Moderna

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 test an experimental 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.

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
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 received or has an appointment to receive a COVID-19 vaccine
  • Have participated in another trial in the past month

Check Eligibility

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

Get Started

What to Expect

Participation in the COVE Transplant Study lasts approximately 13 months and includes approximately seven visits to the study site and nine phone calls.

  • Participants will have two injection visits, which will happen on Day 1 and on Day 29.
  • Participants will be asked to return to the study site seven days after each injection and then two months, seven months, and 13 months after the first injection. During these study site visits, the study team will monitor for COVID-19 symptoms.
  • Participants will be contacted by the study team to monitor for COVID-19 symptoms every four weeks from Day 85 to Day 197, and again from Day 237 to Day 377. During these phone calls, the study team will check how each participant is feeling and ask for updates on their health.
  • Participants will also be asked to complete daily eDiary entries for one week after each injection visit. Participants will be asked to complete monthly eDiary entries from Day 71 to Day 183 and from Day 223 to Day 363.
  • Participants will have their final visit to the study site approximately 12 months after the second injection.

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

  • Seattle, Washington, United States
  • Atlanta, Georgia, United States

Frequently Asked Questions (FAQ)

Check Eligibility

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

Get Started