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Table 1.  

HBsAg Total anti-HBc IgM anti-HBc Anti-HBs HBV DNA Interpretation
Never infected
+ + or – Early acute infection; transient (up to 18 days) after vaccination
+ + + + Acute infection
+ + + or – + or – Acute resolving infection
+ + Recovered from past infection and immune
+ + + Chronic infection
+ + or – False-positive (i.e., susceptible); past infection; “low-level” chronic infection; or passive transfer of anti-HBc to infant born to HBsAg-positive mother
+ Immune if anti-HBs concentration is ≥10 mIU/mL after vaccine series completion; passive transfer after hepatitis B immune globulin administration

Table 1. Typical interpretation of test results for hepatitis B virus infection

Abbreviations: – = negative; + = positive; anti-HBc = antibody to hepatitis B core antigen; anti-HBs = antibody to hepatitis B surface antigen; HBsAg = hepatitis B surface antigen; HBV DNA = hepatitis B virus deoxyribonucleic acid; IgM = immunoglobulin class M.

Table 2.  

Age group (yrs) Single-antigen vaccine Combination vaccine
Recombivax Engerix Pediarix* Twinrix
Dose (µg) Vol (mL) Dose (µg) Vol (mL) Dose (µg) Vol (mL) Dose (µg) Vol (mL)
Birth–10 5 0.5 10 0.5 10* 0.5 N/A N/A
11–15 10§ 1 N/A N/A N/A N/A N/A N/A
11–19 5 0.5 10 0.5 N/A N/A N/A N/A
≥20 10 1 20 1 N/A N/A 20 1
Hemodialysis patients and other immune-compromised persons
<20 5 0.5 10 0.5 N/A N/A N/A N/A
≥20 40 1 40 2 N/A N/A N/A N/A

Table 2. Recommended doses of hepatitis B vaccine, by group and vaccine type

Abbreviation: N/A = not applicable.
* Pediarix is approved for use in persons aged 6 weeks through 6 years (prior to the 7th birthday).
Twinrix is approved for use in persons aged ≥18 years.
§ Adult formulation administered on a 2-dose schedule.

Table 3.  

Birthweight Maternal HBsAg status Single-antigen vaccine Single-antigen + combination vaccine
Dose Age Dose Age
≥2,000 g Positive 1 Birth (≤12 hrs) 1 Birth (≤12 hrs)
HBIG§ Birth (≤12 hrs) HBIG Birth (≤12 hrs)
2 1–2 mos 2 2 mos
3 6 mos 3 4 mos
4 6 mos
Unknown* 1 Birth (≤12 hrs) 1 Birth (≤12 hrs)
2 1–2 mos 2 2 mos
3 6 mos 3 4 mos
4 6 mos
Negative 1 Birth (≤24 hrs) 1 Birth (≤24 hrs)
2 1–2 mos 2 2 mos
3 6–18 mos 3 4 mos
4 6 mos
<2,000 g Positive 1 Birth (≤12 hrs) 1 Birth (≤12 hrs)
HBIG Birth (≤12 hrs) HBIG Birth (≤12 hrs)
2 1 mos 2 2 mos
3 2–3 mos 3 4 mos
4 6 mos 4 6 mos
Unknown 1 Birth (≤12 hrs) 1 Birth (≤12 hrs)
HBIG Birth (≤12 hrs) HBIG Birth (≤12 hrs)
2 1 mos 2 2 mos
3 2–3 mos 3 4 mos
4 6 mos 4 6 mos
Negative 1 Hospital discharge or age 1 mo 1 Hospital discharge or age 1 mo
2 2 mos 2 2 mos
3 6–18 mos 3 4 mos
4 6 mos

Table 3. Hepatitis B vaccine schedules for infants, by infant birthweight and maternal HBsAg status

Abbreviations: HBIG = hepatitis B immune globulin; HBsAg = hepatitis B surface antigen.
* Mothers should have blood drawn and tested for HBsAg as soon as possible after admission for delivery; if the mother is found to be HBsAg positive, the infant should receive HBIG as soon as possible but no later than age 7 days.
Pediarix should not be administered before age 6 weeks.
§ HBIG should be administered at a separate anatomical site from vaccine.
The final dose in the vaccine series should not be administered before age 24 weeks (164 days).

