K Van Herck1, G Leroux-Roels, P Van Damme, K Srinivasa, B Hoet. 1. Centre for the Evaluation of Vaccination, WHO Collaborating Centre for Prevention and Control of Viral Hepatitis, Unit of Epidemiology and Social Medicine, University of Antwerp - Campus Drie Eiken, Wilrijk, Belgium. koen.vanherck@ua.ac.be
Abstract
BACKGROUND: Hepatitis A and B infections are prevalent worldwide and cause significant morbidity and mortality. A combined vaccine providing dual protection against hepatitis A and B is available (Twinrix, GlaxoSmithKline Biologicals). METHOD:Two cohorts of adults aged 17-43 years were vaccinated with Twinrix according to a 0, 1, 6 months schedule and followed up for 10 years. RESULTS: One month after the primary vaccination course (Month 7), all subjects were seropositive for anti-HAV and all had anti-HBs> or = 10 mIU/ml. At month 120, 100% of subjects (N=34; N=29) in both cohorts were seropositive for anti-HAV; 94.1% and 86.2% of subjects had anti-HBs > or = 10 mIU/ml. The geometric mean concentrations (GMC; mIU/ml) were 373.9 and 674.6 in the two cohorts for anti-HAV, and 103.8 and 320.0, respectively, for anti-HBs. None of the serious adverse events reported throughout the follow-up period were considered by the investigator to be causally related to vaccination. CONCLUSIONS: Combined hepatitis A and B vaccine, Twinrix, is safe, well-tolerated and has demonstrated a highly immunogenic profile. Persistence of anti-HAV and anti-HBs antibodies in adults remains high for at least 10 years after primary vaccination.
RCT Entities:
BACKGROUND:Hepatitis A and B infections are prevalent worldwide and cause significant morbidity and mortality. A combined vaccine providing dual protection against hepatitis A and B is available (Twinrix, GlaxoSmithKline Biologicals). METHOD: Two cohorts of adults aged 17-43 years were vaccinated with Twinrix according to a 0, 1, 6 months schedule and followed up for 10 years. RESULTS: One month after the primary vaccination course (Month 7), all subjects were seropositive for anti-HAV and all had anti-HBs> or = 10 mIU/ml. At month 120, 100% of subjects (N=34; N=29) in both cohorts were seropositive for anti-HAV; 94.1% and 86.2% of subjects had anti-HBs > or = 10 mIU/ml. The geometric mean concentrations (GMC; mIU/ml) were 373.9 and 674.6 in the two cohorts for anti-HAV, and 103.8 and 320.0, respectively, for anti-HBs. None of the serious adverse events reported throughout the follow-up period were considered by the investigator to be causally related to vaccination. CONCLUSIONS: Combined hepatitis A and B vaccine, Twinrix, is safe, well-tolerated and has demonstrated a highly immunogenic profile. Persistence of anti-HAV and anti-HBs antibodies in adults remains high for at least 10 years after primary vaccination.
Authors: Pierre Van Damme; Geert Leroux-Roels; P Suryakiran; Nicolas Folschweiller; Olivier Van Der Meeren Journal: Hum Vaccin Immunother Date: 2017-03-10 Impact factor: 3.452