II. Indications

  1. All medically stable newborns >2000 g within 24 hours of birth (then at age 2 months, and age 6 months)
  2. Unvaccinated infants and children
  3. All unvaccinated adults age 19 to 59 years old (or over age 60 years by risk or request)
    1. Added in CDC recommendation for 2022
  4. All health care personnel
  5. All pregnant patients
  6. Hemodialysis patients
  7. Patients requiring frequent Blood Transfusion
  8. Staff and residents at developmentally disabled home
  9. Incarceration
  10. Male homosexuals and their sexual contacts
  11. Intravenous Drug Abuse
  12. HIV Infection
  13. Chronic Liver Disease
  14. Sexual contacts of chronic HBsAg carriers
  15. Consider for areas of high prevelance (Asia, Sub-Saharan Africa)
  16. Diabetes Mellitus under age 60 years
    1. Diabetes patients are twice as likely to contract Hepatitis B
    2. Diabetes patients are more prone to liver disease and to develop chronic hepatitis
    3. Consider for older age 60 years with additional risks (but lower efficacy in this group)
    4. (2012) Presc Lett 19(2): 8-9

III. Contraindications

  1. Anaphylactic reaction to baker's yeast

IV. 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 BImmunity
    2. Indications
  4. References
    1. Kim (1997) Pediatrics 99:534-6 [PubMed]
    2. Kane (2000) Lancet 355:561 [PubMed]

V. Protocol: Immunity Confirmation

  1. Indications (High risk groups only)
    1. Hemodialysis
    2. Immunocompromised
    3. HIV Infection
    4. Sexual partners of those positive for HBsAg
    5. Healthcare personnel
  2. Protocol
    1. Confirm Immunity with HBsAb at 1-2 months after Vaccination in high risk groups
    2. Consider immune if HBsAb >=10 mIU (responder)
    3. If HBsAb <10 mIU (non-responder)
      1. Perform a second complete Vaccination series OR give a single additional Vaccine dose
      2. Recheck HBsAb again at 1-2 months after Vaccination
  3. References
    1. Schillie (2018) MMWR Morb Mortal Wkly Rep 67(15): 455-8 [PubMed]

VI. 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. Heplisav-B
    1. Two dose series
  4. PreHevbrio
    1. Indicated as a Hepatitis B Vaccine option in non-pregnant adults
    2. Three Antigen recombinant Hepatitis B Vaccine (Tri-Antigenic Vaccine)
      1. Antigens: Small (S), Middle (pre-S2), Large (pre-s1)
      2. Other Hepatitis B Vaccines (Energix-B, Recombivax HB, Hepislav-B) have only single, small (S) Antigen
    3. Appears more immunogenic than other, single Antigen preparations
    4. Associated with more local pain, as well as myalgias, Headache, Fatigue than with the other preparations
    5. Administer in 3 doses at 0, 1, and 6 months
    6. Vesikari (2021) Lancet Infect Dis 21:1271 [PubMed]
    7. (2022) Med Lett Drugs Ther 64(1650): 73-5
  5. Twinrix (Combined Hepatitis A and Hepatitis B Vaccine)
    1. Adults: 720 EU/20 ug (1.0 ml)
    2. Not approved for use in Children (age <18 years)
    3. Requires 3 doses as in Hepatitis B Vaccine schedule

VII. Dosing: Standard

  1. Protocols for Children on Standard Schedule (Primary Series or Harmonized Schedule)
    1. Dose 1: Birth to age 2 months
      1. Typically given in U.S. within 24 hours of birth for all medically stable infants
      2. 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, and age for final dose >=6 months from first dose)
  2. Adult and Adolescent Catch-Up Immunizations
    1. See Twinrix (age >18 years)
    2. Engerix-B or Recombivax-HB (3 dose series)
      1. Dose 1: Month 0
      2. Dose 2: Month 1 (at least 4 weeks after dose 1)
      3. Dose 3: Month 6 (at least 8 weeks after dose 2, 16 weeks after dose 1)
    3. Heplisav-B (2 dose series for age >18 years)
      1. Dose 1: Month 0
      2. Dose 2: Month 1 (at least 4 weeks after dose 1)
    4. Recombivax HB (2 dose series for age 11 to 15 years)
      1. Dose 1: Month 0
      2. Dose 2: Month 4 (at least 4 months after dose 1)

VIII. Protocols: Alternative

  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]

IX. Management: Infant with HBsAg Positive Mother (or Unknown Status)

  1. Administer HBig and Hepatitis B Vaccine
    1. Hepatitis B Immunoglobulin (HBIG)
      1. Dose: 0.5 ml within 12 hours of birth
      2. If maternal HepBsAg status unknown and birth weight >2000 g, may delay HBIG <7 days while awaiting HepBsAg
    2. Hepatitis B Vaccine starting with dose in hospital
      1. Dose 1: Within 12 hours of birth
        1. Give regardless of birth weight, in different extremity than the HBIG dose
      2. Dose 2: Age 1 months
      3. Dose 3: Age 6 months
      4. Additional, fourth Dose: Age 2 months if birth weight <2000 grams
  2. Labs at 9 to 12 months of age (or 1 month after completing series)
    1. Hepatitis B Surface Antigen (HBsAg)
    2. Hepatitis B Surface Antibody (HBsAb)

X. Precautions

  1. Safe in HIV
    1. See Immunization in HIV
  2. Safe in Pregnancy
    1. See Immunization in Pregnancy

XI. 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]

XII. Resources

  1. CDC Immunization Schedules (last accessed 10/28/2020)
    1. https://www.cdc.gov/vaccines/schedules/

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Related Studies

Ontology: Hepatitis B Vaccine (C0062527)

Definition (HL7V3.0) <p>hepatitis B vaccine, NOS</p>
Definition (NCI) A non-infectious mixture containing recombinant hepatitis B surface antigen (HBsAg) in a liquid vehicle. Immunization with the hepatitis B vaccine induces the formation of specific anti-hepatitis B antibodies and an active immunity against hepatitis B infection.
Definition (PDQ) A non-infectious mixture containing recombinant hepatitis B surface antigen (HBsAg) in a liquid vehicle. Immunization with the hepatitis B vaccine induces the formation of specific anti-hepatitis B antibodies and an active immunity against hepatitis B infection. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=532310&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=532310&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C29091" NCI Thesaurus)
Concepts Amino Acid, Peptide, or Protein (T116) , Pharmacologic Substance (T121) , Immunologic Factor (T129)
SnomedCT 34689006, 396424005
CPT 90740, 90743, 90746, 90747, 90744, 90739
HL7 45
English Hepatitis B Virus Vaccine, hepatitis B vaccine, HEPATITIS B, Hepatitis B Virus Vaccine,Recb, Hepatitis B Vaccine, hepatitis B vaccine recombinant, hepatitis b vaccine, hepatitis b vaccines, Hepatitis B Vaccine (Recombinant), Recombinant Hepatitis B Vaccine, HBIG - Hepatitis B vaccine, Hep B - Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B virus vaccine, Hepatitis B virus vaccine (product), Hepatitis B virus vaccine (substance), Hep B, NOS, HEPATITIS B VACCINE (RECOMBINANT)
Spanish vacuna contra el virus de la hepatitis B (producto), vacuna contra el virus de la hepatitis B (sustancia), vacuna contra el virus de la hepatitis B