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.

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NEWS HIGHLIGHTS

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

WHO To Launch Yellow Fever Vaccination Campaign In West Africa
Source: Health News from Medical News Today [2009.11.19]
The WHO on Tuesday announced it would lead a week-long, multi-country vaccination campaign in Africa next week to protect those "deemed at highest risk from yellow fever," Reuters reports. The vaccination drive will target nearly 12 million Africans living in Benin, Liberia and Sierra Leone - all countries at high risk of yellow fever outbreaks (Nebehay/MacInnis, 11/17).

Blogs Comment On Abortion Issues In Health Reform, HPV Vaccinations For Immigrants
Source: Abortion News From Medical News Today [2009.11.18]
The following summarizes selected women's health-related blog entries. ~ "DeGette: Stupak Agenda Is Much Wider Restrictions on Abortion," Brian Beutler, Talking Points Memo: Rep. Diana DeGette (D-Colo.) "takes issue" with Rep. Bart Stupak's (D-Mich.

Senators Blame HHS for Mishandling H1N1 Vaccination Effort
Source: MedPage Today Infectious Disease [2009.11.17]
WASHINGTON (MedPage Today) -- Senators on the Homeland Security Committee scolded Health and Human Services Secretary Kathleen Sebelius Tuesday for overly optimistic estimates of pandemic H1N1 flu vaccine supplies.

The Diagnostic Clinic Introduces A Vaccination Alternative To The Flu Jab
Source: Flu / Cold / SARS News From Medical News Today [2009.11.12]
The Diagnostic Clinic in London's New Cavendish Street, the UK's premier centre for Integrated Medicine, offers a vaccination alternative for private and corporate patients not wishing to have the Flu or Swine Flu jab. Many people have concerns regarding vaccinations. Whether this is as simple as needle phobia or concerns over the safety of vaccinations, an alternative can be considered.

Potential Downside Of Yearly Influenza Vaccination For Children
Source: Bird Flu / Avian Flu News From Medical News Today [2009.11.02]
An article published Online First and in the December edition of The Lancet Infectious Diseases discusses the benefits and disadvantages of vaccination for children against seasonal flu. It reports that infection with "seasonal" influenza A could in fact benefit children by giving them improved immunity against pandemic strains such as the current swine flu H1N1 strain.

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

Recombinant interferon-alpha2b improves immune response to hepatitis B vaccination in haemodialysis patients: results of a randomised clinical trial. [2009.09.18]
The use of adjuvants capable of improving the deficient immune response to hepatitis B virus (HBV) vaccine in haemodialysis patients is highly needed. Among potential adjuvants, type I interferons deserve a special attention in view of their known effects promoting cellular and humoral immune responses...

Intradermal versus intramuscular hepatitis B vaccination in hemodialysis patients: a prospective open-label randomized controlled trial in nonresponders to primary vaccination. [2009.07]
BACKGROUND: Primary hepatitis B virus (HBV) vaccination through the intramuscular (IM) route is less efficacious in dialysis patients than in the general population. Previous studies suggest improved seroconversion with intradermal (ID) vaccination... CONCLUSIONS: Significantly greater seroconversion rates and peak antibody titers can be achieved with ID compared with IM vaccination in hemodialysis patients nonresponsive to primary vaccination. ID vaccination should become the standard of care in this setting.

Differences in the immune response to hepatitis B and Haemophilus influenzae type b vaccines in Guatemalan infants by ethnic group and nutritional status. [2009.06.02]
Ladino and native Indian Guatemalan infants developed high rates (96-100%) of protective antibodies after receiving conjugate Haemophilus influenzae type b and hepatitis B vaccines at 2, 4 and 6 months of age.

Safety and immunogenicity of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 3, 4, and 12-14 months of age. [2009.04.28]
Combination vaccines improve parental and provider satisfaction and schedule compliance by decreasing the number of injections. In a Phase 2, randomized, double-blind, multicenter study, we compared four formulations of a liquid, hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B virus (DTaP-IPV-Hib-HBV) vaccine in 708 infants immunized at 2, 3, 4, and 12-14 months of age...

Hepatitis B vaccination in haemodialysis patients: a randomized clinical trial. [2009.04]
AIM: A short vaccination protocol against hepatitis B was compared to the standard approach in patients under haemodialysis who were primarily non-responsive to the vaccine... CONCLUSION: In haemodialysis patients, a short vaccination protocol against hepatitis B did not provide any benefit compared to the standard approach with respect to peak anti-HBs titres or a higher rate of seroprotection at the end of follow up. Other strategies to increase seroconversion rates should be explored, especially in the elderly and in patients with hepatitis C.

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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 HEPLISAVâ„¢ 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 Engerixâ„¢-B [Completed]
The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerixâ„¢-B and hepatitis B vaccine new formulation when administered at 0, 6 months

Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerixâ„¢-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 Engerixâ„¢-B in haemodialysis patients with or without previous vaccination against hepatitis B

Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerixâ„¢-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 Engerixâ„¢-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months

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