Table 4.  

Age group Schedule* (interval represents time in months from first dose)
Children (1–10 yrs) 0, 1, and 6 mos
0, 1, 2, and 12 mos
Adolescents (11–19 yrs) 0, 1, and 6 mos
0, 12, and 24 mos
0 and 4–6 mos
0, 1, 2, and 12 mos
0, 7 days, 21–30 days, 12 mos§
Adults (≥20 yrs) 0, 1, and 6 mos
0, 1, 2, and 12 mos
0, 1, 2, and 6 mos
0, 7 days, 21–30 days, 12 mos§

Table 4. Hepatitis B vaccine schedules for children, adolescents, and adults

* Refer to package inserts for further information. For all ages, when the HepB vaccine schedule is interrupted, the vaccine series does not need to be restarted. If the series is interrupted after the first dose, the second dose should be administered as soon as possible, and the second and third doses should be separated by an interval of at least 8 weeks. If only the third dose has been delayed, it should be administered as soon as possible. The final dose of vaccine must be administered at least 8 weeks after the second dose and should follow the first dose by at least 16 weeks; the minimum interval between the first and second doses is 4 weeks. Inadequate doses of hepatitis B vaccine or doses received after a shorter-than-recommended dosing interval should be readministered, using the correct dosage or schedule. Vaccine doses administered ≤4 days before the minimum interval or age are considered valid. Because of the unique accelerated schedule for Twinrix, the 4-day guideline does not apply to the first three doses of this vaccine when administered on a 0-day, 7-day, 21–30-day, and 12-month schedule (new recommendation).
A 2-dose schedule of Recombivax adult formulation (10 µg) is licensed for adolescents aged 11–15 years. When scheduled to receive the second dose, adolescents aged >15 years should be switched to a 3-dose series, with doses 2 and 3 consisting of the pediatric formulation administered on an appropriate schedule.
§ Twinrix is approved for use in persons aged ≥18 years and is available on an accelerated schedule with doses administered at 0, 7, 21–30 days, and 12 months.
A 4-dose schedule of Engerix administered in two 1 mL doses (40 µg) on a 0-, 1-, 2-, and 6-month schedule is recommended for adult hemodialysis patients.

Table 5.  

HCP status Postexposure testing Postexposure prophylaxis Postvaccination serologic testing
Source patient (HBsAg) HCP testing (anti-HBs) HBIG Vaccination
Documented responder after complete series     No action needed    
Documented nonresponder after two complete series Positive/unknown * HBIG x2 separated by 1 month N/A
Negative     No action needed  
Response unknown after complete series Positive/unknown <10 mIU/mL HBIG x1 Initiate revaccination Yes
Negative <10 mIU/mL None    
Any result <10  mIU/mL   No action needed  
Unvaccinated/incompletely vaccinated or vaccine refusers Positive/unknown HBIG x1 Complete vaccination Yes
Negative None Complete vaccination Yes

Table 5. Postexposure management of health care personnel after occupational percutaneous or mucosal exposure to blood or body fluids, by health care personnel HepB vaccination and response status

Abbreviations: anti HBs = antibody to hepatitis B surface antigen; HBIG = hepatitis B immune globulin; HBsAg = hepatitis B surface antigen; HCP = health care personnel; N/A = not applicable.
* Not indicated.

Table 6.  

Exposure* Management
Unvaccinated person Previously vaccinated person
HBsAg-positive source HepB vaccine series and HBIG HepB vaccine dose
HBsAg status unknown for source Hep B vaccine series No management

Table 6. Postexposure management after distinct nonoccupational percutaneous or mucosal exposure to blood or body fluids

Abbreviations: HepB = hepatitis B; HBsAg = hepatitis B surface antigen; HBIG = hepatitis B immune globulin.
* Exposures include percutaneous (e.g., bite or needlestick) or mucosal exposure to blood or body fluids, sex or needle-sharing contact, or victim of sexual assault/abuse.

