What is the purpose of this study?
The purpose of this study is to examine levels of COVID-19 antibodies in children who are organ transplant candidates or recipients before and after they get the COVID-19 vaccine.
The study does not provide the vaccine, and study team members will not be offering guidance as to whether one should or should not receive the SARS-CoV-2 vaccine.
What is known about immunity to COVID-19?
The immune response, including if you would be protected from getting re-infected (either after getting the infection or the vaccine) is not yet fully understood.
Where can I go for more information about the COVID-19 vaccine?
What does the study involve?
This study will involve the completion of a survey and blood sample collection through your local LabCorp. Blood will be collected at 6 time points: pre-vaccination, between the two doses if you are receiving the Pfizer or Moderna vaccines, and at 1, 3, 6, and 12 months after vaccination for SARS-CoV-2 antibody testing. There is no cost to participating. No in-person study visits are required.
What are the eligibility criteria?
Pediatric (<18 years before you receive the first dose), English-speaking, received a COVID-19 vaccine or intention to receive a COVID-19 vaccine, and one of the following conditions:
- Solid organ transplant recipient (e.g., liver, kidney, heart, or lung)
- Listed for organ transplant
- On dialysis
Can I participate if I had COVID-19 already?
How do I participate?
Fill out an online form (below), which will determine your eligibility. If you are eligible, then you will be contacted by our study team with further instructions on how to complete the survey and the blood collection once you get your vaccine. No in-person study visits are be required.
Will I receive my results?
Yes, when the blood results are available from LabCorp, we will share your results with you.
What are antibodies?
Antibodies are proteins that are part of our immune system whose job it is to eliminate invaders, such as the virus that causes COVID-19.
Who has COVID-19 antibodies?
We expect anyone who has either been infected by or vaccinated for the virus that causes COVID-19 to have antibodies against the virus. However, what is unknown is the level of antibody that is necessary to cause immunity.
Antibody levels do not necessarily imply protection; it is important to continue safety measures (mask wearing, social distancing) even if you develop COVID-19 antibodies.
Could I have COVID-19 antibodies without being infected by the virus?
Yes. In theory, your body creates COVID-19 antibodies after vaccination.
I have received convalescent plasma, Regeneron, or some other “antibody-based” therapy for COVID-19. Can I still participate?
Why are you studying pediatric recipients of solid organ transplants?
Pediatric recipients of solid organ transplants may be less likely to mount a durable immune response due to the medications and treatments they are on. Additionally, pediatric recipients of solid organ transplants are often prevented from participating in vaccine trials. We hope to bridge this knowledge gap to better understand the COVID-19 vaccine
For information about this study if you are less than 18 years old, please e-mail firstname.lastname@example.org.