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hepatitis B vaccine (Engerix-B, Recombivax HB, Heplisav-B, Dynavax, PreHevbrio)

Indications: 1) immunization against infection caused by all known subtypes of hepatitis B virus 2) CDC, ACIP & AAP recommend routine immunization of infants 3) ACIP & AAP recommend vaccination of children & adolescents at risk for exposure to hepatitis B virus - infants born to hepatitis B-positive mothers [13] 4) patients <= 18 years of age [8] - advisory committee recommends all adults < 60 years be vaccinated for hepatitis B [19] 5) travelers to endemic areas [2] - Africa, Asia, Middle East, Southern Europe, some tropical areas 6) high-risk behaviors [4.17] a) intravenous drug abuse b) sexually transmitted disease c) more than 1 sex partner [8] d) men who have sex with men [8] 7) healthcare workers [4] 8) dialysis patients [4] 9) patients with diabetes mellitus ASAP after diagnosis [9] - diabetics < 60 years of age [10] 10) chronic liver disease [17] 11) HIV1 infection [17] Contraindications: - hypersensitivity to hepatitis B vaccine or any component Caution: 1) monitor for hypersensitivity, have epinephrine available 2) use with caution in patients with thrombocytopenia or bleeding disorder pregnancy-category C safety in lactation ? Dosage: Neonates 1) born to HBsAg+ mothers: a) 3 10 ug doses of Engerix-B b) 3 5 ug doses of Recombivax HB c) 1st dose within 7 days of birth (preferably within 12 h) d) booster doses at 1 month & 6 months* e) alternate schedule: 4 doses at 0, 1, 2 & 12 months* f) hepatitis B immune globulin 0.5 mL should be given at birth 2) born to HBsAg- mothers: a) 3 10 ug doses of Engerix-B b) 3 2.5 ug doses of Recombivax HB c) 1st dose before infant leaves hospital d) booster doses at 1-2 months & 6-18 months Children & adults: 1) 3 doses given at 0, 1 & 6 months - accelerated dosing at 0, 7 & 21-30 days + booster at 12 months - Heplisav-B: 2 doses 1 month apart [18] 2) children =<10 years a) Engerix-B: 10 ug IM b) Recombivax: 2.5 ug IM 3) children 11-19 years a) Engerix-B: 10 ug IM b) Recombivax: 5 ug IM 4) adults a) Engerix-B: 20 ug IM b) Recombivax: 10 ug IM 5) dialysis patients: a) Engerix: 40 ug doses b) administer each mL of vaccine at a different site 6) boosters not necessary for healthy healthcare workers, even after > 20 years [14] 7) if vaccine schedule is interrupted, resume (rather than restart) vaccination schedule [8] * HBsAg in serum & HBsAb in serum 1 to 2 months after the final dose [15] Injection: Recombinant DNA 1) Engerix-B: hepatitis B surface antigen 20 ug/mL (0.5 & 1 mL vials) 2) Recombivax HB: hepatitis B surface antigen 10 ug/mL (0.5, 1 & 3 mL vials) Twinrix is combined hepatitis A/hepatitis B vaccine PreHevbrio is a 3-valent recombinant hepatitis B vaccine Pharmacokinetics: 1) elimination: liver 2) immunity persists for > 10 years [5] Adverse effects: 1) common (> 10%) - mild local tenderness - local inflammatory reaction - fever - malaise - fatigue - headache 2) less common (1-10%) - nausea, diarrhea, pharyngitis 3) 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 4) other - no increase in risk of myocardial infarction with 2-dose vs 3-dose series [20] Laboratory: - HBsAb in serum in > 10 mIU/mL implies immunity [8] 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] - deaths from chronic liver disease & hepatocellular carcinoma markedly diminished in Taiwan following the launch of a nationwide HBV vaccination program for newborns in 1984 [11] - Heplisav-B (Dynavax) FDA-approved Nov 2017 after 2 rejections in 4 years for safety reasons [16]

