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Brief Summary

GUIDELINE TITLE

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 1: immunization of infants, children, and adolescents.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Note from the Centers for Disease Control and Prevention (CDC) and the National Guideline Clearinghouse (NGC): On September 19, 2008 the CDC released updated guidelines on hepatitis B. For more information see the NGC summary Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection.

Prevention of Perinatal Hepatitis B Virus (HBV) Infection and Management of Pregnant Women

Prenatal Hepatitis B Surface Antigen (HBsAg) Testing

  • All pregnant women should be tested routinely for HBsAg during an early prenatal visit (e.g., first trimester) in each pregnancy, even if they have been previously vaccinated or tested.
  • Women who were not screened prenatally, those who engage in behaviors that put them at high risk for infection (e.g., injection-drug use, having had more than one sex partner in the previous 6 months or an HBsAg-positive sex partner, evaluation or treatment for a sexually transmitted disease [STD], or recent or current injection-drug use) and those with clinical hepatitis should be tested at the time of admission to the hospital for delivery.
  • All laboratories that provide HBsAg testing of pregnant women should use a U.S. Food and Drug Administration (FDA)-licensed or -approved HbsAg test and should perform testing according to the manufacturer's labeling, including testing of initially reactive specimens with a licensed neutralizing confirmatory test. When pregnant women are tested for HBsAg at the time of admission for delivery, shortened testing protocols may be used and initially reactive results reported to expedite administration of immunoprophylaxis to infants.
  • Women who are HBsAg positive should be referred to an appropriate case-management program to ensure that their infants receive timely postexposure prophylaxis and follow-up (see Case-Management Programs to Prevent Perinatal HBV Infection in the "Description of the Implementation Strategy" field). In addition, a copy of the original laboratory report indicating the pregnant woman's HBsAg status should be provided to the hospital where delivery is planned and to the health-care provider who will care for the newborn.
  • Women who are HBsAg positive should be provided with or referred for appropriate counseling and medical management (see Appendix A in the original guideline document). HBsAg-positive pregnant women should receive information concerning hepatitis B that discusses
    • modes of transmission
    • perinatal concerns (e.g., infants born to HBsAg positive mothers may be breast fed)
    • prevention of HBV transmission to contacts, including the importance of postexposure prophylaxis for the newborn infant and hepatitis B vaccination for household, sexual, and needle-sharing contacts
    • substance abuse treatment, if appropriate; and
    • medical evaluation and possible treatment of chronic hepatitis B
  • When HBsAg testing of pregnant women is not feasible (i.e., in remote areas without access to a laboratory), all infants should receive hepatitis B vaccine <12 hours of birth and should complete the hepatitis B vaccine series according to a recommended schedule for infants born to HBsAg-positive mothers (see Tables 2 and 3 in the original guideline document).

Management of Infants Born to Women Who Are HBsAg Positive

  • All infants born to HBsAg-positive women should receive single-antigen hepatitis B vaccine (see Table 2 in the original guideline document) and hepatitis B immune globulin (HBIG) (0.5 mL) <12 hours of birth, administered at different injection sites. The vaccine series should be completed according to a recommended schedule for infants born to HBsAg-positive mothers (see Table 3 in the original guideline document). The final dose in the vaccine series should not be administered before age 24 weeks (164 days).
  • For preterm infants weighing <2,000 g, the initial vaccine dose (birth dose) should not be counted as part of the vaccine series because of the potentially reduced immunogenicity of hepatitis B vaccine in these infants; 3 additional doses of vaccine (for a total of 4 doses) should be administered beginning when the infant reaches age 1 month (see Tables 3 and 4 in the original guideline document).
  • Postvaccination testing for anti-HBs and HBsAg should be performed after completion of the vaccine series, at age 9-18 months (generally at the next well-child visit). Testing should not be performed before age 9 months to avoid detection of anti-HBs from HBIG administered during infancy and to maximize the likelihood of detecting late HBV infection. Anti-HBc testing of infants is not recommended because passively acquired maternal anti-HBc might be detected in infants born to HBV-infected mothers to age 24 months.
    • HBsAg-negative infants with anti-HBs levels >10 mIU/mL are protected and need no further medical management.
    • HBsAg-negative infants with anti-HBs levels <10 mIU/mL should be revaccinated with a second 3-dose series and retested 1 to 2 months after the final dose of vaccine.
    • Infants who are HBsAg positive should receive appropriate follow-up (see Appendix A in the original guideline document).
  • Infants of HBsAg-positive mothers may be breast fed beginning immediately after birth.
  • Although not indicated in the manufacturer's package labeling, HBsAg-containing combination vaccines may be used for infants aged >6 weeks born to HbsAg-positive mothers to complete the vaccine series after receipt of a birth dose of single-antigen hepatitis B vaccine and HBIG.

