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What is the purpose of this study?
The purpose of this study is to examine levels of COVID-19 antibodies in patients with certain chronic conditions before and after they get the COVID-19 vaccine. This knowledge will lead to a better understanding of how effectively the vaccine can help these patients get immunity.
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. If you will be receiving a vaccine and are interested in the study, we will collect a sample before vaccination and collect samples at sequential time points after vaccination to determine antibody levels.
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?
18+ years old, English-speaking, living in the US, received a COVID-19 vaccine or intention to receive a COVID-19 vaccine, and a chronic medical condition including: cirrhosis, end-stage renal disease using home dialysis, HIV, inflammatory bowel disease (Crohn’s disease or ulcerative colitis), an autoimmune/immune-mediated condition, Parkinson’s disease, or Alzheimer’s disease.
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 patients with certain chronic conditions?
Patients with certain chronic conditions may be less likely to mount a durable immune response due to the medications and treatments they are on or the condition itself. Additionally, patients with certain chronic conditions are often prevented from participating in vaccine trials. We hope to bridge this knowledge gap to better understand the COVID-19 vaccine in patients with chronic conditions.
Dorry Segev, MD, PhD | Jacqueline Garonzik-Wang, MD, PhD | | Julie Paik, MD | Lisa Christopher-Stine, MD | Robin Avery, MD | Douglas Mogul, MD, PhD | William Werbel, MD | Brian Boyarsky, MD | Caoilfhionn Connolly, MD
Copyright Johns Hopkins University, 2020 | Baltimore, MD 21205