Box 1.  

AASLD American Association for the Study of Liver Diseases
ACIP Advisory Committee on Immunization Practices
anti-HBc antibody to hepatitis B core antigen
anti-HBe antibody to hepatitis B e antigen
anti-HBs antibody to hepatitis B surface antigen
HBeAg hepatitis B e antigen
HBIG hepatitis B immune globulin
HBsAg hepatitis B surface antigen
HBV hepatitis B virus
HBV DNA hepatitis B virus deoxyribonucleic acid
HCP health care personnel
HCV hepatitis C virus
HepB hepatitis B
HIV human immunodeficiency virus
IDSA Infectious Diseases Society of America
IDU Injection-drug use
IgM Immunoglobulin class M
IgG Immunoglobulin class G
MSM men who have sex with men
NNDSS National Notifiable Diseases Surveillance System
PHBPP Perinatal Hepatitis B Prevention Program
PWID persons who inject drugs
QALY quality-adjusted life-year
STI sexually transmitted infection
VAERS Vaccine Adverse Events Reporting System
VSD Vaccine Safety Datalink

Box 1. Abbreviations used in this report

Box 2.  

  • Screening of all pregnant women for HBsAg
    • --HBV DNA testing for HBsAg-positive pregnant women, with suggestion of maternal antiviral therapy to reduce perinatal transmission when HBV DNA is >200,000 IU/mL
    • --Prophylaxis (HepB vaccine and HBIG) for infants born to HBsAg-positive women
  • Universal vaccination of all infants beginning at birth§,¶ as a safeguard for infants born to HBV-infected mothers not identified prenatally
  • Routine vaccination of previously unvaccinated children aged <19 years
  • Vaccination of adults at risk for HBV infection, including those requesting protection from HBV without acknowledgment of a specific risk factor

Box 2. Strategy to eliminate HBV transmission in the United States*

*Sources: Mast EE, Margolis HS, Fiore AE, et al. 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. MMWR Recomm Rep 2005;54(No. RR-16):1–31; Mast EE, Weinbaum CM, Fiore AE, et al. 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 2006;55(No. RR-16):1–33.
Refer to Table 3 for prophylaxis recommendations for infants born to women with unknown HBsAg status.
§Within 24 hours of birth for medically stable infants weighing ≥2,000 grams.
Refer to Table 3 for birth dose recommendations for infants weighing <2,000 grams.

Box 3.  

High (≥8% prevalence): Angola, Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Congo, Côte d’Ivoire, Djibouti, Equatorial Guinea, Gabon, Gambia, Ghana, Guinea, Haiti, Kiribati, Kyrgyzstan, Laos, Liberia, Malawi, Mali, Mauritania, Mongolia, Mozambique, Namibia, Nauru, Niger, Nigeria, Niue, Papua New Guinea, Senegal, Sierra Leone, Solomon Islands, Somalia, South Sudan, Sudan, Swaziland, Togo, Tonga, Uganda, Vanuatu, Vietnam, Yemen, and Zimbabwe.

Intermediate (5%–7.9% prevalence): Albania, Bhutan, Cape Verde, China, Democratic Republic of the Congo, Ethiopia, Kazakhstan, Kenya, Marshall Islands, Moldova, Oman, Romania, Rwanda, Samoa, South Africa, Tajikistan, Tanzania, Thailand, Tunisia, Tuvalu, Uzbekistan, and Zambia

Low Intermediate (2%–4.9% prevalence): Algeria, Azerbaijan, Bangladesh, Belarus, Belize, Brunei Darussalam, Bulgaria, Cambodia, Colombia, Cyprus, Dominican Republic, Ecuador, Eritrea, Federated States of Micronesia, Fiji, Georgia, Italy, Jamaica, Kosovo, Libya, Madagascar, Myanmar, New Zealand, Pakistan, Palau, Philippines, Peru, Russia, Saudi Arabia, Singapore, South Korea, Sri Lanka, Suriname, Syria, Tahiti, and Turkey.

