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

ABSTRACT

Introduction: 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. Engerix™ B (GSK HepB, GSK, Belgium) was the first recombinant HBV vaccine to be licensed, and marked its 30th anniversary in 2016.

Areas covered: We conducted a systematic review of the literature summarizing 30 years of immunogenicity and safety data for GSK HepB in children and adolescents.

Expert commentary: 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. GSK HepB 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. GSK HepB will continue to contribute to global HBV control for the foreseeable future.

KEYWORDS:

• Hepatitis B
• vaccines
• hepatitis B surface antigen
• efficacy
• immunogenicity
• seroprotection
• immunocompromised
• children

Declaration of interest

E.M Bunge and C.VD Ende and A.V Ahee are employees of Pallas, a commercial entity that has received grants from the GSK Group of Companies and which carried out part of the submitted work as a supplier to GSK Vaccines. C Marano and L. D Moerlooze are employees of the GSK group of companies and hold stock options/restricted shares from the sponsoring company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed

Supplemental data

Supplemental data for this article can be accessed here.

Trademarks

Engerix is a trademark of the GSK groups of companies.

Additional information

Funding

This systematic review was sponsored and funded by GlaxoSmithKline Biologicals S.A, Belgium. GlaxoSmithKline Biologicals S.A was involved in all stages of the study conduct and analysis; and also took charge of all costs associated with the development and the publishing of the manuscript.