Engerix B is a recombinant Hepatitis B vaccine that is used to induce active immunity against all hepatitis B subtypes.

Recombinant hepatitis B vaccines Uses:

• Hepatitis B disease prevention:

  • Vaccination against infection brought induced by all recognised hepatitis B virus strains (HBV)accination against infection brought induced by all recognised hepatitis B virus strains (HBV)
  • The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for the following:
    • All newborns (regardless of weight) born to mothers who were either HBsAg positive or who were not sure of their status (administer the first dose within 12 hours of birth).
    • Any newborns under 2 kg (e.g., term) born to a woman who tests negative for HBsAg (administer the first dose within 24 hours of birth).
    • All infants born to HBsAg-negative mothers who are under 2 kg (for example, premature babies) (administer the first dose at 1 month of age or prior to hospital discharge).
    • All unvaccinated newborns, kids, and teenagers who are under 19 years old.
    • Adults seeking immunity against HBV infection who are unvaccinated.
    • Adults without vaccination are at risk for HBV infection, including those who haveAll newborns (regardless of weight) born to mothers who were either HBsAg positive or who were not sure of their status (administer the first dose within 12 hours of birth).
    • Any newborns under 2 kg (e.g., term) born to a woman who tests negative for HBsAg (administer the first dose within 24 hours of birth).
    • All infants born to HBsAg-negative mothers who are under 2 kg (for example, premature babies) (administer the first dose at 1 month of age or prior to hospital discharge).
    • All unvaccinated newborns, kids, and teenagers who are under 19 years old.
    • Adults seeking immunity against HBV infection who are unvaccinated.
    • Adults without vaccination are at risk for HBV infection, including those who have

Behavioral risks:

• Men who have sex with men.Men who have sex with men.
• Persons seeking evaluation or treatment for a sexually transmitted disease.
• Injection drug users.
• Sexually-active persons with >1 partner in a 6-month period.Sexually-active persons with >1 partner in a 6-month period.

Occupational risks:

• Workers in public safety and healthcare who face a foreseeable danger of coming into contact with blood or body fluids tainted by it.Workers in public safety and healthcare who face a foreseeable danger of coming into contact with blood or body fluids tainted by it.

Medical risks:

• Those who have advanced renal disease.
• Those who are HIV positive.
• Individuals with chronic liver illness (such as autoimmune hepatitis, cirrhosis, fatty liver disease, alcoholism, or ALT or AST levels >2 times the upper limit of normal).
• Adults with type 1 or type 2 diabetes who are between the ages of 19 and 59
• Depending on the chance that they would contract HBV infection, adults 60 years old with diabetes mellitus may also receive the vaccine at the treating physician's discretion.those who have advanced renal disease.
• Those who are HIV positive.
• Individuals with chronic liver illness (such as autoimmune hepatitis, cirrhosis, fatty liver disease, alcoholism, or ALT or AST levels >2 times the upper limit of normal).
• Adults with type 1 or type 2 diabetes who are between the ages of 19 and 59
• Depending on the chance that they would contract HBV infection, adults 60 years old with diabetes mellitus may also receive the vaccine at the treating physician's discretion.

Other risks:

• Household members or sexual partners of HBsAg-positive people, those living in or working in facilities for the developmentally challenged, people travelling internationally to areas with high or moderate levels of endemic HBV infection, and people who are incarcerated are also at risk.
• Additionally, the ACIP advises vaccination for anyone hurt in bombings or other mass casualty incidents who has penetrating wounds, non-intact skin exposure, or contact with mucous membranes (exception: superficial contact with intact skin), and who cannot vouch for having received a hepatitis B vaccination (CDC [Chapman 2008]).

Engerix B (recombinant Hepatitis B vaccine) Dose in Adults

Engerix B (recombinant Hepatitis B vaccine) Dose in the treatment of Primary immunization: IM:

Note:

• Although the adult hepatitis B vaccine formulations differ in terms of concentration (mcg/mL), when dosed in terms of volume (mL), Engerix-B and Recombivax HB have the same dose (both 1 mL).
• For dosage instructions for adult patients with chronic renal disease and/or dialysis, see Dosing: Renal Impairment. Recombivax HB adult formulation includes 10 mcg/mL and Recombivax HB dialysis formulation contains 40 mcg/mL.
   

