Hepatitis B vaccine

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sara Mehrsefat, M.D. [2]

Overview

Hepatitis B vaccine is the most effective tool in preventing the transmission of HBV and HDV. Vaccines are composed of the surface antigen of HBV (HBsAg) and are produced by two different methods: plasma-derived and recombinant DNA. The primary hepatitis B immunization series conventionally consists of three doses of vaccine. Vaccination of infants and, in particular, delivery of hepatitis B vaccine within 24 hours of birth is 90–95% effective in preventing HBV infection, as well as decreasing HBV transmission if followed by at least two other doses. WHO recommends universal hepatitis B vaccination for all infants and recommends that the first dose be given as soon as possible after birth.[1][2] This strategy has resulted in a dramatic decrease in the prevalence of CHB among young children in regions of the world where universal infant vaccination programs have been implemented. A proportion of vaccinated children (5–10%) have a poor response to vaccination, and will remain susceptible as adults to acquisition of HBV infection.[1][3] WHO recommends that hepatitis B vaccine be included in routine immunization services in all countries. The primary objective of hepatitis B immunization is to prevent chronic HBV infections, which result in chronic liver disease later in life. By preventing chronic HBV infections, the major reservoir for transmission of new infections is also reduced.[1]

Hepatitis B Vaccine

Hepatitis B vaccine is a vaccine developed for the prevention of hepatitis B virus infection. Hepatitis B vaccination is the most effective measure to prevent HBV infection and its consequences. Since they were first issued in 1982, recommendations for hepatitis B vaccination have evolved into a comprehensive strategy to eliminate HBV transmission in the United States.[4][5]

Recombinant DNA-derived vaccines against HBV have been available for more than two decades. The primary hepatitis B immunization series conventionally consists of three doses of vaccine. Vaccination of infants and, in particular, administration of hepatitis B vaccine within 24 hours of birth is 90–95% effective in preventing infection with HBV as well as decreasing HBV transmission if followed by at least two other doses. WHO recommends universal hepatitis B vaccination for all infants and suggests that the first dose be given as soon as possible after birth.[1][2] This strategy has resulted in a dramatic decrease in the prevalence of CHB among young children in regions of the world where universal infant vaccination programs have been implemented. A small proportion of vaccinated children (5–10%) have a poor response to vaccination and remain susceptible to acquisition of HBV infection throughout their lives.[1][3]

The vaccine is highly effective. In endemic countries with high rates of hepatitis B infection, the vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer. This was reported in Taiwan, where the implementation of a nationwide hepatitis B vaccination program in 1984 was associated with a decline in the incidence of childhood hepatocellular carcinoma.[6]

Patients with HIV appear to have inferior antibody responses to hepatitis B vaccination. This is not surprising, as some HIV-positive patients have damaged immune systems; this may happen even before opportunistic infections take hold, thus justifying a diagnosis of AIDS.[7]

Types of Vaccines

The vaccine was originally prepared from plasma obtained from patients with long-standing hepatitis B virus infections. However, currently, they are more commonly made using recombinant DNA technology, though plasma-derived vaccines continue to be used in some places. The two types of vaccines are equally effective and safe.[8]

  • Plasma derived
  • Recombinant DNA
    • Yeast-derived recombinant
    • Mammalian cell-derived recombinant

Licensed hepatitis B vaccines in the United States

Currently licensed hepatitis B vaccines in the United States include:[9]

  • Single-antigen hepatitis B vaccines
    • ENGERIX-B
    • RECOMBIVAX HB
  • Combination vaccines
    • PEDIARIX: Combined hepatitis B, diphtheria, tetanus, acellular pertussis (DTaP), and inactivated poliovirus (IPV) vaccine. Cannot be administered before age 6 weeks or after age 7 years.
    • TWINRIX: Combined hepatitis A and hepatitis B vaccine. Recommended for persons aged ≥18 years who are at increased risk for both Hepatitis A virus and HBV infections.
    • COMVAX (discontinued for purchase as of December 2014): Combined hepatitis B-Haemophilus influenzae type b (Hib) conjugate vaccine. Cannot be administered before age 6 weeks or after age 15 months.

Vaccination recommendation

Hepatitis B vaccination recommendation in Infant and neonates includes:[1]

  • All infants should receive their first dose of hepatitis B vaccine as soon as possible after birth, preferably within 24 hours, followed by two or three additional doses.

