title: Sci-B-VacTM Vs ENGERIX-B Vaccines for Hepatitis B Virus in Patients with Inflammatory Bowel Diseases: A Randomised Controlled Trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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].
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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 ohad.etzion@nih.gov.
authors.forename: Ohad
authors.initials: O
authors.lastname: Etzion
authors.affiliation: Clinical Research Center, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Victor
authors.initials: V
authors.lastname: Novack
authors.affiliation: Clinical Research Center, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Yael
authors.initials: Y
authors.lastname: Perl
authors.affiliation: Clinical Research Center, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Olga
authors.initials: O
authors.lastname: Abel
authors.affiliation: Department of Gastroenterology and Hepatology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Doron
authors.initials: D
authors.lastname: Schwartz
authors.affiliation: Department of Gastroenterology and Hepatology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Daniella
authors.initials: D
authors.lastname: Munteanu
authors.affiliation: Department of Gastroenterology and Hepatology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Naim
authors.initials: N
authors.lastname: Abufreha
authors.affiliation: Department of Gastroenterology and Hepatology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Gil
authors.initials: G
authors.lastname: Ben-Yaakov
authors.affiliation: Clinical Research Center, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Eyal D
authors.initials: ED
authors.lastname: Maoz
authors.affiliation: Department of Gastroenterology and Hepatology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Alex
authors.initials: A
authors.lastname: Moshaklo
authors.affiliation: Department of Gastroenterology and Hepatology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Vitaly
authors.initials: V
authors.lastname: Dizingf
authors.affiliation: Department of Gastroenterology and Hepatology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Alex
authors.initials: A
authors.lastname: Fich
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D036022:Capsid Proteins / Q000008:administration & dosage / Q000276:immunology*; D005260:Female; D006509:Hepatitis B / Q000150:complications / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015212:Inflammatory Bowel Diseases / Q000097:blood / Q000150:complications* / Q000188:drug therapy / Q000276:immunology; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D000069078:Seroconversion; D016037:Single-Blind Method; D055815:Young Adult
chemical_list: D015415:Biomarkers; D036022:Capsid Proteins; C075654:Engerix-B; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D007166:Immunosuppressive Agents; C000608755:Pre-S vaccine
keywords: Hepatitis B virus vaccine; immunosuppression; inflammatory bowel disease