Low (≤1.9% prevalence): Afghanistan, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Nepal, Netherlands, Nicaragua, Norway, Palestine, Panama, Poland, Portugal, Qatar, Serbia, Seychelles, Slovakia, Slovenia, Spain, Sweden, Switzerland, Ukraine, UK, United Arab Emirates, United States of America, and Venezuela.

No data: Andorra, Antigua and Barbuda, Armenia, The Bahamas, Botswana, Chad, Comoros, Cook Islands, Dominica, El Salvador, Finland, Grenada, Guinea- Bissau, Guyana, Honduras, Latvia, Lesotho, Lithuania, Luxembourg, Macedonia, Maldives, Malta, Mauritius, Monaco, Montenegro, North Korea, Paraguay, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, San Marino, Sao Tome and Principe, Timor-Leste, Trinidad and Tobago, Turkmenistan, and Uruguay.

Box 3. Prevalence of chronic hepatitis B virus infection, by country*

* Source: CDC. Travelers health: infectious diseases related to travel. Atlanta, GA: US Department of Health and Human Services, CDC; 2017.

Box 4.  

  • All infants
  • Unvaccinated children aged <19 years
  • Persons at risk for infection by sexual exposure
    • --Sex partners of hepatitis B surface antigen (HBsAg)–positive persons
    • --Sexually active persons who are not in a long-term, mutually monogamous relationship (e.g., persons with more than one sex partner during the previous 6 months)
    • --Persons seeking evaluation or treatment for a sexually transmitted infection
    • --Men who have sex with men
  • Persons at risk for infection by percutaneous or mucosal exposure to blood
    • --Current or recent injection-drug users
    • --Household contacts of HBsAg-positive persons
    • --Residents and staff of facilities for developmentally disabled persons
    • --Health care and public safety personnel with reasonably anticipated risk for exposure to blood or blood-contaminated body fluids
    • --Hemodialysis patients and predialysis, peritoneal dialysis, and home dialysis patients
    • --Persons with diabetes aged 19–59 years; persons with diabetes aged ≥60 years at the discretion of the treating clinician
  • Others
    • --International travelers to countries with high or intermediate levels of endemic hepatitis B virus (HBV) infection (HBsAg prevalence of ≥2%)
    • --Persons with hepatitis C virus infection
    • --Persons with chronic liver disease (including, but not limited to, persons with cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine aminotransferase [ALT] or aspartate aminotransferase [AST] level greater than twice the upper limit of normal)
    • --Persons with HIV infection
    • --Incarcerated persons
    • --All other persons seeking protection from HBV infection

Box 4. Persons recommended to receive hepatitis B vaccination

Box 5.  

The issue: An increasing number of HCP have received routine hepatitis B (HepB) vaccination during childhood. No postvaccination serologic testing is recommended after routine infant or adolescent HepB vaccination. Because vaccine-induced antibody to hepatitis B surface antigen (anti-HBs) wanes over time, testing HCP for anti-HBs years after vaccination might not distinguish vaccine nonresponders from responders.

Guidance for health care institutions: Health care institutions may measure anti-HBs upon hire or matriculation for HCP who have documentation of a complete HepB vaccine series in the past (e.g., as part of routine infant or adolescent vaccination). HCP with anti-HBs <10 mIU/mL should receive one or more additional doses of HepB vaccine and retesting (Figure 3). Institutions that decide to not measure anti-HBs upon hire or matriculation for HCP who have documentation of a complete HepB vaccine series in the past should ensure timely assessment and postexposure prophylaxis following an exposure (Table 5).

