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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.

Currently, we are enrolling for Part B of the Cove Transplant study. In Part B, currently enrolled participants and eligible participants (please see eligibility criteria below) who received the primary COVID-19 vaccination series (i.e. Pfizer, Moderna, Janssen/J&J) outside of the study will be offered a booster dose of the Moderna COVID-19 vaccine.

Estimated Enrollment

240 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 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
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
  • 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 Part B may be up to 6 months and includes up to 5 visits to the study site and 6 phone calls.

  • All eligible participants in Part A who are at least 4 months from their last dose will be offered a booster dose and have one injection visit on Day 1.
  • Solid organ transplant recipients who completed a primary COVID-19 vaccination series outside of the study will receive a booster dose and have one injection on Day 1.
  • Participants will be asked to return to the study site three and seven days after the injection and then one month and 6 months after the injection.
  • Participants will be contacted by the study team to monitor for COVID-19 symptoms. 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 the injection visit.

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 the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

Check Eligibility

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

Get Started