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

Abstract

Engerix B (GSK HepB, GSK, Belgium) was the first recombinant hepatitis B virus vaccine to be licensed, and marked its 30 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.

Persistence of HBsAg‐specific antibodies and immune memory two to three decades after hepatitis B vaccination in adults

“…In our age‐stratified analyses, the percentage of participants with anti‐HBs levels ≥ 10 mIU/mL and antibody GMCs 20‐30 years after HBsAg vaccination and the anamnestic response to the challenge were in similar ranges for the two age groups (40‐50 and 51‐60 years). This may not be surprising since the maximum age at the first primary dose in the older age group in our study was 35 years and a decrease in the anti‐HBs response to vaccination has been primarily shown for individuals older than 40 years . In addition, anti‐HBs levels in the older age group in our study may have been impacted by the higher proportion of participants in this age group receiving a four‐dose HBsAg vaccination course.…”

“…This may not be surprising since the maximum age at the first primary dose in the older age group in our study was 35 years and a decrease in the anti-HBs response to vaccination has been primarily shown for individuals older than 40 years. 31,32 In addition, anti-HBs levels in the older age group in our study may have been impacted by the higher proportion of participants in this age group receiving a four-dose HBsAg vaccination course. Of note, the time between the last dose of the primary course and the challenge dose was similar for both age groups.…”

Introductory Chapter: Immunization - Vaccine Adjuvant Delivery System and Strategies

“…In particular, as a multifunctional VADS, NPs modified with different materials with intrinsic and specific adjuvanticity, such as TLRas (e.g., MPL and CpG ODN), squalene, and saponin (e.g., water-soluble QS-21), though showing individually distinctive features, share some key characteristics in immune-boosting functions [37]. Summarily, these multifunctional Nps as a VADS trigger immunoresponses with features including, mainly, early activation, though at different levels, of innate immunity, which will subsequently translate into strong antibody and cellular responses to the delivered antigens [5]; a wide breadth of adaptive immunity is able to confer protections against heterovariants of pathogens; for example, vaccines delivered by liposomes containing MPL can defend against influenza viruses or human papillomavirus (HPV) strains that are not contained in the vaccines [38]; significant enhancement of the immunoresponses and the efficacy of vaccines in the elderly who show a waning immune responsiveness to infection and vaccination, as shown for vaccines formulated with MPL-liposomes against herpes zoster virus [39]. These results, together with the feasibility of large-scale manufacture and the track records of acceptable safety profiles of many liposomebased medications, pave the way for developing novel multifunctional liposomes to be used as a VADS for producing the vaccine products fitting humans of different age against infections with a high toll of morbidity and mortality.…”

Retrospective Analysis of Viral Hepatitis B Incidence in Russia from 2013 to 2017 in the Context of Preventive Vaccination

“…Эффективность и безопасность вакцин для профилактики гепатита B подтверждены многочисленными исследованиями [5,[16][17][18]. Результаты метаанализа по заболеваемости вакцинированных лиц свидетельствуют о том, что у лиц, вакцинированных 5-20 лет назад, не выявлены случаи ХГВ, хотя заболеваемость субклинической формой инфекции наблюдалась на уровне 0,7 % [19].…”

“…В настоящее время проводятся многочисленные исследования адъювантных свойств различных соединений. В Европе зарегистрирована рекомбинантная дрожжевая вакцина для профилактики гепатита B с адъювантом AS04 (смесь фосфата алюминия с 3-O-дезацил-4'-монофосфорил липидом А) -Fendrix (ГлаксоСмитКляйн-Бичем) 16 . Новая вакцина предназначена для применения у взрослых людей с диагнозом «почечная недостаточность» (включая пациентов, перенесших гемодиализ и получающих гемодиализ), для которых классическая вакцина (с адъювантом гидроксид алюминия) является слабоиммуногенной.…”