Considerations: The risk for occupational HBV infection for vaccinated HCP might be low enough in certain settings so that assessment of anti-HBs status and appropriate follow-up should be done at the time of exposure to potentially infectious blood or body fluids. This approach relies on HCP recognizing and reporting blood and body fluid exposures and therefore may be applied on the basis of documented low risk, implementation, and cost considerations. Certain HCP occupations have lower risk for occupational blood and body fluid exposures (e.g., occupations involving counseling versus performing procedures), and nontrainees have lower risks for blood and body fluid exposures than trainees. Some settings also will have a lower prevalence of HBV infection in the patient population served than in other settings, which will influence the risk for HCP exposure to HBsAg-positive blood and body fluids.

Box 5. Testing anti-HBs for health care personnel (HCP) vaccinated in the past

Box 6.  

  • Household, sexual, or needle contacts of hepatitis B surface antigen (HBsAg)–positive persons
  • HIV-positive persons
  • Persons with elevated alanine aminotransferase/aspartate aminotransferase of unknown etiology
  • Hemodialysis patients
  • Men who have sex with men
  • Past or current persons who inject drugs
  • Persons born in countries of high and intermediate hepatitis B virus (HBV) endemicity (HBsAg prevalence ≥2%)
  • U.S.-born persons not vaccinated as infants whose parents were born in countries with high HBV endemicity (≥8%)
  • Persons needing immunosuppressive therapy, including chemotherapy, immunosuppression related to organ transplantation, and immunosuppression for rheumatologic or gastroenterologic disorders
  • Donors of blood, plasma, organs, tissues, or semen

Box 6. Persons recommended to receive serologic testing prior to vaccination*

* Serologic testing comprises testing for hepatitis B surface antigen (HBsAg), antibody to HBsAg, and antibody to hepatitis B core antigen.
Denotes persons also recommended for hepatitis B vaccination. Serologic testing should occur prior to vaccination. Serologic testing should not be a barrier to vaccination of susceptible persons. The first dose of vaccine should typically be administered immediately after collection of the blood for serologic testing.

Box 7.  

  • Infants born to hepatitis B surface antigen (HBsAg)–positive mothers or mothers whose HBsAg status remains unknown (e.g., when a parent or person with lawful custody safely surrenders an infant confidentially shortly after birth infants safely surrendered at or shortly after birth)
  • Health care personnel and public safety workers
  • Hemodialysis patients and others who might require outpatient hemodialysis (e.g., predialysis, peritoneal dialysis, and home dialysis)
  • HIV-infected persons
  • Other immunocompromised persons (e.g., hematopoietic stem-cell transplant recipients or persons receiving chemotherapy)
  • Sex partners of HBsAg-positive persons

Box 7. Persons recommended to receive postvaccination serologic testing* following a complete series of HepB vaccination

* Postvaccination serologic testing for persons other than infants born to HBsAg-positive (or HBsAg-unknown) mothers consists of anti-HBs.
Postvaccination serologic testing for infants born to HBsAg-positive (or HBsAg-unknown) mothers consists of anti-HBs and HBsAg. Persons with anti-HBs <10 mIU/mL after the primary vaccine series should be revaccinated. Infants born to HBsAg-positive mothers or mothers with an unknown HBsAg status should be revaccinated with a single dose of HepB vaccine and receive postvaccination serologic testing 1–2 months later. Infants whose anti-HBs remains <10 mIU/mL following single dose revaccination should receive two additional doses of HepB vaccine, followed by postvaccination serologic testing 1–2 months after the final dose. Based on clinical circumstances or family preference, HBsAg-negative infants with anti-HBs <10 mIU/mL may instead be revaccinated with a second, complete 3-dose series, followed by postvaccination serologic testing performed 1–2 months after the final dose of vaccine. For others with anti-HBs <10 mIU/mL after the primary series, administration of 3 additional HepB vaccine doses on an appropriate schedule, followed by anti-HBs testing 1–2 months after the final dose, is usually more practical than serologic testing after ≥1 dose of vaccine.

