Engerix-B (Hepatitis B Vaccine (Recombinant)) - Summary

ENGERIX-B SUMMARY

ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a noninfectious recombinant DNA hepatitis B vaccine developed and manufactured by GlaxoSmithKline Biologicals. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The surface antigen expressed in Saccharomyces cerevisiae cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX-B result in a product that contains no more than 5% yeast protein. No substances of human origin are used in its manufacture. ENGERIX-B is supplied as a sterile suspension for intramuscular administration. The vaccine is ready for use without reconstitution; it must be shaken before administration since a fine white deposit with a clear colorless supernatant may form on storage. ENGERIX-B is formulated without preservatives.

ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by ENGERIX-B vaccination.

ENGERIX-B will not prevent hepatitis caused by other agents, such as hepatitis A, C, and E viruses, or other pathogens known to infect the liver.

Immunization is recommended in persons of all ages, especially those who are, or will be, at increased risk of exposure to hepatitis B virus,¹ for example:

• Infants, Including Those Born of HBsAg-Positive Mothers (See DOSAGE AND ADMINISTRATION.)
• Adolescents (See CLINICAL PHARMACOLOGY.)
• Healthcare Personnel: Dentists and oral surgeons. Dental, medical, and nursing students. Physicians, surgeons, and podiatrists. Nurses. Paramedical and ambulance personnel and custodial staff who may be exposed to the virus via blood or other patient specimens. Dental hygienists and dental nurses. Laboratory and blood bank personnel handling blood, blood products, and other patient specimens. Hospital cleaning staff who handle waste.
• Selected Patients and Patient Contacts: Patients and staff in hemodialysis units and hematology/oncology units. Patients requiring frequent and/or large volume blood transfusions or clotting factor concentrates (e.g., persons with hemophilia, thalassemia, sickle cell anemia, cirrhosis). Clients (residents) and staff of institutions for the mentally handicapped. Classroom contacts of deinstitutionalized mentally handicapped persons who have persistent hepatitis B surface antigenemia and who show aggressive behavior. Household and other intimate contacts of persons with persistent hepatitis B surface antigenemia.
• Subpopulations With a Known High Incidence of the Disease, such as: Alaskan Eskimos. Pacific Islanders. Indochinese immigrants. Haitian immigrants. Refugees from other HBV-endemic areas. All infants of women born in areas where the infection is highly endemic.
• Individuals With Chronic Hepatitis C: Risk factors for hepatitis C are similar to those for hepatitis B. Consequently, immunization with hepatitis B vaccine is recommended for individuals with chronic hepatitis C.
• Persons Who May Be Exposed to the Hepatitis B Virus by Travel to High-Risk Areas (See ACIP Guidelines, 1990.)
• Military Personnel Identified as Being at Increased Risk
• Morticians and Embalmers
• Persons at Increased Risk of the Disease Due to Their Sexual Practices,^1,16 such as: Persons with more than 1 sexual partner in a 6-month period. Persons who have contracted a sexually transmitted disease. Homosexually active males. Female prostitutes.
• Prisoners
• Users of Illicit Injectable Drugs
• Others: Police and fire department personnel who render first aid or medical assistance, and any others who, through their work or personal life-style, may be exposed to the hepatitis B virus. Adoptees from countries of high HBV endemicity.

NEWS HIGHLIGHTS

Media Articles Related to Engerix-B (Hepatitis B Vaccine)

Flu Vaccination Rates Among Healthcare Workers Have Plateaued
Source: Medscape Allergy & Clinical Immunology Headlines [2017.09.28]
In addition, vaccination rates in the general US population were disappointingly low last year; they were highest in children aged 6 to 23 months, the CDC said.
Medscape Medical News

Vaccination 101: Make Sure Kids Are Up to Date
Source: MedicineNet Encephalitis and Meningitis Specialty [2017.08.28]
Title: Vaccination 101: Make Sure Kids Are Up to Date
Category: Health News
Created: 8/28/2017 12:00:00 AM
Last Editorial Review: 8/28/2017 12:00:00 AM

Vaccination Schedule for Adults and Adolescents
Source: MedicineNet Tuberculosis Skin Test (PPD Skin Test) Specialty [2016.09.14]
Title: Vaccination Schedule for Adults and Adolescents
Category: Procedures and Tests
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 9/14/2016 12:00:00 AM

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Published Studies Related to Engerix-B (Hepatitis B Vaccine)

Long-term efficacy of a hepatitis E vaccine. [2015]
long-term efficacy of a hepatitis E vaccine needs to be determined... CONCLUSIONS: Immunization with this hepatitis E vaccine induced antibodies

Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. [2011.07]
BACKGROUND: A modified process hepatitis B vaccine (mpHBV) uses higher phosphate content in the manufacturing process relative to the current product, Recombivax-HB. The higher phosphate is thought to improve antigen presentation, and thereby, increase antibody production. The mpHBV was previously shown to be well tolerated and immunogenic in adults. The current study tested a 2-, 4-, 6-month vaccination schedule and a higher dose formulation (10 mug mpHBV) in healthy infants... CONCLUSIONS: All 4 hepatitis B vaccines elicited high anti-HBs SPRs. After dose 3, anti-HBs GMT were highest in the 10 mug mpHBV group, but did not meet the predefined criteria for superiority. All vaccines were well tolerated.

Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. [2011.06]
BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 mug Hansenula polymorpha-derived recombinant hepatitis B (Hep B) surface antigen, Sanofi Pasteur, in Argentinean infants... CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) is highly immunogenic and safe when compared with licensed comparators, warranting further development.

Effect of high-flux hemodialysis on delayed hepatitis B virus vaccination response in hemodialysis patients. [2011.05]
OBJECTIVES: The aim of the study was to evaluate the effect of high-flux (HF) hemodialysis (HD) on delayed protective hepatitis B virus (HBV) antibody seroconversion in HD patients who had no response to the classic third dose of HBV vaccination... CONCLUSION: Hemodialysis patients who do not respond to the classic third dose of HBV vaccination could reobtain a delayed higher protective HBV antibody seroconversion rate by HF HD without other intervention.

Vaccination against hepatitis B among prisoners in Iran: accelerated vs. classic vaccination. [2011.05]
BACKGROUND: Prisoners and injecting drug users are at constant risk of hepatitis B virus (HBV) infection and the classic 6-months HBV vaccination might not provide immunization rapidly enough. In this randomized clinical trial we investigated the efficacy of an accelerated vaccination protocol vs. classic schedule among prisoners in Iran... CONCLUSION: Compared to classic HBV vaccination regimen, an accelerated 0, 1, 4 and 8 weeks vaccination schedule can achieve early seroprotection more rapidly, provides clinically sufficient seroprotection with higher compliance in prisoners and can be suggested in situations that rapid immunization against HBV infection is warranted. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

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Clinical Trials Related to Engerix-B (Hepatitis B Vaccine)

The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines [Completed]
This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained from the phase 1 clinical trial. The purpose of this study is to further evaluate the immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines and to explore the optimizing immunizing dose and immune procedure.

Study of Evaluating Safety and Immunogenicity of 10�g/0.5ml Hepatitis B Vaccine [Completed]
The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0. 5ml and 5µg/0. 5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.

Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060) [Completed]

Hepatitis B Vaccine Booster Study (V232-058) [Completed]
To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.

A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054) [Completed]
A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.

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