Etzion Ohad, Novack Victor, Perl Yael, Abel Olga, Schwartz Doron, Munteanu Daniella, Abufreha Naim, Ben-Yaakov Gil, Maoz Eyal D, Moshaklo Alex, Dizingf Vitaly, Fich Alex
Liver Disease Branch, NIDDK, NIH, Bethesda, USA Department of Gastroenterology and Hepatology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel
Clinical Research Center, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
J Crohns Colitis. 2016 Aug;10(8):905-12. doi: 10.1093/ecco-jcc/jjw046. Epub 2016 Feb 29.
Response rate to second-generation hepatitis B virus vaccines is relatively low in patients with inflammatory bowel diseases compared with the general healthy population. We compared the efficacy and safety of a third- vs a second-generation hepatitis B virus vaccine in a group of patients with inflammatory bowel diseases treated with immunosuppressive medications.
Prospective, randomised, single-blind, controlled study. Eligible patients were randomly assigned to receive one of two vaccines, ENGERIX-B or Sci-B-Vac. The vaccines were administered in three doses at 0, 1, and 6 months. The primary endpoint was defined as the titre of anti-hepatitis B S [HBs] antibodies following the standard three-dose hepatitis B virus vaccination schedule.
A total of 72 patients complied with study protocol [37 and 35 patients in the ENGERIX-B and Sci-B-Vac groups, respectively]. Overall, 75% of the cohort seroconverted. The primary endpoint was met in 81.1% in the ENGERIX-B group and 68.6% in the Sci-B-Vac group [p = 0.22]. Patients in the Sci-B-Vac group showed a statistically significant decreased seroconversion rate compared with the ENGERIX-B group, with use of tumour necrosis factor [TNF] alpha inhibitors [p = 0.03], and higher degree of disease activity [p = 0.03].
Overall seroconversion rate in our cohort was higher than in previous reports in the literature, possibly due to a low disease activity state in the majority of participants. Third-generation hepatitis B virus vaccines showed no apparent advantage over standard of care vaccine in this patient group.
与一般健康人群相比，炎症性肠病患者对第二代乙肝疫苗的应答率相对较低。我们比较了第三代与第二代乙肝疫苗在一组接受免疫抑制药物治疗的炎症性肠病患者中的疗效和安全性。
前瞻性、随机、单盲、对照研究。符合条件的患者被随机分配接受两种疫苗之一，即安在时（ENGERIX - B）或希必维（Sci - B - Vac）。疫苗按0、1和6个月分三次接种。主要终点定义为按照标准的三剂次乙肝疫苗接种程序接种后抗乙肝表面抗原（HBs）抗体的滴度。
共有72例患者遵守研究方案（安在时组和希必维组分别为37例和35例）。总体而言，该队列中75%的患者发生了血清转化。安在时组81.1%的患者达到主要终点，希必维组为68.6%（p = 0.22）。希必维组患者与安在时组相比，使用肿瘤坏死因子（TNF）α抑制剂时血清转化率有统计学显著下降（p = 0.03），且疾病活动度较高时也有下降（p = 0.03）。
我们队列中的总体血清转化率高于文献中先前的报道，这可能是由于大多数参与者的疾病活动状态较低。在该患者组中，第三代乙肝疫苗相对于标准护理疫苗未显示出明显优势。
