant or a liver transplant at least 90 days before the screening period
  • Have received chronic immunosuppressive therapy for the prevention of organ rejection for a minimum of 90 days
  • Have received one of the following:
    • Two doses of the Moderna COVID-19 vaccine after transplant at least one month ago
    • Three doses of an mRNA COVID-19 vaccine (Moderna/Pfizer) after transplant at least four months ago
    • Two doses of a non-mRNA COVID-19 vaccine (Janssen/J&J) after transplant at least four months ago
    • One dose of a non mRNA COVID-19 vaccine (Janssen/J&J) combined with one dose of an mRNA COVID-19 vaccine (Moderna/Pfizer) after transplant at least four months ago

Other inclusion/exclusion criteria may apply.

Locations:

Washington:
University of Washington Medical Center

Seattle, WA 98195

 

California:
California Institute of Renal Research

San Diego, CA 92123

 

Arizona:
Aventiv Research Inc. Phoenix, HyperCore

Mesa, AZ 85210

 

Nebraska:
University of Nebraska Medical Center

Omaha, NE 68198

 

Iowa:
University of Iowa Hospitals and Clinics

Iowa City, IA 52242

 

Georgia:
Piedmont Research Institute

Atlanta, GA 30309

 

Florida:
Tampa General Medical Group

Tampa, FL 33606

 

Pennsylvania:
Hospital for the University of Pennsylvania

Philadelphia, PA 19104

 

New York:

Columbia University Medical Center

New York, NY 10032

 

Connecticut:

Yale

 

New Haven, CT 06510

 

Rhode Island:
Rhode Island Hospital

Providence, RI 02903

 

Massachusetts:
Brigham and Women’s Hospital

Boston, MA 02115

 

University of Massachusetts Medical School

Worcester, MA 06155