Hegde Yash, Lazarus Sarah K, Farraye Francis A, Hollnagel Fauzia, Hayney Mary S, Caldera Freddy
Department of Medicine.
Department of Medicine, Hennepin Healthcare, Minneapolis, MN.
J Clin Gastroenterol. 2025 Sep 1;59(8):773-779. doi: 10.1097/MCG.0000000000002098.
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.
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.
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.
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.
炎症性肠病（IBD）患者通常接受免疫抑制治疗，这会增加包括乙型肝炎（HepB）病毒在内的感染风险。成年IBD患者接种3剂重组HepB疫苗后的血清保护率不理想。Heplisav-B是一种含佐剂的2剂HepB疫苗系列，在一般成年人群中免疫原性更强。在此，我们评估了Heplisav-B在成年IBD患者中的免疫原性。
我们对未对HepB病毒产生血清保护的成年IBD患者进行了一项前瞻性观察性研究，这些患者接受了Heplisav-B疫苗系列接种，并在接种后进行了HepB表面抗体（抗-HBs）血清学检测。接种后抗-HBs≥10 IU/mL被视为血清保护。主要结局是血清保护率。次要结局是不同年龄组、接受免疫抑制治疗的患者以及既往HepB疫苗无应答者的血清保护率，采用单因素分析。
85例患者符合纳入标准，大多数（72%）实现了血清保护，抗-HBs水平中位数为48.7 IU/mL，28例患者（33%）抗-HBs水平>100 IU/mL。接受免疫抑制治疗的患者[49例（58%），18例无应答者，比值比：0.34，95%置信区间：0.12-0.99]和既往HepB疫苗系列的原发性无应答者[22例（26%），11例无应答者，比值比：0.26，95%置信区间：0.09-0.73]实现血清保护的可能性较小。7例无应答患者接受了第三剂Heplisav-B，其中2例实现了血清保护。
在IBD患者中，Heplisav-B的血清保护率高于3剂重组HepB疫苗所见，可能是首选方案。
