The immunogenicity of GSK’s recombinant hepatitis B vaccine in children: a systematic review of 30 years of experience

Abstract

<p><b>Introduction</b>: The World Health Organization recommends hepatitis B virus (HBV) vaccines to be included in national immunization schedules everywhere, and has adopted the strategic goal of halting viral hepatitis as a major public health threat by 2030, under which vaccination plays a major role. <i>Engerix</i>™ B (<i>GSK HepB</i>, GSK, Belgium) was the first recombinant HBV vaccine to be licensed, and marked its 30th anniversary in 2016.</p> <p><b>Areas covered</b>: We conducted a systematic review of the literature summarizing 30 years of immunogenicity and safety data for <i>GSK HepB</i> in children and adolescents.</p> <p><b>Expert commentary</b>: Primary 3-dose vaccination of healthy infants and children, including infants born to HBsAg-positive mothers, using the standard 0, 1, 6 month schedule was associated with seroprotection rates ≥96.0%. In high-risk infants, vaccine efficacy at year 5 was 96.0% after 3-dose priming in infancy and immunoglobulin at birth. Lower seroprotection rates were observed in children with severe underlying disease including human immunodeficiency virus infection and cancer. <i>GSK HepB</i> had a clinically acceptable safety profile in all of the populations studied. HBV vaccines have demonstrated long-term impacts on rates of fulminant hepatitis, chronic liver disease and hepatocellular carcinoma. <i>GSK HepB</i> will continue to contribute to global HBV control for the foreseeable future.</p