Hepatitis B Vaccine

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Contents 1 Indications 2 Contraindications 3 Dosage 4 Pharmacokinetics 5 Notes 6 More General Terms 7 References

Indications

• immunization against infection caused by all known subtypes of hepatitis B virus
• CDC, ACIP & AAP recommend routine immunization of infants
• ACIP & AAP recommend vaccination of children & adolescents at risk for exposure to hepatitis B virus
• patients <= 18 years of age [8]
• travelers to endemic areas [2]

• Africa, Asia, Middle East, Southern Europe, some tropical areas

• high-risk behaviors [4]

• intravenous drug abuse
• sexually transmitted disease
• more than 1 sex partner [8]
• men who have sex with men [8]

• healthcare workers [4]
• dialysis patients [4]
• patients with diabetes mellitus ASAP after diagnosis [9]

• diabetics < 60 years of age [10]

Contraindications

• hypersensitivity to hepatitis B vaccine or any component

• Caution:

• monitor for hypersensitivity, have epinephrine available
• use with caution in patients with thrombocytopenia or bleeding disorder

• pregnancy-category C
• safety in lactation ?

Dosage

• Neonates

• born to HBsAg+ mothers:

• 3 10 ug doses of Engerix-B
• 3 5 ug doses of Recombivax HB
• 1st dose within 7 days of birth (preferably within 12 h)
• booster doses at 1 month & 6 months
• alternate schedule: 4 doses at 0, 1, 2 & 12 months
• hepatitis B immune globulin 0.5 mL should be given at birth

• born to HBsAg- mothers:

• 3 10 ug doses of Engerix-B
• 3 2.5 ug doses of Recombivax HB
• 1st dose before infant leaves hospital
• booster doses at 1-2 months & 6-18 months

• Children & adults:

• 3 doses given at 0, 1 & 6 months
• children =<10 years

• Engerix-B: 10 ug IM
• Recombivax: 2.5 ug IM

• children 11-19 years

• Engerix-B: 10 ug IM
• Recombivax: 5 ug IM

• adults

• Engerix-B: 20 ug IM
• Recombivax: 10 ug IM

• dialysis patients:

• Engerix: 40 ug doses
• administer each mL of vaccine at a different site

• Injection:
• Recombinant DNA

• Engerix-B: hepatitis B surface antigen 20 ug/mL (0.5 & 1 mL vials)
• Recombivax HB: hepatitis B surface antigen 10 ug/mL (0.5, 1 & 3 mL vials)

• Twinrix is combined hepatitis A/hepatitis B vaccine

Pharmacokinetics

• elimination: liver
• immunity persists for > 10 years [5] Adverse reactions:

• common (> 10%)

• mild local tenderness
• local inflammatory reaction
• fever
• malaise
• fatigue
• headache

• less common (1-10%)

• nausea, diarrhea, pharyngitis

• uncommon (< 1%)

• sweating, sensation of warmth, lightheadedness, chills, flushing, somnolence, insomnia, irritability, agitation, arthralgia, myalgia, joint or neck stiffness, vomiting, constipation, abdominal cramps, dyspepsia, pruritus, anorexia, rash, erythema, urticaria, rhinitis, cough, epistaxis, earache, dysuria, tachycardia, hypotension

Notes

• a diminished response rate is found among older individuals [3]
• some studies have defined older as 30 years
• relative risk for failure to respond is 1.76 [3]

More General Terms

• vaccine

References

1. Kaiser Permanente Northern California Regional Drug Formulary, 1998
2. Prescriber's Letter 9(7):40 2002
3. Journal Watch 23(3):26, 2003 Fisman DN et al, Clin Infect Dis 35:1368, 2002 PMID: [1]
4. Prescriber's Letter 10(4):21 2003
5. Department of Veterans Affairs, VA National Formulary
6. Zanetti AR et al. Long-term immunogenicity of hepatitis B vaccination and policy for booster: An Italian multicentre study. Lancet 2005 Oct 15; 366:1379-84 PMID: [2]
7. Mikaeloff Y et al, Hepatitis B vaccination and the risk of childhood-onset multiple sclerosis. Arch Pediatr Adolesc Med 2007, 161:1176 PMID: [3]
8. Medical Knowledge Self Assessment Program (MKSAP) 14, American College of Physicians, Philadelphia 2006
9. Centers for Disease Control and Prevention Use of Hepatitis B Vaccination for Adults with Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR December 23, 2011 / 60(50);1709-1711 [4]
10. Prescriber's Letter 19(2): 2012 COMMENTARY: Hepatitis B Vaccination for Adults with Diabetes Detail-Document#: [5] (subscription needed) [6]
11. Vaccinations for Hepatitis A and B [7]
12. National Guideline Clearinghouse A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP) part 1: immunization of infants, children, and adolescents. Centers for Disease Control and Prevention ngc-guideline: [8]

hepatitis B vaccine (Engerix-B, Recombivax HB)