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Hepatitis B Vaccination

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Effective hepatitis B vaccine have been available since the early 1980s and should be used whenever possible and when not contraindicated. Contraindications include serious allergic reaction to a prior dose of hepatitis B vaccine, to a component of the hepatitis B vaccine, or baking yeast.

Contents

Who Should Get Vaccinated

The Advisory Committee on Immunization Practices recommends that the following persons be vaccinated against hepatitis B:

  • All infants, beginning at birth.
  • All children aged less than 19 years who have not been previously vaccinated.
  • Susceptible sex partners of people who are positive for hepatitis B surface antigen (HBsAg).
  • Sexually active persons who are not in a long-term, mutually monogamous relationship (e.g., more than one sex partner during the previous six months)
  • People seeking evaluation or treatment for a sexually transmitted disease.
  • Men who have sex with men (MSM).
  • Injection drug users.
  • Susceptible household contacts of HBsAg-positive people.
  • Healthcare and public safety workers at risk for exposure to blood or blood-contaminated body fluids.
  • People with end-stage renal disease, including predialysis, hemodialysis, peritoneal dialysis, and home dialysis patients.
  • Residents and staff of facilities for developmentally disabled persons.
  • Travelers to regions with intermediate or high rates of endemic HBV infection.[1]
  • People with chronic liver disease.
  • People with HIV infection.
  • All other people seeking protection from HBV infection. Such people do not need to acknowledge any specific risk factor to be vaccinated. It is enough to simply desire protection from Hepatitis B infection.

In certain healthcare, evaluation, or treatment settings, a high proportion of clients have known risk factors for HBV infection. The Advisory Committee on Immunization Practices recommends universal vaccination of adults who receive care in those settings, including:

  • Sexually transmitted disease treatment facilities.
  • HIV testing and treatment facilities.
  • Facilities providing drug-abuse treatment and prevention services.
  • Health-care settings targeting services to injection-drug users.
  • Correctional facilities.
  • Health-care settings targeting services to men who have sex with men (MSM).
  • Chronic hemodialysis facilities and end-stage renal disease programs.
  • Institutions and nonresidential day care facilities for developmentally disabled people.

Testing Before Vaccination

Historically, routine prevaccination testing was not recommended because it was not found to be cost-effective. However, with the availability of antiviral agents to treat chronic HBV infection, new recommendations for identifying people with chronic HBV infection are being developed. CDC currently recommends that certain populations undergo testing for HBV infection, including

  • Hemodialysis patients
  • Pregnant women
  • People with known or suspected exposure to HBV including:
    • Infants born to HBV-infected mothers
    • Household contacts of HBV-infected people
    • People with known occupational or other exposures to infectious blood or body fluids
  • Foreign-born persons from countries of high endemic rates of HBV
  • HIV-positive people

For these populations, blood tests for HBsAg and anti-HBs need to be used to determine infection or immunity prior to vaccination.

The vaccination schedule most often used for children and adults is three intramuscular injections. The second and third doses are administered 1 and 6 months, respectively, after the first dose. Alternate schedules have been approved for certain vaccines and/or populations.

! colspan="12" valign="top" | Recommended doses of currently licensed formulations of hepatitis B vaccine,
by age group and vaccine type
Age Group Single-antigen vaccine Combination vaccine
Recombivax HB Engerix-B Comvaxa Pediarixb Twinrixc
Dose
(μg)
Vol(mL) Dose
(μg)
Vol(mL) Dose
(μg)
Vol (mL) Dose
(μg)
Vol (mL) Dose
(μg)
Vol (mL)
Infants (<1 yr) 5 0.5 10 0.5 5 0.5 10 0.5 NA** NA
Children (1-10 yrs) 5 0.5 10 0.5 5* 0.5 10 0.5 NA NA
Adolescents 11-15 yrs 10 1.0 NA NA NA NA NA NA NA NA
11-19 yrs 5 0.5 10 0.5 NA NA NA NA NA NA
Adults (≥20 yrs) 10 1.0 20 1.0 NA NA NA NA 20§ 1.0
Hemodialysis patients
and other immuno-
compromised persons
<20 yrs§§ 5 0.5 10 0.5 NA NA NA NA NA NA
≥20 yrs 40¶¶ 1.0 40*** 2.0 NA NA NA NA NA NA

a Combined hepatitis B/Haemophilus influenzae type b conjugate vaccine. This vaccine cannot be administered at birth, before age 6 weeks, or after age 71 months.

b Combined hepatitis B, diphtheria, tetanus, acellular pertussis adsorbed, inactivated poliovirus vaccine. This vaccine cannot be administered at birth, before age 6 weeks, or at age >7 years.

c Combined hepatitis A and hepatitis B vaccine. This vaccine is recommended for persons aged ≥18 years who are at increased risk for both hepatitis B virus and hepatitis A virus infections.

Recombinant hepatitis B surface antigen protein dose.

¶¶ Dialysis formulation administered on a 3-dose schedule at 0, 1, and 6 months.

** Not applicable.

*** Two 1.0-mL doses administered at one site, on a 4-dose schedule at 0, 1, 2, and 6 months.

§ Adult formulation administered on a 2-dose schedule.

