Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
Gastroenterology Unit, Hospital Santa Creu i Sant Pau, Barcelona, Spain.
Am J Gastroenterol. 2020 Nov;115(11):1802-1811. doi: 10.14309/ajg.0000000000000926.
To compare Engerix-B and Fendrix hepatitis B virus for primo vaccination in inflammatory bowel disease (IBD).
Patients with IBD were randomized 1:1 to receive Engerix-B double dose or Fendrix single dose at months 0, 1, 2, and 6. Anti-HBs titers were measured 2 months after the third and fourth doses. Response to vaccination was defined as anti-HBs ≥100 UI/L. Anti-HBs titers were measured 2 months after the third and fourth doses and again at 6 and 12 months after the fourth dose.
A total of 173 patients were randomized (54% received Engerix-B and 46% Fendrix). Overall, 45% of patients responded (anti-HBs ≥100 IU/L) after 3 doses and 71% after the fourth dose. The response rate after the fourth dose was 75% with Fendrix vs 68% with Engerix-B (P = 0.3). Older age and treatment with steroids, immunomodulators, or anti-tumor necrosis factor were associated with a lower probability of response. However, the type of vaccine was not associated with the response. Anti-HBs titer negativization occurred in 13% of patients after 6 months and 20% after 12 months. Anti-HBs ≥100 IU/L after vaccination was the only factor associated with maintaining anti-HBs titers during follow-up.
We could not demonstrate a higher response rate of Fendrix (single dose) over Engerix-B (double dose). A 4-dose schedule is more effective than a 3-dose regimen. Older age and treatment with immunomodulators or anti-tumor necrosis factors impaired the success. A high proportion of IBD patients with protective anti-HBs titers after vaccination loose them over time. The risk of losing protective anti-HBs titers is increased in patients achieving anti-HBs <100 IU/L after the vaccination.
比较 Engerix-B 和 Fendrix 乙型肝炎病毒在炎症性肠病（IBD）患者中的 primo 疫苗接种效果。
将 IBD 患者随机分为 1:1 组，分别接受 Engerix-B 双倍剂量或 Fendrix 单剂量，在 0、1、2 和 6 个月时接种。在第三和第四剂后 2 个月测量抗-HBs 滴度。将抗-HBs≥100 UI/L 定义为疫苗接种反应。在第三和第四剂后 2 个月以及第四剂后 6 和 12 个月测量抗-HBs 滴度。
共纳入 173 例患者（54%接受 Engerix-B，46%接受 Fendrix）。总体而言，3 剂后有 45%（抗-HBs≥100 IU/L）的患者有反应，4 剂后有 71%的患者有反应。第四剂后，Fendrix 的反应率为 75%，Engerix-B 为 68%（P=0.3）。年龄较大、接受皮质类固醇、免疫调节剂或抗肿瘤坏死因子治疗与反应概率降低相关。然而，疫苗类型与反应无关。6 个月后有 13%的患者出现抗-HBs 滴度阴性化，12 个月后有 20%的患者出现抗-HBs 滴度阴性化。接种疫苗后抗-HBs≥100 IU/L是随访期间维持抗-HBs 滴度的唯一因素。
我们未能证明 Fendrix（单剂量）的反应率高于 Engerix-B（双剂量）。四剂方案比三剂方案更有效。年龄较大以及接受免疫调节剂或抗肿瘤坏死因子治疗会降低成功率。接种疫苗后，大量 IBD 患者获得保护性抗-HBs 滴度，但随着时间的推移会失去这些滴度。接种疫苗后抗-HBs<100 IU/L的患者失去保护性抗-HBs 滴度的风险增加。