CME / ABIM MOC / CE

Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices

  • Authors: Sarah Schillie, MD; Claudia Vellozzi, MD; Arthur Reingold, MD; Aaron M. Harris, MD; Penina Haber, MPH; John W. Ward, MD; Noele P. Nelson, MD
  • CME / ABIM MOC / CE Released: 3/12/2018
  • THIS ACTIVITY HAS EXPIRED FOR CREDIT
  • Valid for credit through: 3/12/2019, 11:59 PM EST
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Target Audience and Goal Statement

This activity is intended for infectious disease specialists, family medicine specialists, gastroenterologists, internists, nephrologists, obstetrician-gynecologists, pediatricians, public health officials, nurses, pharmacists, and other clinicians caring for patients with or at risk for hepatitis B virus (HBV) infection.

Describe recommendations regarding prevention of HBV infection in the United States, based on updated guidance from the Advisory Committee on Immunization Practices.

Upon completion of this activity, participants will be able to:

  1. Discuss new or updated recommendations regarding prevention of hepatitis B virus (HBV) infection in the United States, based on updated guidance from the Advisory Committee on Immunization Practices (ACIP)
  2. Identify previously issued ACIP recommendations regarding prevention of HBV infection in the United States, including recommendations for HBV vaccination of infants, children, and adolescents
  3. Describe ACIP/Centers for Disease Control and Prevention recommendations for HBV prophylaxis after occupational and nonoccupational exposures


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Author(s)

  • Sarah Schillie, MD

    Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia

    Disclosures

    Disclosure: Sarah Schillie, MD, has disclosed no relevant financial relationships.

  • Claudia Vellozzi, MD

    Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia

    Disclosures

    Disclosure: Claudia Vellozzi, MD, has disclosed no relevant financial relationships.

  • Arthur Reingold, MD

    University of California, Berkeley School of Public Health, Berkeley, California

    Disclosures

    Disclosure: Arthur Reingold, MD, has disclosed no relevant financial relationships.

  • Aaron M. Harris, MD

    Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia

    Disclosures

    Disclosure: Aaron M. Harris, MD, has disclosed no relevant financial relationships.

  • Penina Haber, MPH

    Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia

    Disclosures

    Disclosure: Penina Haber, MPH, has disclosed no relevant financial relationships.

  • John W. Ward, MD

    Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia

    Disclosures

    Disclosure: John W. Ward, MD, has disclosed no relevant financial relationships.

  • Noele P. Nelson, MD

    Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia

    Disclosures

    Disclosure: Noele P. Nelson, MD, has disclosed no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer, Medscape, LLC

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed the following relevant financial relationships:
    Owns stock, stock options, or bonds from: Pfizer

CME Reviewer/Nurse Planner

  • Amy Bernard, MS, BSN, RN-BC

    Lead Nurse Planner, Medscape, LLC

    Disclosures

    Disclosure: Amy Bernard, MS, BSN, RN-BC, has disclosed no relevant financial relationships.


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CME / ABIM MOC / CE

Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices: Immunization Management Issues

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Immunization Management Issues

Prevaccination Testing

  • Vaccination of persons immune to HBV because of current or previous infection or HepB vaccination does not increase the risk for adverse events.[8] However, in populations that have high rates of previous HBV infection, prevaccination testing might reduce costs by avoiding vaccination of persons who are already immune. Prevaccination testing consists of testing for HBsAg, anti-HBs, and anti-HBc. Serologic testing should not be a barrier to vaccination of susceptible persons, especially in populations that are difficult to access. Testing is not a requirement for vaccination, and in settings where testing is not feasible, vaccination of recommended persons should continue.
  • The first dose of HepB vaccine should typically be administered immediately after collection of the blood for serologic testing. Prevaccination testing is recommended for the following persons ( Box 6 ):
    • household, sexual, or needle-sharing contacts of HBsAg-positive persons;
    • HIV-positive persons;
    • persons with elevated alanine aminotransferase (ALT)/aspartate aminotransferase (AST) of unknown etiology;
    • hemodialysis patients (refer to 2001 CDC recommendations [88] for additional information);
    • MSM; and
    • past or current injection-drug users.

