Hepatitis B Vaccine

1. Indications
   1. All Newborns (at birth, age 2 months, and age 6 months)
   2. All health care personnel
   3. Hemodialysis patients
   4. Patients requiring frequent Blood Transfusion
   5. Staff and residents at developmentally disabled home
   6. Male homosexuals and their sexual contacts
   7. Intravenous Drug Abuse
   8. Sexual contacts of chronic HBsAg carriers
   9. Consider for areas of high prevelance
      1. Asia
      2. Sub-Saharan Africa
   10. Diabetes Mellitus under age 60 years
       1. Diabetes patients are twice as likely to contract Hepatitis B and more prone to liver disease and to develop chronic hepatitis
       2. Consider for older age 60 years with additional risks (but lower efficacy in this group)
       3. (2012) Presc Lett 19(2): 8-9
2. Contraindications
   1. Anaphylactic reaction to baker's yeast
3. Efficacy
   1. Starting series after age 3 months may improve immunity
   2. Immunity appears to be lifelong after series
   3. Perinatal and childhood exposure once accounted for one quarter of Chronic Hepatitis B
      1. Since 2004, >92% of U.S. children have complete Hepatitis B immunity
   4. References
      1. Kim (1997) Pediatrics 99:534-6 [PubMed]
      2. Kane (2000) Lancet 355:561 [PubMed]
4. Available Preparations
   1. Recombivax HB
      1. Infants, Children and Adolescents: 5 ug/dose
      2. Adults: 10 ug/dose
      3. Immunosuppressed Adult: 20 ug/dose
   2. Energix-B (SKB)
      1. Infants and Children: 10 ug/dose
   3. Twinrix (Combined Hepatitis A and Hepatitis B Vaccine)
      1. Adults: 720 EU/20 ug (1.0 ml)
      2. Not approved for use in Children
      3. Requires 3 doses as in Hepatitis B Vaccine schedule
5. Dosage: Protocols for Standard Schedule (Harmonized Schedule)
   1. Dose 1: Birth to age 2 months (first dose at age >1 month if birth weight <2000 grams)
   2. Dose 2: Age 1 to 4 months (>1 month after dose 1)
   3. Dose 3: Age 6 to 18 months (>2 months after dose 2)
6. Alternative Protocols
   1. Rapid Vaccination (3 weeks) French Study
      1. French Protocol
         1. Regular: Days 0, 28, and 56
         2. Rapid: Days 0, 10, and 21
      2. Efficacy compared with regular French schedule
         1. Day 28: Higher seroprotection than reg schedule
         2. Day 56: Lower seroprotection than regular
         3. Day 365: Same seroprotection as regular schedule
      3. References
         1. Marchou (1995) J Infect Dis 172:258-60 [PubMed]
   2. Moderately Rapid Vaccination schedule
      1. Rapid Schedule: months 0, 1, and 2
      2. Efficacy
         1. Month 3: Greater seroprotective effect
         2. Month 7: Equivalent seroprotection (100%)
            1. Higher Antibody titer for standard group
            2. Suggests possible longer term protection
      3. References
         1. Marsano (1996) Am J Gastroenterol 91:111-5 [PubMed]
7. Management: Infant with HBsAg Positive Mother
   1. Administer HBig and Hepatitis B Vaccine
      1. Hepatitis B Immunoglobulin (HBIG)
         1. Dose: 0.5 ml within 12 hours of birth
      2. Hepatitis B Vaccine starting with dose in hospital
         1. Dose 1: Within 12 hours of birth
         2. Dose 2: Age 1 months
         3. Dose 3: Age 6 months
         4. Additional Dose: Age 2 months if birth weight <2000 grams
   2. Labs at 9 and 15 months of age
      1. Hepatitis B Surface Antigen (HBsAg)
      2. Hepatitis B Surface Antibody (HBsAb)
8. Precautions
   1. Safe in HIV
      1. See Immunization in HIV
   2. Safe in Pregnancy
      1. See Immunization in Pregnancy
9. Adverse Effects
   1. Anaphylaxis (in those with yeast allergy)
   2. One serious reaction per 600,000 doses
   3. References
      1. (1996) MMWR Morb Mortal Wkly Rep 45(No. RR-12):1-35 [PubMed]
10. References
    1. (2001) Med Lett Drugs Ther 43(1110):67-8 [PubMed]
    2. Ackerman (2015) Am Fam Physician 92(6): 460-8 [PubMed]