What is the purpose of this study?
The purpose of this study is to examine levels of SARS-CoV-2 antibodies in patients with chronic medical conditions who receive the SARS-CoV-2 vaccine. This knowledge will lead to a better understanding of antibody response and durability in patients with chronic medical conditions who receive the 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. If participants 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 post-vaccination to determine antibody levels.
Why should I refer my patients to participate in your study?
Patients with certain chronic conditions have traditionally been excluded from vaccine trials. Little is known about durable immunity in these patient populations following vaccination. This study can inform public health recommendations for your patients.
The study acknowledges that antibody serologic testing does not imply protection; however, the information will likely still be helpful in understanding the landscape of responses in this population.
What does the study involve?
This study will involve the completion of a survey and blood sample collection through the patient’s local LabCorp. Blood will be collected at 6 time points: pre-vaccination, between the two doses if the participant receives a 2 dose vaccine, and at 1, 3, 6, and 12 months after vaccination for SARS-CoV-2 antibody testing. There is no cost to participants. No in-person study visits are required.
What data are being collected?
The survey includes questions on demographics, general health, comorbidities, and prior COVID-19 diagnosis. Information on the LabCorp test can be found here.
Some of my patients have received convalescent plasma, Regeneron, or some other “antibody-based” therapy for COVID-19. Are they eligible to participate?
Yes
Some of my patients have had COVID-19 infection. Are they eligible to participate?
Yes
How do I inform my patients about the study?
Please ask your patients to visit this website. Once on the site, they can fill out an online form, which will determine whether they are eligible to participate. If eligible, they will be contacted by our study team with further instructions on how to complete the sample collection. Eligibility criteria are: 18+, English-speaking, living in the US, intention to be vaccinated, 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.
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
COVID-19 Vaccination in Patients with Chronic Conditions