Ohad Etzion1, Victor Novack2, Yael Perl2, Olga Abel2, Doron Schwartz3, Daniella Munteanu3, Naim Abufreha3, Gil Ben-Yaakov3, Eyal D Maoz2, Alex Moshaklo3, Vitaly Dizingf3, Alex Fich3. 1. 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. 2. Clinical Research Center, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel. 3. Department of Gastroenterology and Hepatology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer Sheva, Israel.
Abstract
BACKGROUND AND AIMS: 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. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation (ECCO) 2016. This work is written by US Government employee and is in the public domain in the US.
RCT Entities:
BACKGROUND AND AIMS: 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. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation (ECCO) 2016. This work is written by US Government employee and is in the public domain in the US.
Entities:
Keywords:
Hepatitis B virus vaccine; immunosuppression; inflammatory bowel disease
Authors: Gil Y Melmed; Andrew F Ippoliti; Konstantinos A Papadakis; Tram T Tran; Jaime L Birt; Susie K Lee; Robert W Frenck; Stephan R Targan; Eric A Vasiliauskas Journal: Am J Gastroenterol Date: 2006-06-30 Impact factor: 10.864