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
Birthweight	Maternal HBsAg status	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
		3	6 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
		3	6 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
		3	6–18 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
		3	6–18 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
Children (1–10 yrs)	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
Adults (≥20 yrs)	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
HCP status	Source patient (HBsAg)	HCP testing (anti-HBs)	HBIG	Vaccination	Postvaccination serologic testing
Documented responder after complete series			No action needed
Documented nonresponder after two complete series	Positive/unknown	–*	HBIG x2 separated by 1 month	–	N/A
Documented nonresponder after two complete series	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
Unvaccinated/incompletely vaccinated or vaccine refusers	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
Exposure*	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

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.

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

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.

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

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

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.

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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

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

Start Activity

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:

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)
Identify previously issued ACIP recommendations regarding prevention of HBV infection in the United States, including recommendations for HBV vaccination of infants, children, and adolescents
Describe ACIP/Centers for Disease Control and Prevention recommendations for HBV prophylaxis after occupational and nonoccupational exposures

Disclosures

As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.

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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Recommendations

This section contains guidance for the prevention of HBV infection, including ACIP recommendations for HepB vaccination of infants, children, adolescents, and adults ( Box 4 ) and CDC and ACIP recommendations for HBV prophylaxis following occupational and nonoccupational exposures, respectively.

Prevention of Perinatal HBV Transmission

Identification and Management of HBV-Infected Pregnant Women

All pregnant women should be tested for HBsAg during an early prenatal visit (e.g., first trimester) in each pregnancy, even if they have been vaccinated or tested previously. Testing those pregnant women known to be chronically infected with HBV provides documentation of the positive HBsAg test result obtained during pregnancy and helps to ensure that their infants will be identified for timely prophylaxis.
- All HBsAg-positive pregnant women should be tested for HBV DNA to guide the use of maternal antiviral therapy during pregnancy for the prevention of perinatal HBV transmission (new recommendation).
- AASLD suggests maternal antiviral therapy when the maternal HBV DNA is >200,000 IU/mL (new recommendation).
- All HBsAg-positive pregnant women should be referred to their jurisdiction’s Perinatal Hepatitis B Prevention Program (PHBPP) for case management to ensure that their infants receive timely prophylaxis and follow-up. A copy of the original laboratory report indicating the pregnant woman’s HBsAg-positive status should be provided to the hospital or birthing facility where the delivery is planned and to the HCP who will care for the newborn infant.
- All HBsAg-positive pregnant women should receive information concerning HBV that discusses the potential use of antiviral therapy, the importance of prophylaxis for their infant (HepB vaccine and HBIG within 12 hours of birth), completion of the vaccine series, and postvaccination serologic testing.
Women not tested prenatally, those with clinical hepatitis, and those whose behaviors place them at high risk for HBV infection (e.g., recent or current injection-drug use, having had more than one sex partner in the previous 6 months or an HBsAg-positive sex partner, having been evaluated or treated for a STI) should be tested at the time of admission to the hospital or birthing facility for delivery.
All laboratories that provide HBsAg testing of pregnant women should use a Food and Drug Administration–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 postexposure prophylaxis of infants. Commercial laboratories should be encouraged to capture pregnancy status for women tested for HBsAg to aid in identification of HBV-infected pregnant women.

Management of Infants Born to Women Who Are HBsAg-Positive

All infants born to HBsAg-positive women should receive HepB vaccine and HBIG within 12 hours of birth, administered at different injection sites (e.g., separate limbs). Only single-antigen HepB vaccine should be used for the birth dose ( Table 3 ).
Infants born to women for whom HBsAg testing results during pregnancy are not available but other evidence suggestive of maternal HBV infection exists (e.g., presence of HBV DNA, HBeAg-positive, or mother known to be chronically infected with HBV) should be managed as if born to an HBsAg-positive mother (new recommendation).
The HepB vaccine series should be completed according to the recommended schedule for infants born to HBsAg-positive mothers. The final dose in the series should not be administered before age 24 weeks (164 days). Although not indicated in the manufacturers’ package labeling, Pediarix 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 HepB vaccine and HBIG.
For infants weighing <2,000 grams, the birth dose (i.e., the initial HepB vaccine dose) should not be counted as part of the vaccine series because of the potentially reduced immunogenicity of HepB 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. The final dose in the series should not be administered before age 24 weeks (164 days).
Postvaccination serologic testing for anti-HBs and HBsAg should be performed after completion of the vaccine series at age 9–12 months (generally at the next well-child visit following completion of the HepB vaccine series). Anti-HBs testing should be performed using a method that allows detection of the protective concentration of anti-HBs (≥10 mIU/mL). Testing should not be performed before age nine months to avoid detection of passive anti-HBs from HBIG administered at birth 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 HBsAg-positive mothers up 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 <10 mIU/mL should be revaccinated with a single dose of HepB vaccine and receive postvaccination serologic testing 1–2 months later (new recommendation). Infants whose anti-HBs remains <10 mIU/mL following single dose revaccination should receive two additional doses of HepB vaccine to complete the second series, 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.
- Available data do not suggest a benefit from administering additional HepB vaccine doses to infants who have not attained anti-HBs ≥10 mIU/mL following receipt of two complete HepB vaccine series.
- HBsAg-positive infants should be referred for appropriate follow-up.
Infants who are born to HBsAg-positive mothers and receive postexposure prophylaxis may be breastfed beginning immediately after birth.
For infants transferred to a different facility after birth (e.g., hospital with higher level of neonatal care), staff at the transferring and receiving facilities should communicate regarding the infant’s HepB vaccination and HBIG receipt status to ensure prophylaxis is administered in a timely manner (new recommendation).

