Clinical Trials

Overview

About this study

In this study, we will examine the potential side effects experienced after receiving the new hepatitis B vaccine (Heplisav-B) in patients with ulcerative colitis or Crohn's disease. This new vaccine has been found to be more effective than the existing vaccine Engerix in people without ulcerative colitis or Crohn's disease. It is now the standard of practice vaccine that we use in the Mayo gastroenterology and liver practice. The most common side effects include pain, redness, swelling, fatigue, fever and headache. We would also like to determine if there was any worsening of the patient's underlying inflammatory bowel disease.

Part 1

Given these findings and recommendations, members of the Gastroenterology and Infectious Disease department feel that the Heplisav-B vaccine should be the preferred vaccine for patients with IBD and chronic liver disease. In this study, we aim to collect data on patients who receive this vaccine on whether they experience any adverse effects or any worsening of their bowel or liver disease. We also aim to collect data regarding the effectiveness of vaccination by measuring post-vaccination antibody titers at 1 month after vaccination. The goal of this is to confirm that patients have achieved immunity after vaccination. This is consistent with best-practice guidelines and CDC recommendations in immunosuppressed persons.

Part 2:

According to the 2022 Center for CDC guidelines for Hepatitis B vaccination in immunocompromised adults, persons found to have antibody titer concentration <10 mIU/ml (indicating non-immunity) after completion of a primary vaccine series should be revaccinated [6]. Accordingly, in the case of non-immunity after the standard 2-dose Heplisav-B series, we aim to give an additional dose of Heplisav-B and re-measure antibody titers at 1 month in order to evaluate effectiveness. This is consistent with best-practice and CDC guidelines in immunosuppressed patients that have not responded to the primary vaccination series. To this point, the CDC guidelines for Hepatitis B vaccination in immunocompromised adults state that a larger vaccine dose or additional vaccine doses may be necessary in this patient population [6]. Immunity to Hepatitis B through vaccination in patients with inflammatory bowel disease and chronic liver disease is crucial due to high risk of morbidity.

Part 3:

As a continuation of the above, we aim to perform immunological testing to observing T cell response to Heplisav-B vaccination. The goal is to measure if there are any differences in T cell response depending on certain immunosuppressive medications that the patient is taking for their IBD.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Participating Mayo Clinic locations

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