CORALE - IBD
Inflammatory bowel disease, COVID-19
Key Inclusion Criteria:
- Participants for whom vaccines are authorized for ages 13 and over with inflammatory bowel disease (IBD)
- History of chronic (more than 1 month) ulcerative colitis or Crohn’s disease
- Planned or prior receipt of any authorized vaccine against COVID-19
Key Exclusion Criteria:
- Receipt of initial vaccine against COVID-19 more than 1 year prior to enrollment
Full Study Name
The Coronavirus Risk Associations and Longitudinal Evaluation (CORALE) Study (IRB no. 00001411)
This study focuses on individuals who are at least 13 years old and have inflammatory bowel disease (Crohn’s disease or ulcerative colitis). The purpose of the study is to understand the effects of COVID-19 vaccination in these patients. Specifically, researchers want to learn more about the duration and quality of immunity after vaccination and clarify any risks or side effects associated with vaccination in people with IBD. The study also aims to determine whether IBD medications affect the effectiveness or safety of these vaccines.
Researchers will collect social, demographic, clinical, lifestyle/environmental, molecular, and other data from participants. Samples will be analyzed for molecular markers of susceptibility, as well as resistance to infection and disease.