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

ABSTRACT

Introduction: Engerix B (GSK HepB, GSK, Belgium) was the first recombinant hepatitis B virus vaccine to be licensed, and marked its 30^th anniversary in 2016. Vaccination of adult populations against HBV is usually implemented on a risk-based approach with varying degrees of success. Confirmation of ongoing vaccine effectiveness requires monitoring the performance of HBV immunization as reported in individual studies, using systematic methods.

Areas covered: We conducted a systematic review of the literature to summarize 30 years of immunogenicity and safety data for GSK HepB in adult populations.

Expert commentary: Primary 3-dose vaccination of healthy individuals is generally associated with seroprotection rates of 90% or more, although seroprotection decreases with older age. Accelerated 0, 1, 2-month or 0, 7 and 21-day schedules require the recommended booster dose to achieve similar rates of seroprotection. Lower rates of seroprotection were also observed in adults with underlying chronic disease and with a weakened immune system. GSK HepB had a clinically acceptable safety profile in all of the populations studied, including individuals with underlying co-morbidities and immunosuppression. GSK HepB will continue to contribute to global HBV control for the foreseeable future. Further investigation is needed into how to optimize seroprotection in less immune-competent groups.

KEYWORDS:

• Adults
• hepatitis B
• immunocompromised
• immunogenicity
• seroprotection
• vaccines

Acknowledgments

The authors thank Syedah Maria Bokhari who originally conceived the idea for the manuscript, Joanne Wolter (medical writer on behalf of GSK), and Susana Montenegro Gouveia (from XPE Pharma & Science on behalf of GSK) for coordinating the publication development.

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.

Trademarks

Engerix-B and Havrix are trademarks of the GSK groups of companies.

Supplemental data

Supplemental data for this article can be accessed here.

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.