• Immunocompetent adults (non-dialysis):

  • 3 doses total, given at 0, 1, and 6 months, of 1 mL/dose (adult formulation).

Engerix B (recombinant Hepatitis B vaccine) Dose in the treatment of adults with immunocompromising conditions (off-label):

Note:

• Despite the lack of evidence, some doctors advocate using the high-dose (40 mcg) hepatitis B vaccine in individuals with immunocompromising diseases (such as HIV infection, cirrhosis, transplantation, or chemotherapy).

• Engerix-B 20 mcg/mL:

  • Administer 2 mL per dose at 0, 1, 2, and 6 months

• Recombivax HB 40 mcg/mL:

  • Administer 1 mL per dose at 0, 1, and 6 months

Revaccination: IM:

• Healthcare professionals (HCP):
  • Give an additional dose of hepatitis B to HCPs who have had their full vaccination and whose anti-HBs levels are below 10 milliunits/mL. Test for anti-HBs one to two months afterwards.
  • Continue with the vaccine series if anti-HBs levels are still less than 10 microunits/mL. Test for anti-HBs 1 to 2 months later.
  • In contrast, HCPs with anti-HBs levels below 10 milliunits/mL may have a second, full 3-dose vaccination series, followed by a reevaluation of anti-HBs levels one to two months after the final dose.

Engerix B (recombinant Hepatitis B vaccine) Dose in the Bombings or similar mass-casualty events:

• IM: Vaccination should start within 24 hours (but no later than 7 days) of the occurrence in those without a reliable history of HepB vaccination and who have no known contraindications to the vaccine.

Engerix B (recombinant Hepatitis B vaccine) Dose in the Postexposure management of health care personnel: IM:

• Documented vaccine responder:

  • No further hepatitis B vaccination is required, regardless of the patient's HBsAg status, if the HCP has prior evidence of 3 doses of a hepatitis B vaccine and a postvaccination anti-HBs 10 milliunits/mL. HCP is thought to be seroprotected.

• Unvaccinated or incompletely vaccinated:

  • As soon as practical after exposure, test the source patient for HBsAg. Give the HCP the full course of the hepatitis B vaccine; if the source patient has HBsAg positivity or the status is uncertain, start the immunisation series as soon as you can (with a dose of HBIG).
  • Tests for anti-HBs should be performed 1 to 2 months following the last dose of the vaccine.
  • Anti-HBs testing should be done 1 to 2 months following the last dose of the vaccine series if the HCP's anti-HBs levels are less than 10 milliunits/mL.

• Vaccinated with 3 doses of hepatitis B vaccine but postvaccination anti-HBs status is unknown: Test HCP for anti-HBs.

  • No further hepatitis B vaccination is required if anti-HBs are less than 10 milliunits/mL.
  • If the source patient's status is HBsAg positive or unknown and the anti-HBs level is less than 10 micrograms per millilitre, revaccinate the HCP with a full 3-dose vaccination series and provide one dose of HBIG as soon as possible.
  • One to two months following the last dose of the vaccine, anti-HBs testing should be performed.
  • Anti-HBs testing should be done 1–2 months after the HCP receives a single dose of the vaccination if anti-HBs is 10 microunits/mL and the source patient is HBsAg negative.
  • Anti-HBs testing should be done 1 to 2 months following the final dose of the vaccination and 2 more vaccine doses should be given if antiHBs levels are still below 10 milliunits/mL.

• Vaccinated with 6 doses of hepatitis B vaccine (2 complete series) but documented as a non-responder to the vaccine:

  • There is no post-exposure vaccination advised.
  • Give two doses of HBIG spaced by a month if the source patient has HBsAg or if the status is uncertain.

Engerix B (recombinant Hepatitis B vaccine) Dose in the Postexposure management in nonoccupational settings: IM:

• Documented vaccine recipient without post-vaccination anti-HBs testing:

  • Give a single dose of the hepatitis B vaccine if exposure came from a source that tested positive for HBsAg.
  • If the source of the exposure to HBsAg was unknown, no further therapy was necessary.

