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 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.

Use With Other Vaccines: The ACIP states that, in general, simultaneous administration of certain live and inactivated pediatric vaccines has not resulted in impaired antibody responses or increased rates of adverse reactions. ¹⁷ Separate sites and syringes should be used for simultaneous administration of injectable vaccines.

See all Engerix-B indications & dosage >>

NEWS HIGHLIGHTS

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

Study Explores Providers' Perceptions Of Parental Concerns About HPV Vaccination
Source: Health News from Medical News Today [2013.05.17]
A new Boston University School of Medicine (BUSM) study has found that low-income and minority parents may be more receptive to vaccinating their daughters against Human Papillomavirus (HPV), while white, middle-class parents are more likely to defer the vaccination. The findings appear online in the May issue of the Journal of Health Care for the Poor and Underserved. Cervical cancer incidence and mortality are markedly higher for low-income and minority women due to higher rates of HPV and limited access to screening and treatment...

HPV Vaccination Sends Genital Wart Cases Plummeting: Study
Source: MedicineNet Cervical Cancer Specialty [2013.04.19]
Title: HPV Vaccination Sends Genital Wart Cases Plummeting: Study
Category: Health News
Created: 4/18/2013 8:35:00 PM
Last Editorial Review: 4/19/2013 12:00:00 AM

Parents Who Veto Vaccinations Often Seek Like-Minded Opinions
Source: MedicineNet Chickenpox (Varicella) Specialty [2013.04.15]
Title: Parents Who Veto Vaccinations Often Seek Like-Minded Opinions
Category: Health News
Created: 4/15/2013 10:35:00 AM
Last Editorial Review: 4/15/2013 12:00:00 AM

Teen's Death From Chickenpox Highlights Need for Vaccination, CDC Reports
Source: MedicineNet Chickenpox (Varicella) Specialty [2013.04.12]
Title: Teen's Death From Chickenpox Highlights Need for Vaccination, CDC Reports
Category: Health News
Created: 4/11/2013 12:35:00 PM
Last Editorial Review: 4/12/2013 12:00:00 AM

We Need A Better Flu Vaccine Before Considering Mandatory Vaccination Of Health Care Workers
Source: Flu / Cold / SARS News From Medical News Today [2013.03.25]
Until we have a better influenza vaccine, it is premature to consider mandatory vaccination for health care workers, states a commentary published in CMAJ (Canadian Medical Association Journal). There has been an increasing push for mandatory vaccination of health care workers in Canada...

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

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.

Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. [2011.04.13]
CONTEXT: Alternative schedules more immunogenic than the standard hepatitis B vaccine regimen are needed in patients with human immunodeficiency virus 1 (HIV-1) infection. OBJECTIVE: To compare the safety and immunogenicity of 4 intramuscular double-dose and 4 intradermal low-dose regimens vs the standard hepatitis B vaccine regimen... CONCLUSION: In adults with HIV-1, both the 4 intramuscular double-dose regimen and the 4 intradermal low-dose regimen improved serological response compared with the standard HBV vaccine regimen. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00480792.

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

Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections [Active, not recruiting]
Hepatitis B immunization is offered to all grade 4 students (age9-10) in the province of Quebec, using Engerix-B at a dose of 10 mkg. The peak incidence of hepatitis B occurs between age 15 and 35; the proportion of vaccinated children who will still be protected at this age is currently unknown. This study is designed to determine:

- persistence of immunity until age 25

- persistence of immunological memory as demonstrated by an anamnestic response following

a booster dose

- the effect of a booster dose on immunogenicity at either 5, 10 or 15 years after the

primary vaccination course (at age (15, 20 or 25).

Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine [Active, not recruiting]
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.

Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B [Completed]
The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months

Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients [Completed]
This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B

Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules [Completed]
The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months

more trials >>