Management of Infants Born to Women with Unknown HBsAg Status

  • Women admitted for delivery without documentation of HBsAg test results should have blood drawn and tested as soon as possible after admission.
  • While test results are pending, all infants born to women without documentation of HBsAg test results should receive the first dose of single-antigen hepatitis B vaccine (without HBIG) <12 hours of birth (see Tables 2 and 3 in the original guideline document).
    • If the mother is determined to be HBsAg positive, her infant should receive HBIG as soon as possible but no later than age 7 days, and the vaccine series should be completed according to a recommended schedule for infants born to HBsAg-positive mothers (see Table 3 in the original guideline document).
    • If the mother is determined to be HBsAg negative, the vaccine series should be completed according to a recommended schedule for infants born to HbsAg-negative mothers (see Table 3 in the original guideline document).
    • If the mother has never been tested to determine her HBsAg status, the vaccine series should be completed according to a recommended schedule for infants born to HBsAg-positive mothers (see Table 3 in the original guideline document). Administration of HBIG is not necessary for these infants.
  • Because of the potentially decreased immunogenicity of vaccine in preterm infants weighing <2,000 g, these infants should receive both single-antigen hepatitis B vaccine and HBIG (0.5 mL) if the mother's HBsAg status cannot be determined <12 hours of birth. The birth dose of vaccine should not be counted as part of the 3 doses required to complete the vaccine series; 3 additional doses of vaccine (for a total of 4 doses) should be administered according to a recommended schedule on the basis of the mother's HBsAg test result (see Table 3 in the original guideline document).

Vaccination of Pregnant Women

  • Pregnant women who are identified as being at risk for HBV infection during pregnancy (e.g., having more than one sex partner during the previous 6 months, been evaluated or treated for an STD, recent or current injection-drug use, or having had an HBsAg-positive sex partner) should be vaccinated.
  • Pregnant women at risk for HBV infection during pregnancy should be counseled concerning other methods to prevent HBV infection.

Universal Vaccination of Infants

  • All infants should receive the hepatitis B vaccine series as part of the recommended childhood immunization schedule (see Table 5 and Appendix B in the original guideline document). (For recommendations on management of infants born to HBsAg-positive mothers and infants born to mothers with unknown HBsAg status, see "Prevention of Perinatal HBV Infection and Management of Pregnant Women" section above.)
  • For all medically stable infants weighing >2,000 g at birth and born to HBsAg-negative mothers, the first dose of vaccine should be administered before hospital discharge. Only single-antigen hepatitis B vaccine should be used for the birth dose.
  • On a case-by-case basis and only in rare circumstances, the first dose may be delayed until after hospital discharge for an infant who weighs >2,000 g and whose mother is HBsAg negative.
    • When such a decision is made, a physician's order to withhold the birth dose and a copy of the original laboratory report indicating that the mother was HBsAg negative during this pregnancy should be placed in the infant's medical record.
    • For infants who do not receive a first dose before hospital discharge, the first dose should be administered no later than age 2 months.
    • Situations in which the birth dose should not be delayed include any high-risk sexual or drug-using practices of the infant's mother during pregnancy (e.g., having had more than one sex partner during the previous 6 months or an HBsAg-positive sex partner, evaluation or treatment for an STD, or recent or current injection-drug use) and expected poor compliance with follow-up to initiate the vaccine series.
  • Preterm infants weighing <2,000 g and born to HBsAg-negative mothers should have their first vaccine dose delayed until 1 month after birth or hospital discharge (see Table 4 in the original guideline document). For these infants, a copy of the original laboratory report indicating that the mother was HBsAg-negative during this pregnancy should be placed in the infant's medical record.
  • The vaccine series should be completed according to a recommended schedule with either single-antigen vaccine or a combination vaccine that contains the hepatitis B vaccine antigen (e.g., Haemophilus influenzae type b [Hib]-hepatitis B or diphtheria and tetanus toxoids and acellular pertussis adsorbed inactivated poliovirus [DtaP-IPV]-hepatitis B) (see Table 2 in the original guideline document). The final dose in the vaccine series should not be administered before age 24 weeks (164 days).
  • Administration of 4 doses of hepatitis B vaccine to infants is permissible in certain situations (e.g., when combination vaccines are administered after the birth dose).
  • In populations with currently or previously high rates of childhood HBV infection (i.e., Alaska Natives; Pacific Islanders; and immigrant families from Asia, Africa, and other regions with intermediate or high endemic rates of infection [see Figure 1 and Box 2 in the original guideline document]), the first dose of hepatitis B vaccine should be administered at birth and the final dose at age 6 to 12 months.