§§ Higher doses might be more immunogenic, but no specific recommendations have been made.


Different doses of vaccine do not have to be from the same manufacturer. If the second or third dose is missed after the first vaccination, the whole series does not have to be restarted:

  • If the vaccine series was interrupted 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.

There is no danger or harm if the series is repeated or any of the doses are repeated. This can be done together with other vaccines, but separate body sites and syringes need to be used.

Recent studies indicate that immunologic memory remains intact for at least 23 years and confers protection against clinical illness and chronic hepatitis B virus infection. Cellular immunity appears to persist even though antibody levels might become low or decline below detectable levels.[2][3]

Vaccination and Pregnancy

Hepatitis B vaccine contains no live virus, so both pregnant and lactating women can receive the vaccine. On the basis of limited experience, there is no apparent risk of adverse effects to developing fetuses when hepatitis B vaccine is administered to pregnant women. However, new HBV infection in a pregnant woman can be serious and can result in severe disease for the mother and chronic infection for the newborn.[4]

Vaccination and Newborns

Infants born to HBV-infected mothers require hepatitis B vaccine and hepatitis B immune globulin (HBIG) within 12 hours of birth to protect them from infection. However, errors or delays in documenting, testing, and reporting maternal HBsAg status can and do occur. Administering the first dose of hepatitis B vaccine soon after birth to all infants acts as a safety net. This reduces the risk for perinatal infection in the baby when the mother's HBsAg status is either unknown or incorrectly documented at delivery. Also, initiating the hepatitis B vaccine series at birth has been shown to increase a child's likelihood of completing the vaccine series on schedule. [5]

Vaccination in the Immunocompromised

A larger vaccine dose is required to induce protective antibody in hemodialysis patients. Larger doses or additional doses might also be necessary for other immunocompromised persons. Blood testing of hemodialysis patients and other immunocompromised people is recommended 1-2 months after the final dose of the primary vaccine series to determine the need for revaccination. [6]

Vaccination After Exposure to HBV

After a person has been exposed to HBV, a vaccine should be given as soon as possible but preferably within 24 hours. This can effectively prevent infection. The mainstay of post exposure prevention is hepatitis B vaccine. In certain circumstances the addition of HBIG (hepatitis B immunoglobulin) provides increased protection.

Postvaccination Testing

Testing for immunity is advised only for people whose subsequent clinical management depends on knowledge of their immune status, including:

  • Infants born to HBsAg-positive mothers
  • Healthcare workers and public safety workers at high risk for exposure to blood or body fluids
  • Chronic hemodialysis patients, HIV-infected persons, and other immunocompromised persons (e.g., hematopoietic stem-cell transplant recipients or people receiving chemotherapy)
  • Sex partners of people with chronic HBV infection

When necessary, postvaccination testing for antibodies to hepatitis B surface antigen (anti-HBs) should generally be performed 1-2 months after completion of the vaccine series.

For infants born to HBsAg-positive mothers, postvaccination testing should be performed 1-2 months after completion of three or more doses of a licensed hepatitis B vaccine series. To avoid detection of anti-HBs from hepatitis B immune globulin administered during infancy and to maximize detection of late HBV infection, testing should not be performed before age 9 months nor within 4 weeks of the most recent vaccine dose.

Booster Doses

Booster doses of hepatitis B vaccine are recommended only in certain circumstances:

  • For hemodialysis patients, the need for booster doses should be assessed by annual testing for antibody to hepatitis B surface antigen (anti-HBs). A booster dose needs to be administered when anti-HBs levels decline to less than 10 mIU/mL.
  • For other immunocompromised persons (e.g., HIV-infected persons, hematopoietic stem-cell transplant recipients, and people receiving chemotherapy), the need for booster doses has not been determined. When anti-HBs levels decline to less than 10 mIU/mL, annual anti-HBs testing and booster doses should be considered for those with an ongoing risk for exposure.

For people with normal immune status who have been vaccinated, booster doses are not recommended.

References

  1. CDC Traveler's Recomendation. Hepatitis B CDC
  2. van der Sande MA, Waight PA, Mendy M, Zaman S, et al. Long-term protection against HBV chronic carriage of Gambian adolescents vaccinated in infancy and immune response in HBV booster trial in adolescence. PLoS ONE. 2007 Aug 15;2(1):e753. Full Text
  3. Chen DS. Long-term protection of hepatitis B vaccine: lessons from Alaskan experience after 15 years. Ann Intern Med. 2005 Mar 1;142(5):384-5. Full Text PDF
  4. Gambarin-Gelwan M. Hepatitis B in pregnancy. Clin Liver Dis. 2007 Nov;11(4):945-63. Abstract
  5. Velu V, Nandakumar S, Shanmugam S, et al. Comparison of three different recombinant hepatitis B vaccines: GeneVac-B, Engerix B and Shanvac B in high risk infants born to HBsAg positive mothers in India. World J Gastroenterol. 2007 Jun 14;13(22):3084-9. Full Text PDF
  6. Advisory Committee on Immunization Practices PDF

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