Safety and efficacy of the mRNA-1273 SARS-CoV-2 vaccine in a cohort of patients with inflammatory bowel disease

Background The Covid-19 pandemic has evolved a global burden that catalyzed the rapid development of new mRNA vaccines. In general population studies show that the effectiveness of the mRNA-1273 SARS-CoV-2 vaccine is 94,1 %. There is insufficient data about the SARS-CoV-2 mRNA-1273 vaccine in patients with inflammatory bowel disease (IBD) with and without immunosuppressive therapy.

Methods In this single-center prospective cohort-analysis we investigate the immune response to the mRNA-1273 SARS-CoV-2 vaccine in a cohort of patients with IBD with or without immunomodulatory therapy. Patients received two vaccinations that were organized in house at our clinic at baseline and day 28. We obtained blood samples at baseline, day 28 and day 56. The vaccination offer was received very well by our patients. We measured antibody levels against the surface spike protein and the nucleocapsid of SARS-CoV-2. Furthermore we performed interferon-gamma-release-assays for the spike and nucleocapsid proteins and a virus-neutralisation test. Side effects were observed on day 28 and day 56 with the questionnaire of the Austrian ministry of health.

Results In total, we included 64 patients from the Kepler University hospital in our study, 36 patients with IBD and 28 healthy controls. Regarding the immunomodulatory treatment, the cohorts comprised 8 patients on adalimumab, 9 on infliximab, 6 on vedolizumab, 6 on ustekinumab and 7 on mesalazine therapy. To this point we just have preliminary data of the blood samples at baseline and day 28. The increase of antibody levels was significant in all cohorts with no significant difference throughout the cohorts. Moderate side effects like fever or muscle pain were observed equally in our cohorts. No severe side effect occurred.

Conclusion The mRNA-1273 SARS-CoV-2 vaccine seems to be safe and effective in patients with IBD and immunomodulatory treatment regimens but there is a need for more high-quality data on this topic.

Publication History

Article published online:
01 September 2021