Vaccination of Children and Adolescents Who Were Not Previously Vaccinated

  • Hepatitis B vaccination is recommended for all children and adolescents aged <19 years.
  • Children and adolescents who have not previously received hepatitis B vaccine should be vaccinated routinely at any age with an appropriate dose and schedule (see Tables 2 and 5 in the original guideline document). Selection of a vaccine schedule should consider the need to achieve completion of the vaccine series. In all settings, vaccination should be initiated even though completion of the vaccine series might not be ensured.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated for each recommendation.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2005 Dec 23

GUIDELINE DEVELOPER(S)

Centers for Disease Control and Prevention - Federal Government Agency [U.S.]

SOURCE(S) OF FUNDING

United States Government

GUIDELINE COMMITTEE

Advisory Committee on Immunization Practices (ACIP)
Advisory Committee on Immunization Practices ACIP Hepatitis Vaccines Working Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Prepared by: Eric E. Mast, MD, Division of Viral Hepatitis, National Center for Infectious Diseases; Harold S. Margolis, MD, Division of Viral Hepatitis, National Center for Infectious Diseases; Anthony E. Fiore, MD, Division of Viral Hepatitis, National Center for Infectious Diseases; Edward W. Brink, MD, Immunization Services Division, National Immunization Program; Susan T. Goldstein, MD, Division of Viral Hepatitis, National Center for Infectious Diseases; Susan A. Wang, MD, Division of Viral Hepatitis, National Center for Infectious Diseases; Linda A. Moyer, Division of Viral Hepatitis, National Center for Infectious Diseases; Beth P. Bell, MD, Division of Viral Hepatitis, National Center for Infectious Diseases; Miriam J. Alter, PhD Division of Viral Hepatitis, National Center for Infectious Diseases

Advisory Committee on Immunization Practices (ACIP) Membership List, June 2005: Myron J. Levin, MD (Chairman) Professor of Pediatrics and Medicine, University of Colorado Health Sciences Center, Denver, Colorado; Larry Pickering, MD (Executive Secretary) National Immunization Program, CDC, Atlanta, Georgia; Jon S. Abramson, MD, Wake Forest University School of Medicine, Winston-Salem, North Carolina; Ban Mishu Allos, MD, Vanderbilt University School of Medicine, Nashville, Tennessee; Guthrie S. Birkhead, MD, New York State Department of Health, Albany, New York; Judith Campbell, MD, Baylor College of Medicine, Houston, Texas; Reginald Finger, MD, Focus on the Family, Colorado Springs, Colorado; Janet Gildsdorf, MD, University of Michigan, Ann Arbor, Michigan; Tracy Lieu, MD, Harvard Pilgrim Health Care and Harvard Medical School, Boston, Massachusetts; Edgar Marcuse, MD, Children's Hospital and Regional Medical Center, Seattle, Washington; Julia Morita, MD, Chicago Department of Health, Chicago, Illinois; Gregory Poland, MD, Mayo Clinic College of Medicine, Rochester, Minnesota; John B. Salamone, National Italian American Foundation, Washington, DC; Patricia Stinchfield, Children's Hospital and Clinics, St. Paul, Minnesota; John J. Treanor, MD, University of Rochester School of Medicine and Dentistry, Rochester, New York; Robin Womeodu, MD, University of Tennessee Health Sciences Center, Memphis, Tennessee