• Vaccination in the process:

  • Completing the immunisation course.
  • Give a dosage of HBIG as well if exposure came from a source that tested positive for HBsAg.

• Unvaccinated:

  • Provide the hepatitis B vaccination and HBIG as soon as feasible (ideally within 24 hours of exposure [7 days for percutaneous exposure or 14 days for sexual exposure]) if exposure was to an HBsAg-positive source;
    completing the immunisation course.
  • If the source of the HBsAg exposure was unknown, deliver the full course of vaccinations.

Engerix B (recombinant Hepatitis B vaccine) Dose in Childrens

Note: Although hepatitis B vaccination products vary in concentration (mcg/mL), the equivalent dose is the same among brands when measured in terms of volume (mL) (ie, 0.5 mL of Recombivax-HB is equivalent to 0.5 mL of Engerix-B).

Engerix B (recombinant Hepatitis B vaccine) Dose in the Primary immunization:

CDC (ACIP) recommendations:

• Infants: Recombivax-HB, Engerix-B (Pediatric/Adolescent formulation):

  • IM: 3 doses totaling 0.5 mL each are administered as follows:
  • Preferably, the first dose is given at birth, the second dose is given between 1 and 2 months of age, and the third dose is given between 6 and 18 months of age. The minimum age for the final (third) dose is 24 weeks.

• Infants born to HBsAg-negative mothers:

  • First dose:

    • 5 mL within 24 hours of birth

  • Second dose:

    • 5 mL at 1 to 2 months of age

  • Third dose:

    • 5 mL at 6 to 18 months of age.
    • The final dose should be administered no earlier than 24 weeks of age, or 8 weeks after the second dose and 16 weeks after the first dose.
    • The final dosage needs to be given to children between the ages of 6 and 12 months in populations where childhood HBV infection rates are currently or have historically been high.

Note: The initial dose should be postponed until 30 days of chronological age or at hospital release for former preterm infants weighing less than 2 kg.

• Infants born to HBsAg- positive mothers:

Preterm newborns should receive a 4-dose series due to possible diminished immunogenicity; former term neonates and infants should receive the customary 3-dose series.

• First dose:
  • 5 mL should be administered within the first 12 hours of life, regardless of birth weight or prematureness, and at the same time at a separate anatomical place.
• Second dose:5 mL
  • Birthweight <2 kg (eg, preterm): At 1 month of age
  • Birthweight ≥2 kg (eg, term): At 1 to 2 months of age
• Third dose:5 mL
  • Birthweight <2 kg (eg, preterm): At 2 to 3 months of age
  • Birthweight ≥2 kg (eg, term): Final dose: At 6 months of age. This dose should be given ≥8 weeks after the second dose and ≥16 weeks after the first dose, but no sooner than 24 weeks of age.
• Fourth dose:
  • Birthweight <2 kg (eg, preterm): Final dose: At least 6 months of age (24 weeks)

• Follow-up serologic testing after completion of vaccine series:

  • At 9 to 12 months of age, anti-HBs and HBsAg levels should be assessed.
  • No additional action is required if the level is below 10 milliunits/mL.
  • If anti-HBs levels are less than 10 milliunits/mL and the patient tests negative for HBsAg, revaccinate with one dose of the vaccine, then reevaluate 1 to 2 months later.
  • Give two further doses of the vaccine to finish the second immunisation series if anti-HBs levels are still below 10 microunits per millilitre. One to two months following the last dose, check anti-HBs levels again.
  • A second, full 3-dose vaccination series may be given to HBsAg-negative newborns with anti-HBs levels under 10 milliunits/mL, followed by a reevaluation of anti-HBs and HBsAg levels 1 to 2 months after the final dose.

• Infants born to mothers whose HBsAg status is unknown at birth:

  • Birthweight <2 kg (eg, preterm): Manage as if born to HBsAg-positive mother (ie, a birth dose of the vaccine not counted in series); once maternal status determined, follow an applicable schedule.
  • Birthweight ≥2 kg (eg, term): Manage as if born to HBsAg-positive mother; once maternal status determined, follow an applicable schedule.

Canadian labeling:

• Pediatric/adolescent formulation, 5 mL/dose, 3 doses total, given at 0, 1, and 6 months.
• A 4-dose series can be given at 0, 1, and 2 months, followed by a booster at 12 months, for faster protection.