Testing for HBV Infection

  • Testing for HBV infection (consisting of testing for HBsAg, anti-HBs, and anti-HBc) is also recommended for the following persons:
    • persons born in countries of high and intermediate HBV endemicity (HBsAg prevalence ≥2%);
    • U.S.-born persons not vaccinated as infants whose parents were born in countries with high HBV endemicity (≥8%);
    • persons needing immunosuppressive therapy, including chemotherapy, immunosuppression related to organ transplantation, and immunosuppression for rheumatologic or gastroenterologic disorders; and
    • donors of blood, plasma, organs, tissues, or semen.
      • All pregnant women should be tested for HBsAg during each pregnancy. Pregnant women with positive HBsAg tests should be tested for HBV DNA.

Postvaccination Serologic Testing

  • Serologic testing for immunity is not necessary after routine vaccination of infants, children, or adults.
  • Testing for anti-HBs after vaccination is recommended for the following persons whose subsequent clinical management depends on knowledge of their immune status ( Box 7 ):
    • infants born to HBsAg-positive women and infants born to women whose HBsAg status remains unknown (e.g., infants safely surrendered shortly after birth). Postvaccination serologic testing should consist of testing for anti-HBs and HBsAg;
    • HCP and public safety workers at risk for blood or body fluid exposure;
    • hemodialysis patients (and other persons who might require outpatient hemodialysis), HIV-infected persons, and other immunocompromised persons (e.g., hematopoietic stem-cell transplant recipients or persons receiving chemotherapy), to determine the need for revaccination and the type of follow-up testing; and
    • sex partners of HBsAg-positive persons, to determine the need for revaccination and for other methods of protection against HBV infection.
  • Testing should be performed 1–2 months after administration of the final dose of the vaccine series using a method that allows determination of a protective concentration of anti-HBs (≥10 mIU/mL).
    • Persons found to have anti-HBs concentrations of ≥10 mIU/mL after the primary vaccine series are considered to be immune.
    • Immunocompetent persons have long-term protection and do not need further periodic testing to assess anti-HBs levels.
    • Immunocompromised persons might need annual testing to assess anti-HBs concentrations (See Revaccination).
    • Persons found to have anti-HBs concentrations of <10 mIU/mL after the primary vaccine series should be revaccinated. Administration of all doses in the second series, on an appropriate schedule, followed by anti-HBs testing 1–2 months after the final dose, is usually more practical than serologic testing after one or more doses of vaccine (except for when revaccinating infants born to HBsAg-positive mothers).
    • Persons who do not have a protective concentration of anti-HBs after revaccination should be tested for HBsAg.
    • If the HBsAg test result is positive, the person should receive appropriate management, and any household, sexual, or needle-sharing contacts should be identified and vaccinated. Prevaccination testing (consisting of anti-HBc, HBsAg, and anti-HBs) to identify infected persons is recommended for household, sexual, or needle-sharing contacts of HBsAg-positive persons; serologic testing should not be a barrier to vaccination, and the first HepB vaccine dose should be administered immediately after collection of the blood for serologic testing.
    • Persons who test negative for HBsAg should be considered susceptible to HBV infection and should be counseled about precautions to prevent HBV infection and the need to obtain HBIG postexposure prophylaxis for any known or likely exposure to an HBsAg-positive source.[10]
  • Testing HCP with documentation of complete HepB vaccination for anti-HBs upon hire or matriculation (i.e., pre-exposure assessment of prior response to HepB vaccination), followed by one or more additional doses of HepB vaccine for HCP with anti-HBs <10 mIU/mL, helps to ensure that HCP will be protected if they have an exposure to HBV-containing blood or body fluids.
  • Anti-HBs levels of ≥10 mIU/mL are generally considered seroprotective; however, different assays have different assay cutoff values based on which reported levels of anti-HBs might vary depending on the assay used. Refer to the package insert of the test for the determination of actual/correct levels of anti-HBs antibodies.