Ex-Officio Members: James E. Cheek, MD, Indian Health Service, Albuquerque, New Mexico; Wayne Hachey, DO, Department of Defense, Falls Church, Virginia; Geoffrey S. Evans, MD, Health Resources and Services Administration, Rockville, Maryland; Bruce Gellin, MD, National Vaccine Program Office, Washington, DC; Linda Murphy, Centers for Medicare and Medicaid Services, Baltimore, Maryland; George T. Curlin, MD, National Institutes of Health, Bethesda, Maryland; Norman Baylor, MD, Food and Drug Administration, Bethesda, Maryland; Kristin Lee Nichol, MD, Department of Veterans Affairs, Minneapolis, Minnesota

Liaison Representatives: American Academy of Family Physicians, Jonathan Temte, MD, Clarence, New York, and Richard Clover, MD, Louisville, Kentucky; American Academy of Pediatrics, Margaret Rennels, MD, Baltimore, Maryland, and Carol Baker, MD, Houston, Texas; America's Health Insurance Plans, Andrea Gelzer, MD, Hartford, Connecticut; American College Health Association, James C. Turner, MD, Charlottesville, Virginia; American College of Obstetricians and Gynecologists, Stanley Gall, MD, Louisville, Kentucky; American College of Physicians, Kathleen Neuzil, MD, Seattle, Washington; American Medical Association, Litjen Tan, PhD, Chicago, Illinois; American Pharmacists Association, Stephan L. Foster, PharmD, Memphis, Tennessee; Association of Teachers of Preventive Medicine, W. Paul McKinney, MD, Louisville, Kentucky; Biotechnology Industry Organization, Clement Lewin, PhD, Cambridge, Massachusetts; Canadian National Advisory Committee on Immunization, Monica Naus, MD, Vancouver, British Columbia; Health-Care Infection Control Practices Advisory Committee, Steve Gordon, MD, Cleveland, Ohio; Infectious Diseases Society of America, Samuel L. Katz, MD, Durham, North Carolina, and William Schaffner, MD, Nashville, Tennessee; London Department of Health, David M. Salisbury, MD, London, United Kingdom; National Association of County and City Health Officials, Nancy Bennett, MD, Rochester, New York; National Coalition for Adult Immunization, David A. Neumann, PhD, Bethesda, Maryland; National Immunization Council and Child Health Program, Mexico, Romeo Rodriguez, Mexico City, Mexico; National Medical Association, Dennis A. Brooks, MD, Baltimore, Maryland; National Vaccine Advisory Committee, Charles Helms, MD, PhD, Iowa City, Iowa; Pharmaceutical Research and Manufacturers of America, Damian A. Braga, Swiftwater, Pennsylvania, and Peter Paradiso, PhD, Collegeville, Pennsylvania; and Society for Adolescent Medicine, Amy Middleman, MD, Houston, Texas

Advisory Committee on Immunization Practices (ACIP) Hepatitis Vaccines Working Group Members: Tracy Lieu, MD (Chairman) Boston, Massachusetts; Jon Abramson, MD, Winston-Salem, North Carolina; Beth Bell, MD, Atlanta, Georgia; James E. Cheek, MD, Albuquerque, New Mexico; Anthony Fiore, MD, Atlanta, Georgia; Stephen Feinstone, MD, Bethesda, Maryland; Robert Frenck, MD, Torrance, California; Stanley Gall, MD, Louisville, Kentucky; Janet Gildsdorf, MD, Ann Arbor, Michigan; Steve Gordon, MD, Cleveland, Ohio; Samuel L. Katz, MD, Durham, North Carolina; Edgar Marcuse, MD, Seattle, Washington; Ban Mishu Allos, MD, Nashville, Tennessee; Eric Mast, MD, Atlanta, Georgia; Julia Morita, MD, Chicago, Illinois; William Schaffner, MD, Nashville, Tennessee; Deborah Wexler, MD, Minneapolis, Minnesota

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Centers for Disease Control and Prevention (CDC), their planners, and content experts wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. Presentations will not include any discussion of the unlabeled use of a product or a product under investigational use.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available from the Centers for Disease Control and Prevention (CDC) Web site:

Print copies: Available from the Centers for Disease Control and Prevention, MMWR, Atlanta, GA 30333. Additional copies can be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325; (202) 783-3238.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on February 21, 2006.

COPYRIGHT STATEMENT

No copyright restrictions apply.

DISCLAIMER

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