Efficacy of Hepatitis B Vaccination with a Novel Immunostimulatory Sequence Adjuvant (Heplisav-B) in Patients With Inflammatory Bowel Disease.

Background: Owing to the use of immunosuppressive agents, patients with inflammatory bowel disease (IBD) have an increased risk of vaccine preventable diseases, including infection with hepatitis B virus (HBV). Heplisav-B, an FDA-approved vaccine, is more effective (90% to 100%) than Engerix-B (70.5% to 90.2%) at inducing immunity to HBV in clinical studies. Available data on efficacy of Heplisav-B vaccine in patients with IBD are limited.

Methods: This retrospective observational study included patients age 18 years and older with ulcerative colitis (UC) or Crohn's disease (CD) who received 1 or 2 doses of Heplisav-B vaccine and had postvaccination serologic testing. Prior to immunization, all participants were seronegative for HBsAb antibodies (HBsAb) measured as <10 IU/mL. Postvaccination HBsAb of ≥10 IU/mL was considered successful vaccination. Patient demographics, disease characteristics, and medications were abstracted.

Results: One hundred six patients were included in the analysis. Median age was 43 years, and 44 (42%) were female. Thirty-nine patients (37%) had UC, whereas 67 (63%) had CD. Eighty-three patients (78.3%) had active immunity after vaccination with Heplisav-B, with median postvaccination HBsAb levels of 114 IU/L. Patients with chronic obstructive pulmonary disease, chronic kidney disease, diabetes mellitus, immunomodulator use, or those on 2 or more of immunosuppressive medications were less likely to respond to Heplisav-B, though these findings were not statistically significant on a multivariate analysis aside from chronic kidney disease.

Conclusions: Heplisav-B, a 2-dose vaccine, is an effective vaccine for HBV in patients with IBD. In our study, its overall efficacy (78.3%) is greater than that reported for the presently available 3-dose vaccination (Engerix) in patients with IBD.