Revaccination

  • Revaccination (i.e., booster dose, challenge dose, or revaccination with a complete series) is not generally recommended for persons with a normal immune status who were vaccinated as infants, children, adolescents, or adults. Available data do not suggest a maximum number of booster doses. Revaccination when anti-HBs is <10 mIU/mL is recommended for the following persons:
    • Infants born to HBsAg-positive mothers. HBsAg-negative infants with anti-HBs <10 mIU/mL should be revaccinated with a single dose of HepB vaccine, and retested 1–2 months later. Infants whose anti-HBs remains <10 mIU/mL following single dose revaccination should receive two additional doses of HepB vaccine on a vaccine schedule to complete the second series, followed by anti-HBs testing 1–2 months later. Alternatively, these infants may be revaccinated with a second 3-dose series and retested (HBsAg and anti-HBs) 1–2 months after the final dose of vaccine.
    • HCP. Completely vaccinated HCP with anti-HBs <10 mIU/mL should receive an additional dose of HepB vaccine, followed by anti-HBs testing 1–2 months later. HCP whose anti-HBs remains <10 mIU/mL should complete the second series (usually 6 doses total), followed by repeat anti-HBs testing 1–2 months after the final dose. Alternatively, it might be more practical for very recently vaccinated HCP with anti-HBs <10 mIU/mL to receive the second complete series (usually 6 doses total), followed by anti-HBs testing 1–2 months after the final dose.
    • Hemodialysis patients. For hemodialysis patients treated in outpatient centers, the need for booster doses should be assessed by annual anti-HBs testing. A booster dose should be administered when anti-HBs levels decline to <10 mIU/mL. Anti-HBs testing 1–2 months following the booster dose to assess response is not recommended.
    • Other immunocompromised persons. For other immunocompromised persons (e.g., HIV-infected persons, hematopoietic stem-cell transplant recipients, and persons receiving chemotherapy), the need for booster doses has not been determined. Annual anti-HBs testing and booster doses should be considered for persons with an ongoing risk for exposure.

Interrupted Schedules and Minimum Dosing Intervals

  • For all ages, when the HepB vaccine schedule is interrupted, the vaccine series does not need to be restarted. If the series is interrupted after the first dose, the second dose should be administered as soon as possible, and the second and third doses should be separated by an interval of at least 8 weeks. If only the third dose has been delayed, it should be administered as soon as possible. The final dose of vaccine must be administered at least 8 weeks after the second dose and should follow the first dose by at least 16 weeks; the minimum interval between the first and second doses is 4 weeks. Inadequate doses of Hep B vaccine or doses received after a shorter-than-recommended dosing interval should be readministered, using the correct dosage or schedule.
  • Vaccine doses administered =4 days before the minimum interval or age are considered valid. Because of the unique accelerated schedule for Twinrix, the 4-day guideline does not apply to the first 3 doses of this vaccine when administered on a 0-day, 7-day, 21–30-day, and 12-month schedule (new recommendation).
  • In infants, administration of the final dose is not recommended before age 24 weeks.

Other Immunization Management Issues

  • No differences in immunogenicity have been observed when one or 2 doses of HepB vaccine produced by one manufacturer are followed by doses from a different manufacturer.[8] Whenever feasible, the same vaccine should be used for the subsequent doses; however, if a different brand is administered, the dose should be considered valid and does not need to be repeated.
  • Providers should only accept dated records as evidence of HepB vaccination.
  • Although vaccinations should not be postponed if records cannot be found, an attempt to locate missing records should be made by contacting previous health care providers, reviewing state or local immunization information systems, and searching for a personally held record. If records cannot be located within a reasonable time, these persons should be considered susceptible and started on the age-appropriate vaccination schedule. An anti-HBs ≥10 mIU/mL is a serologic correlate of protection only when following a documented, complete series.
  • In all settings, vaccination should be initiated even though completion of the series might not be ensured.
  • Adverse events occurring after administration of any vaccine should be reported to VAERS. Reports should be submitted to VAERS online, by facsimile, or by mail. More information about VAERS is available by calling 1-800-822-7967 (toll-free) or online at https://vaers.hhs.gov.