Engerix B (recombinant Hepatitis B vaccine) Dose in the Catch-up immunization:

Note:

• Avoid starting the series over.
• If doses have been administered, start the regimen below at the corresponding dose number.

• Recombivax-HB, Engerix-B (Pediatric/Adolescent formulation):

  • Infants ≥4 months, Children, and Adolescents: IM:
    • 0.5 mL per dose for 3 total doses.

• Recombivax HB (Adult formulation):

  • Adolescents 11 to 15 years: IM:
    • 1 mL per dose for 2 doses;
    • If the patient is still under the age of 15, the first dose is given on the chosen day, and the second dose is given 4 to 6 months later.

Engerix B (recombinant Hepatitis B vaccine) Dose in the Bombings or similar mass casualty events:

• IM: Vaccination should start within 24 hours (but no later than 7 days) of the occurrence in those without a reliable history of hepatitis B vaccination and who have no known contraindications to the vaccine.

Pregnancy Risk Category: C

• The concept that maternal exposure to the hepatitis-B vaccine increases the chance of miscarriage or serious birth abnormalities is not supported by the research.
• Every expectant woman should undergo a HbsAg test.
• Getting vaccinated while expecting is not dangerous. However, vaccination is advised for people who are most at risk of contracting HBV.
• For pregnant women, refer to the current immunization schedule.

HepB vaccines use during breastfeeding:

• It is unknown if the vaccine is found in breast milk.
• The manufacturer suggests that you consider the risks of infant exposure, the benefits to breastfeeding and the benefits to vaccination for the mother.
• Breastfeeding is allowed provided that you are not pregnant.
• The administration of the medication does not affect breastfeeding safety for either the mother nor the infant.
• Infants who are being breastfed must receive their necessary vaccinations on time.
• Infants born to HBsAg-positive moms who have taken postexposure prophylaxis are eligible to start breastfeeding right away.
• It is not necessary for female healthcare professionals to stop breastfeeding as part of their post-exposure treatment after receiving the hepatitis B vaccine.

Engerix B (recombinant Hepatitis B vaccine) Dose in Kidney Disease:

• ≥20 years:

  • Chronic kidney disease: Recombivax HB 40 mcg/mL: IM:
    • Administer 1 mL per dose at 0, 1, and 6 months

• Dialysis patients: IM:

  • Engerix-B 20 mcg/mL:
    • Administer 2 mL per dose at 0, 1, 2, and 6 months
  • Recombivax HB 40 mcg/mL:
    • Administer 1 mL per dose at 0, 1, and 6 months

Note:

• To assess the need for booster doses, serologic testing is advised one to two months after the last dose of the initial vaccine series and once a year.
• A booster dosage should be given to those with anti-HBs values of 10 milliunits/mL.

Engerix B (recombinant Hepatitis B vaccine) Dose in Liver disease:

There are no dosage adjustments provided in the manufacturer’s labeling.

Side effects of Engerix B (recombinant Hepatitis B vaccine):

The most common adverse effects reported with both products included injection site reactions (>10%).

• Cardiovascular:

  • Hypotension
  • Flushing

• Central Nervous System:

  • Drowsiness
  • Chills
  • Tingling Sensation
  • Dizziness
  • Fatigue
  • Insomnia
  • Malaise
  • Headache
  • Paresthesia
  • Irritability
  • Vertigo
  • Body Pain

• Dermatologic:

  • Pruritus
  • Urticaria
  • Skin Rash
  • Diaphoresis

• Gastrointestinal:

  • Stomach Cramps
  • Anorexia
  • Dyspepsia
  • Decreased Appetite
  • Nausea
  • Diarrhea
  • Vomiting
  • Abdominal Pain

• Genitourinary:

  • Dysuria

• Hematologic & Oncologic:

  • Lymphadenopathy

• Hypersensitivity:

  • Angioedema

• Infection:

  • Influenza

• Local:

  • Injection Site Nodule
  • Erythema At Injection Site
  • Tenderness At Injection Site
  • Induration At Injection Site
  • Swelling At Injection Site
  • Itching At Injection Site
  • Pain At Injection Site
  • Local Soreness/Soreness At Injection Site
  • Warm Sensation At Injection Site
  • Bruising At Injection Site

