Cell-Mediated Immune Response after COVID 19 Vaccination in Patients with Inflammatory Bowel Disease

Introduction Most patients with IBD mount an antibody response to mRNA COVID-19 vaccines, but few studies have evaluated the cell mediated immune response (CMIR). Methods We performed a prospective study (HERCULES) to evaluate CMIR among patients with IBD and healthy controls (HC) after completion of the primary series of mRNA COVID-19 vaccines. Results One hundred 158 patients with IBD and 20 HC were enrolled. The majority (89%) of IBD patients developed a CMIR which was not different than HC (94%, p=0.6667). There was no significant difference (p=0.5488) in CMIR response between those not immunosuppressed (median 255 Spike T cells/million PBMC, IQR 146, 958) and immunosuppressed (median 377, IQR 123, 1440). There was also no correlation between antibody responses and CMIR (p=0.5215) Discussion Most patients with IBD achieved CMIR to a COVID-19 vaccine. Future studies are needed evaluating sustained CMIR and clinical outcomes. ### Competing Interest Statement Potential competing interests: Dr. Freddy Caldera has received research support from Takeda Pharmaceuticals. He has been a consultant for Takeda, Arena Pharmaceuticals, GSK, and Celgene. Dr. Farraye is a consultant for Arena, BMS, Braintree Labs, Gilead, GSK, Innovation Pharmaceuticals, Iterative Scopes, Janssen, Pfizer and Sebela. He sits on a DSMB for Bacainn Pharmaceuticals, Lilly and Theravance. Dr. Hayney is a consultant for GSK Vaccines and Seqirus and has received research support from Takeda Pharmaceuticals, Dynavax, and Sanofi. Dr. Chun is an employee of LabCorp. Dr. Swift has received research support from Pfizer. ### Funding Statement Takeda Pharmaceuticals, American College of Gastroenterology, and the Mayo Clinic. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study received Institutional Review Board approval at the University of Wisconsin and Mayo Clinic Florida I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors