National Foundation for Infectious Diseases

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

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

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

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.

In order to participate, you will need to go to one of the study clinics taking part in this clinical trial. Study clinics are located in:

Frequently Asked Questions (FAQs)

What is a clinical research study?

Clinical research studies include scientifically evaluated plans, or protocols, that outline how to test if a potential new medication or vaccine is safe and/or effective in people. All investigational medications and vaccines must be tested in clinical research studies before they can be submitted for approval by regulatory authorities. A clinical research study is conducted by doctors and researchers who follow strict guidelines to ensure the safety and wellbeing of the study volunteers who participate. Although side effects can occur in any clinical trial, the study is designed to minimize the risk and you will be monitored closely.

What are the phases of clinical research?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase 1 trials, researchers test a new vaccine, drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the study vaccine, drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the study vaccine, drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

Reference: https://www.ciscrp.org/education-center/important-information/#faq

Why is diversity important in clinical trials?

Clinical research studies and study volunteers are vital to creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.

Given that certain populations and ages can respond differently to medical therapies, it is extremely important that this clinical research study include people of all ages, genders, races and ethnicities to ensure the vaccine is safe and effective for everyone to use.

Will compensation for time be available as part of this clinical trial?

Yes, reimbursement for travel will be available. We realize it takes time to come for study visits, so we want to make sure this is not too much of a burden for you. The study site will review these details with you.

Does the mRNA-1273 study vaccine contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1273 study vaccine is different. It is made from an instructional molecule called mRNA that tells your cells how to make protein. In this case, the protein is a small part of the virus that is thought to help the body’s immune system protect itself if you ever come in contact with the coronavirus.

What happens if I am diagnosed with COVID-19 while in this trial?

You will be closely monitored by the study doctor and medical staff for symptoms of COVID-19 while in the COVE Transplant Study. If you are diagnosed with COVID-19 during the trial, the study team will notify your primary care physician and the study team will continue to monitor your well-being closely.

Can I get COVID-19 from the study vaccine being researched?

You cannot get infected with SARS-CoV-2 or get COVID-19 illness from the mRNA-1273 study vaccine.

How can I check to see if I am eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this website by clicking the “Get Started” button.

Can I quit the trial at any time?

You have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the volunteer’s safety, or if the study volunteer no longer meets the study requirements.