• Neuromuscular & Skeletal:

  • Neck Pain
  • Back Pain
  • Shoulder Pain
  • Myalgia
  • Neck Stiffness
  • Weakness
  • Arthralgia

• Otic:

  • Otalgia

• Respiratory:

  • Rhinitis
  • Pharyngitis
  • Upper Respiratory Tract Infection
  • Cough

• Miscellaneous:

  • Fever (≥37.5°C/100°F)

Contraindications to Engerix B (recombinant Hepatitis B vaccine):

• Significant hypersensitivity or allergic reaction to any ingredient in this formulation, including yeast, the hepatitis B vaccine, or both.
• Severe febrile illness is likewise included in Canadian labelling.

Warnings and precautions

• Anaphylactoid reactions and hypersensitivity reactions

  • Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use.

• Syncope

  • Syncope can be caused by injectable vaccines. It is most common in young adults and adolescents, and usually occurs within 15 minutes of vaccination.
  • It is important to have procedures in place to prevent injuries from falling, and to restore cerebral perfusion in the event of syncope.

• Acute illness:

  • The severity of the symptoms and the etiology determine whether or not vaccination should be administered.
  • Patients should not be administered to if they have a fever and a severe or moderate acute sickness.
  • Patients with minor acute diseases (fever or not) should have their shots right away.
  • The use of the vaccination in patients with severe febrile illness is prohibited by Canadian labelling.

• Bleeding disorders:

  • Patients with bleeding disorders, including thrombocytopenia, should be cautious. IM administration may cause bleeding/hematoma.
  • IM injections can be planned within a few hours if the patient has had anti-hemophilia therapy or a similar therapy.

• Multiple sclerosis

  • Exacerbations of multiple sclerosis (MS) have been linked to vaccination. Clinical research, however, reveals no connection between MS and immunisation.

Monitoring parameters:

• After injection, observe for 15 minutes for syncope and anaphylaxis (ACIP [Kroger 2017]).
• Maintain the patient in a supine or Trendelenburg position if seizure-like activity accompanied by syncope occurs in order to restore appropriate cerebral perfusion.
• Consider respiratory monitoring for 48 to 72 hours following dosing in preterm newborns.

How to administer Engerix B (recombinant Hepatitis B vaccine)?

• Do not administer IV or intradermally; intramuscular injection is recommended.
• The ideal site for administration is the deltoid muscle, not the gluteal area.
• At the same time but at a different anatomical place, HBIG can be injected.
• Vaccinate the patient while they are sitting or lying down to prevent accidents caused by syncope.
• For patients at risk of hemorrhage following intramuscular injection, administer subcutaneously.
• If the patient receives antihemophilic or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered.
• Use fine needle (23-gauge or smaller) to apply firm pressure for at least 2 minutes.
• Educate the patient about the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders.

Mechanism of action of Engerix B (recombinant Hepatitis B vaccine):

• Through the production of anti-hepatitis B antibodies, the recombinant Hepatitis B vaccination (noninfectious subunit virus vaccine) gives active immunity.
• The hepatitis B vaccine can be created by cloning the hepatitis B gene that produces HBsAg into yeast and cultivating it.

Efficacy:

• A complete series of postvaccination seroprotection was found in 98% of healthy infants, 95% of adolescents, >90% healthy adults 40 years old, and 75% patients >=60.
• Seroprotection for adult patients with chronic kidney disease was 60% in the case of those with diabetes mellitus, and 75% for those without.

Time:

• For immunocompetent individuals who received the entire three-dose hepatitis B series, protection against hepatitis B was >=30 years.

International Brand Names of recombinant Hepatitis B vaccine:

• Engerix-B
• Recombivax HB
• Amvax B
• Bio-Hep-B
• Engerix B
• Engerix-B
• H-B-Vax II
• HB-Vax
• HBvaxPRO
• HBvaxPro
• Hepavax Gene
• Hepliv
• Shanvac-B
• Temrevac-HB

Recombinant hepatitis B vaccine Brand Names in Pakistan:

• Engerix B