Adverse effects related to Heplisav-B vaccination in patients with Inflammatory Bowel Disease


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.

We also aim to perform immunological testing observing T cell response to Heplisav 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.

Inclusion Criteria:

  • Adults (>18 years in age).
  •  Diagnosed with inflammatory bowel disease and who receive the Heplisav-b vaccine.

Exclusion Criteria: 

  • Patients age < 18 years old.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Francis Farraye, M.D., M.S.

Contact us for the latest status

Contact information:

Nader Daoud M.B.B.S.

(904) 953-6970

More information


Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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