Hepatitis B vaccination recommendation in adults include:[9][10]

  • Any person who wants to be protected from HBV infection
  • Patient with diabetes mellitus (age 60 years or older with diabetes mellitus, at the discretion of the treating clinician)
  • Patient with end-stage renal disease, including patients receiving hemodialysis and patients with HIV or chronic liver disease
  • Sexually active and not in a long-term, mutually monogamous relationship (e.g., more than 1 sex partner during the previous 6 months)
  • Seeking evaluation or receiving treatment for a sexually transmitted infection (STI)
  • A male who has sex with males
  • A current or recent injection-drug user
  • At occupational risk of infection through exposure to blood or blood-contaminated body fluids
    • Health care worker
    • Public safety worker
    • Trainee in a health professional or allied health school
  • Residents or staff of an institution for people with developmental disabilities
  • Sexual partners or household members of a person who is chronically infected with HBV (HBsAg-positive)
  • People living in correctional facilities
  • All teenagers ages 18 and younger who are not fully vaccinated
  • People who plan to travel to a country with high or intermediate prevalence of endemic HBV infection
    • Hepatitis B vaccination should be administered to all unvaccinated people traveling to areas with intermediate to high prevalence of chronic hepatitis B (HBV surface antigen prevalence ≥2%)
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Contraindications

Hepatitis B vaccine is contraindicated in a person who has experienced a serious systemic or anaphylactic reaction to a prior dose of the vaccine.

Recommended schedule

The vaccination schedule for children and adults involves 3 intramuscular injections, the second and third doses administered 1 and 6 months after the first.

Recommended doses of hepatitis B vaccines

Recommended doses of hepatitis B vaccines[9]
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Interrupted Vaccination

interruption between doses of hepatitis B vaccination:[9]

  • After the first dose, the second dose should be administered as soon as possible
  • The second and third doses should be separated by an interval of at least 8 weeks
  • If only the third dose is delayed, it should be administered as soon as possible

Booster Doses

Booster doses are not recommended for persons with a normal immune status who were vaccinated as infants, children, or adolescents. Annual antibody to hepatitis B surface antigen testing will determine the need for booster. The booster should be considered when anti-HBs levels decline to <10 mIU/mL should be considered in persons with an ongoing high risk for exposure.[11][12]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 World Health Organization, Guidelines for the Prevention, Care, and Treatment of persons with chronic Hepatitis B Infection. (March 2015). http://apps.who.int/iris/bitstream/10665/154590/1/9789241549059_eng.pdf Accessed on October 4th, 2016
  2. 2.0 2.1 Ni JD, Xiong YZ, Wang XJ, Xiu LC. Does increased hepatitis B vaccination dose lead to a better immune response in HIV- infected patients than standard dose vaccination: a meta-analysis? Int J STD AIDS. 2013;24(2):117–22.
  3. 3.0 3.1 Liu CJ, Liou JM, Chen DS, Chen P J.Natural course and treatment of dual hepatitis B virus and hepatitis C virus infections. J Formos Med Assoc Taiwan. 2005;104(11):783–91.
  4. Mast EE, Weinbaum CM, Fiore AE, Alter MJ, Bell BP, Finelli L; et al. (2006). "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 II: immunization of adults.". MMWR Recomm Rep. 55 (RR-16): 1–33; quiz CE1–4. PMID 17159833. 
  5. US. Preventive Services Task Force. Screening for Hepatitis B infection. (2014) https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/hepatitis-b-virus-infection-screening-2014?ds=1&s=hepatitis%20b Accessed on October 4th, 2016
  6. Chang MH, Chen CJ, Lai MS, Hsu HM, Wu TC, Kong MS, Liang DC, Chau WY, Chen DS (1997). "Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. Taiwan Childhood Hepatoma Study Group". N Engl J Med. 336 (26): 1855–9. PMID 9197213. 
  7. Pasricha N, Datta U, Chawla Y, Singh S, Arora S, Sud A, Minz R, Saikia B, Singh H, James I, Sehgal S (2006). "Immune responses in patients with HIV infection after vaccination with recombinant Hepatitis B virus vaccine". BMC Infect Dis. 6: 65. PMID 16571140. 
  8. Szmuness W, Stevens CE, Harley EJ, Zang EA, Oleszko WR, William DC; et al. (1980). "Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States.". N Engl J Med. 303 (15): 833–41. PMID 6997738. doi:10.1056/NEJM198010093031501. 
  9. 9.0 9.1 9.2 9.3 Centers for Disease Control and Prevention. Hepatitis B (2016) http://www.cdc.gov/hepatitis/hbv/hbvfaq.htm#vaccFAQ Accessed on September 29, 2016
  10. Centers for Disease Control and Prevention. Infectious Diseases Related to Travel. Hepatitis B. (2015) http://wwwnc.cdc.gov/travel/yellowbook/2016/infectious-diseases-related-to-travel/hepatitis-b#4621 Accessed on October 4th, 2016
  11. Morbidity and Mortality Weekly Report. A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. (2006). http://www.cdc.gov/mmwr/PDF/rr/rr5516.pdf Accessed on October 4th, 2016
  12. Centers for Disease Control and Prevention. Prevention and Control of Infections with Hepatitis Viruses in Correctional Settings http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5201a1.htm Accessed on October 4th 2016

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