Management of Infants Born to Women with Unknown HBsAg Status

Infants born to women for whom HBsAg testing results during pregnancy are not available but other evidence suggestive of maternal HBV infection exists (e.g., presence of HBV DNA, HBeAg-positive, or mother known to be chronically infected with HBV) should be managed as if born to an HBsAg-positive mother (new recommendation). The infant should receive both HepB vaccine and HBIG within 12 hours of birth.
Women admitted for delivery without documentation of HBsAg test results should have blood drawn and tested as soon as possible.
While maternal HBsAg test results are pending, infants with birth weights ≥2,000 grams born to women with an unknown HBsAg status should receive the first dose of HepB vaccine (without HBIG) within 12 hours of birth. Only single-antigen HepB vaccine should be used for the birth dose ( Table 3 ).
- If the mother is determined to be HBsAg-positive, the infant should receive HBIG as soon as possible but no later than age seven days, and the vaccine series should be completed according to the recommended schedule for infants born to HBsAg-positive mothers. The final dose in the series should not be administered before age 24 weeks (164 days). If the mother is determined to be HBsAg-negative, the vaccine series should be completed according to the recommended schedule for infants born to HBsAg-negative mothers. The final dose in the series should not be administered before age 24 weeks (164 days).
Because of the potentially decreased immunogenicity of vaccine in infants weighing <2,000 grams, these infants should receive both single-antigen HepB vaccine and HBIG, administered at different injection sites (e.g., separate limbs), if the mother’s HBsAg status cannot be determined within 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. The final dose in the series should not be administered before age 24 weeks (164 days).
- If it is not possible to determine the mother’s HBsAg status (e.g., when a parent or person with lawful custody safely surrenders an infant confidentially shortly after birth), the vaccine series should be completed according to a recommended schedule for infants born to HBsAg-positive mothers (new recommendation). The final dose in the series should not be administered before age 24 weeks (164 days). These infants should receive postvaccination serologic testing at age 9–12 months, and revaccination if necessary (new recommendation).
Anti-HBs testing should be performed using a method that allows detection of the protective concentration of anti-HBs (≥10 mIU/mL). Testing should not be performed before age nine months to avoid detection of passive anti-HBs from HBIG administered at birth 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 HBsAg-positive mothers up 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 <10 mIU/mL should be revaccinated with a single dose of HepB vaccine and receive postvaccination serologic testing 1–2 months later (new recommendation). Infants whose anti-HBs remains <10 mIU/mL following single dose revaccination should receive two additional doses of HepB vaccine to complete the second series, 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.
- Available data do not suggest a benefit from administering additional HepB vaccine doses to infants who have not attained anti-HBs ≥10 mIU/mL following receipt of two complete HepB vaccine series.
- HBsAg-positive infants should be referred for appropriate follow-up.
Infants born to mothers with unknown HBsAg status may be breastfed beginning immediately after birth.
For infants transferred to a different facility after birth (e.g., a hospital with a higher level of neonatal care), staff at the transferring and receiving facilities should communicate regarding the infant’s HepB vaccination and HBIG receipt status to ensure prophylaxis is administered in a timely manner (new recommendation).

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Page 7 of 12

CME / ABIM MOC / CE Information

References

Table 1.

Table 2.

Table 3.

Table 4.

Table 5.

Table 6.

Box 1.

Box 2.

Box 3.

Box 4.

Box 5.

Box 6.

Box 7.

CME / ABIM MOC / CE

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

Target Audience and Goal Statement

Disclosures

Author(s)

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 Author

Laurie Barclay, MD

CME Reviewer/Nurse Planner

Amy Bernard, MS, BSN, RN-BC

Accreditation Statements

For Physicians

For Nurses

For Pharmacists

Instructions for Participation and Credit

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

Recommendations

Prevention of Perinatal HBV Transmission

Table of Contents

Table 1.

Table 2.

Table 3.

Table 4.

Table 5.

Table 6.

Box 1.

Box 2.

Box 3.

Box 4.

Box 5.

Box 6.

Box 7.

References

Faculty and Disclosures

Author(s)

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 Author

Laurie Barclay, MD

CME Reviewer/Nurse Planner

Amy Bernard, MS, BSN, RN-BC

CME / ABIM MOC / CE

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

Target Audience and Goal Statement

Disclosures

Author(s)

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 Author

Laurie Barclay, MD

CME Reviewer/Nurse Planner

Amy Bernard, MS, BSN, RN-BC

Accreditation Statements

For Physicians

For Nurses

For Pharmacists

Instructions for Participation and Credit

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

Recommendations

Prevention of Perinatal HBV Transmission

Table of Contents