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Observational Study
. 2025 Sep 1;59(8):773-779.
doi: 10.1097/MCG.0000000000002098.

High Rate of Seroprotection With Heplisav-B in Patients With Inflammatory Bowel Disease

Yash Hegde  1 , Sarah K Lazarus  2 , Francis A Farraye  3 , Fauzia Hollnagel  4 , Mary S Hayney  5 , Freddy Caldera  6
Affiliations
Observational Study

High Rate of Seroprotection With Heplisav-B in Patients With Inflammatory Bowel Disease

Yash Hegde et al. J Clin Gastroenterol. .

Abstract

Objective: Patients with inflammatory bowel disease (IBD) are commonly treated with immunosuppressive therapies that increase the risk for infections, including hepatitis B (HepB) virus. Adult patients with IBD have suboptimal seroprotection rates after vaccination with a 3-dose recombinant recombinant HepB vaccine. Heplisav-B is an adjuvanted 2-dose HepB series that is more immunogenic in the general adult population. Herein, we evaluated the immunogenicity of Heplisav-B in adult patients with IBD.

Patients and methods: We conducted a prospective observational study of adult patients with IBD who were not seroprotected to HepB virus and received a Heplisav-B series with postimmunization HepB surface antibody (anti-HBs) serologic testing. Postimmunization anti-HBs ≥10 IU/mL was considered seroprotection. The primary outcome was the rate of seroprotection. Secondary outcomes were rates of seroprotection in different age groups, those on immunosuppressive therapy, and previous HepB vaccine nonresponders using a univariate analysis.

Results: Eighty-five patients met the inclusion criteria with the majority (72%) achieving seroprotection with a median anti-HBs level of 48.7 IU/mL and 28 patients (33%) having an anti-HBs level >100 IU/mL. Those on immunosuppressive therapy [49 (58%), 18 nonresponders, odds ratio: 0.34, 95% CI: 0.12-0.99] and primary nonresponders to a previous HepB series [22 (26%), 11 nonresponders, odds ratio: 0.26, 95% CI: 0.09-0.73] were less likely to achieve seroprotection. Seven patients who did not respond received a third dose of Heplisav-B, and 2 achieved seroprotection.

Conclusions: Heplisav-B achieved higher rates of seroprotection than those seen with 3-dose recombinant HepB vaccines in patients with IBD and may be the preferred option.

Keywords: Heplisav-B; hepatitis B virus; inflammatory bowel disease.

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Conflict of interest statement

F.C. has received research support from GSK, Takeda Pharmaceuticals, Janssen and Novavax. He has been a consultant for Takeda, Arena Pharmaceuticals, GSK, and Celgene. F.A.F. is a consultant for AbbVie, Avalo Therapeutics, Bausch, BMS, Braintree Labs, Fresenius Kabi, GI Reviewers, GSK, Iterative Health, Janssen, Pfizer, Sandoz Immunology, Sebela and Viatris. He sits on a DSMB for Lilly Pharmaceuticals. M.S.H. is a consultant for GSK Vaccines and Seqirus and has received research support from Takeda Pharmaceuticals and Dynavax. The remaining authors declare that they have nothing to disclose.

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