General

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: 12439800
  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: 16226616
  7. Mikaeloff Y et al, Hepatitis B vaccination and the risk of childhood-onset multiple sclerosis. Arch Pediatr Adolesc Med 2007, 161:1176 PMID: 18056563
  8. Medical Knowledge Self Assessment Program (MKSAP) 14, 17, 19. American College of Physicians, Philadelphia 2006, 2015, 2022
  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 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a4.htm
  10. Prescriber's Letter 19(2): 2012 COMMENTARY: Hepatitis B Vaccination for Adults with Diabetes Detail-Document#: 280204 (subscription needed) http://www.prescribersletter.com
  11. Chiang C-J et al. Thirty-year outcomes of the national hepatitis B immunization program in Taiwan. JAMA 2013 Sep 4; 310:974. PMID: 24002285
  12. Centers for Disease Control and Prevention CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Posteexposure Management/ MMWR Weekly. Dec 20, 2013 http://www.cdc.gov/mmwr/PDF/rr/rr6210.pdf
  13. Kubo A et al Prevention of Vertical Transmission of Hepatitis B: An Observational Study. Ann Intern Med. Published online 27 May 2014. PMID: 24862434 http://annals.org/article.aspx?articleid=1876817
  14. Gara N et al. Durability of antibody response against hepatitis B virus in healthcare workers vaccinated as adults. Clin Infect Dis 2015 Feb 15; 60:505. PMID: 25389254 http://cid.oxfordjournals.org/content/60/4/505
  15. Schillie S, Murphy TV, Fenlon N et al Update: Shortened Interval for Postvaccination Serologic Testing of Infants Born to Hepatitis B-Infected Mothers. MMWR. Weekly. October 9, 2015 / 64(39);1118-20 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6439a6.htm
  16. Lowes R Heplisav-B Vaccine for Hep B Finally Wins FDA Approval Medscape - Nov 10, 2017. https://www.medscape.com/viewarticle/888411
  17. Abara WE, Qaseem A, Schillie S et al Hepatitis B Vaccination, Screening, and Linkage to Care: Best Practice Advice From the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. Nov 21, 2017 PMID: 29159414 http://annals.org/aim/fullarticle/2664089/hepatitis-b-vaccination-screening-linkage-care-best-practice-advice-from
  18. NEJM JWatch Editors ACIP Endorses New Hepatitis B Vaccine. Physician's First Watch, Feb 22, 2018 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org - MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) Feb. 12, 2018 https://www.cdc.gov/vaccines/acip/meetings/downloads/agenda-archive/agenda-2018-02-508.pdf - Schillie S, Harris A, Link-Gelles R, Romero J, Ward J, Nelson N. Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant. MMWR Morb Mortal Wkly Rep 2018;67:455-458 https://www.cdc.gov/mmwr/volumes/67/wr/mm6715a5.htm
  19. AMA Morning News. Nov 4, 2021 American Medical Association - Walker M ACIP: All Adults Ages 59 and Younger Should Get Hep B Vaccine. Committee also passed new recommendations on vaccines against Ebola, orthopoxviruses. MedPage Today November 3, 2021 https://www.medpagetoday.com/meetingcoverage/acip/95427
  20. Bruxvoort K, Slezak J, Qian L et al Association Between 2-Dose vs 3-Dose Hepatitis B Vaccine and Acute Myocardial Infarction. JAMA. Published online March 25, 2022 PMID: 35333303 https://jamanetwork.com/journals/jama/fullarticle/2790492

Component-of

acellular pertussis vaccine/diphtheria toxoid/haemophilus B vaccine/hepatitis B vaccine/poliovirus inactivated vaccine/tetanus toxoid (DtaP-HepB-IPV) acellular pertussis vaccine/diphtheria toxoid/hepatitis B vaccine/poliovirus inactivated vaccine/tetanus toxoid (DtaP-HepB-IPV) acellular pertussis vaccine/hepatitis b surface antigen/hepatitis b vaccine/poliovirus vaccine inactivated/tetanus toxoid haemophilus b conjugate meningococcal protein conjugate vaccine/hepatitis b vaccine haemophilus b vaccine/hepatitis b vaccine Haemophilus influenzae b/Hepatitis B vaccine (HepB-Hib) hepatitis a vaccine/hepatitis b vaccine (Twinrix) hepatitis b vaccine/haemophilus b conjugate vaccine meningococcal protein conjugate hepatitis a vaccine/hepatitis b vaccine (Twinrix)