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

A research study conducted by Moderna is testing an investigational vaccine that may protect people who have received kidney or liver transplants from getting sick if they come into contact with SARS-COV-2, which causes COVID-19; also known as coronavirus.

Trial ID: NCT04860297

Trial Details

Researchers in the COVE Transplant Study are trying to find solutions to the COVID-19 pandemic that can help everyone – including those who have received a kidney or liver transplant.

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.

Unvaccinated solid organ transplant participants will have the option to receive a third dose of the COVID-19 vaccine. Vaccinated solid organ transplant participants will receive a third dose of the COVID-19 vaccine.

Estimated Enrollment

220 Participants

Phase

3b

Eligibility Criteria

Participants must:
  • Be at least 18 years old
  • Have received either a kidney transplant or a liver transplant at least six months before screening period
  • Have received chronic immunosuppressive therapy for the prevention of organ rejection for a minimum of 3 months
  • Be unvaccinated OR vaccinated with Moderna’s COVID-19 vaccine under the EUA at least two months prior to consent
Participants must not:
  • Be pregnant or breastfeeding
  • Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within 2 weeks prior to study vaccine administration
  • Be receiving treatment with investigational agents for prevention of COVID-19 or treatment of COVID-19
  • Have participated in another trial in the past month

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We’ll check to see if you are eligible by asking you some questions.

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What to Expect

Participation in the COVE Transplant Study may be up to 15 months and includes up to 10 visits to the study site and 11 phone calls.

Insurance is not needed to join this clinical trial, and compensation for your time will be available.

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Actively Recruiting

  • Omaha, Nebraska, United States
  • Seattle, Washington, United States
  • Atlanta, Georgia, United States
  • Providence, Rhode Island, United States
  • Worcester, Massachusetts, United States
  • New York, New York, United States
  • Mesa, Arizona, United States
  • Tampa, Florida, United States
  • New Haven, Connecticut, United States

Currently Inactive

  • (On hold) Lake Success, New York, United States
  • (Awaiting confirmation) Boston, Massachusetts, United States
  • (Awaiting confirmation) San Diego, California, United States

Frequently Asked Questions (FAQs)

Check Eligibility

We’ll check to see if you are eligible by asking you some questions.

Get Started