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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Postexposure Prophylaxis

This section provides recommendations for management of persons who are exposed to HBV through a distinct, identifiable exposure to blood or body fluids that contain blood, in occupational and nonoccupational settings.

Wounds and skin sites that have been in contact with blood or body fluids should be washed with soap and water; mucous membranes should be flushed with water. Using antiseptics (e.g., 2%–4% chlorhexidine) for wound care or expressing fluid by squeezing the wound further have not been shown to reduce the risk for HBV transmission; however, the use of antiseptics is not contraindicated. The application of caustic agents (e.g., bleach) or the injection of antiseptics or disinfectants into the wound is not recommended.

Occupational Settings

Vaccinated HCP

For vaccinated HCP (who have written documentation of a complete HepB vaccine series) with subsequent documented anti-HBs ≥10 mIU/mL, testing the source patient for HBsAg is unnecessary. No postexposure prophylaxis for HBV is necessary, regardless of the source patient’s HBsAg status ( Table 5 ).TABLE 5Postexposure 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
For vaccinated HCP (who have written documentation of a complete HepB vaccine series) without previous anti-HBs testing, the HCP should be tested for anti-HBs and the source patient (if known) should be tested for HBsAg as soon as possible after the exposure. Anti-HBs testing should be performed using a method that allows detection of the protective concentration of anti-HBs (≥10 mIU/mL). Testing the source patient and the HCP should occur simultaneously; testing the source patient should not be delayed while waiting for the HCP anti-HBs test results, and likewise, testing the HCP should not be delayed while waiting for the source patient’s HBsAg results ( Table 5 ).
- If the HCP has anti-HBs <10 mIU/mL and the source patient is HBsAg-positive or has an unknown HBsAg status, the HCP should receive 1 dose of HBIG and be revaccinated as soon as possible after the exposure. HepB vaccine may be administered simultaneously with HBIG at a separate anatomical injection site (e.g., separate limb). The HCP should then receive the second 2 doses of HepB vaccine to complete the second series (likely 6 doses total when accounting for the original series) according to the vaccination schedule. So the HCP’s vaccine response status can be documented for future exposures, anti-HBs testing should be performed 1–2 months after the final vaccine dose.
- If the HCP has anti-HBs <10 mIU/mL and the source patient is HBsAg-negative, the HCP should receive an additional single HepB vaccine dose, followed by repeat anti-HBs testing 1–2 months later. HCP whose anti-HBs remains <10 mIU/mL should undergo revaccination with two more doses (likely 6 doses total when accounting for the original series). So the HCP’s vaccine response status can be documented for future exposures, anti-HBs testing should be performed 1–2 months after the final dose of vaccine.
- If the HCP has anti-HBs ≥10 mIU/mL at the time of the exposure, no postexposure HBV management is necessary, regardless of the source patient’s HBsAg status.
For vaccinated HCP with anti-HBs <10 mIU/mL after two complete HepB vaccine series, the source patient should be tested for HBsAg as soon as possible after the exposure. If the source patient is HBsAg-positive or has unknown HBsAg status, the HCP should receive 2 doses of HBIG.^[1,10] The first dose should be administered as soon as possible after the exposure, and the second dose should be administered 1 month later. HepB vaccine is not recommended for the exposed HCP who has previously completed two HepB vaccine series. If the source patient is HBsAg-negative, neither HBIG nor HepB vaccine is necessary ( Table 5 ).

Unvaccinated HCP

For unvaccinated or incompletely vaccinated HCP, the source patient should be tested for HBsAg as soon as possible after the exposure. Testing unvaccinated or incompletely vaccinated HCP for anti-HBs is not necessary and is potentially misleading, because anti-HBs ≥10 mIU/mL as a correlate of vaccine-induced protection has only been determined for persons who have completed an approved vaccination series^[107] ( Table 5 ).
If the source patient is HBsAg-positive or has an unknown HBsAg status, the HCP should receive 1 dose of HBIG and 1 dose of HepB vaccine administered as soon as possible after the exposure. HepB vaccine may be administered simultaneously with HBIG at a separate anatomical injection site (e.g., separate limb). The HCP should complete the HepB vaccine series according to the vaccination schedule. To document the HCP’s vaccine response status for future exposures, anti-HBs testing should be performed approximately 1–2 months after the final vaccine dose. Anti-HBs testing should be performed using a method that allows detection of the protective concentration of anti-HBs (≥10 mIU/mL). Because anti-HBs testing of HCP who received HBIG should be performed after anti-HBs from HBIG is no longer detectable (6 months after administration), it might be necessary to defer anti-HBs testing for a period longer than 1–2 months after the last vaccine dose in these situations ( Table 5 ).
HCP with anti-HBs ≥10 mIU/mL after receipt of the primary vaccine series are considered immune. Immunocompetent persons have long-term protection and do not need further periodic testing to assess anti-HBs levels.
HCP with anti-HBs <10 mIU/mL after receipt of the primary series should be revaccinated. For these HCP, administration of a second complete series on an appropriate schedule, followed by anti-HBs testing 1–2 months after the final dose, is usually more practical than conducting serologic testing after each additional dose of vaccine. So the HCP’s vaccine response status can be documented for future exposures, anti-HBs testing should be performed 1–2 months after the final vaccine dose.
If the source patient is HBsAg-negative, the HCP should complete the HepB vaccine series according to the vaccination schedule. So the HCP’s vaccine response status can be documented for future exposures, anti-HBs testing should be performed approximately 1–2 months after the final vaccine dose ( Table 5 ).
HCP with anti-HBs ≥10 mIU/mL after receipt of the primary vaccine series are considered immune. Immunocompetent persons have long-term protection and do not need further periodic testing to assess anti-HBs levels.
HCP with anti-HBs <10 mIU/mL after receipt of the primary series should be revaccinated. For these HCP, administration of a second complete series on an appropriate schedule, followed by anti-HBs testing 1–2 months after the final dose, is usually more practical than conducting serologic testing after each additional dose of vaccine. So the HCP’s vaccine response status can be documented for future exposures, anti-HBs testing should be performed 1–2 months after the final vaccine dose.

Clinical Management of Exposed HCP

HCP who have anti-HBs <10 mIU/mL (or who are unvaccinated or incompletely vaccinated) and sustain an exposure to a source patient who is HBsAg-positive or has an unknown HBsAg status should undergo baseline testing for HBV infection as soon as possible after the exposure, and follow-up testing approximately 6 months later. Testing immediately after the exposure should consist of total anti-HBc, and follow-up testing approximately 6 months later should consist of HBsAg and total anti-HBc ( Table 5 ).
HCP exposed to a source patient who is HBsAg-positive or has an unknown HBsAg status do not need to take special precautions to prevent secondary transmission during the follow-up period; however, they should refrain from donating blood, plasma, organs, tissue, or semen.^[10] The exposed HCP does not need to modify sexual practices or refrain from becoming pregnant.^[10] If an exposed HCP is breastfeeding, she does not need to discontinue.^[7,10] No modifications to an exposed HCP’s patient-care responsibilities are necessary to prevent transmission to patients based solely on exposure to a source patient who is HBsAg-positive or has an unknown HBsAg status.

Previously Vaccinated HCP

Providers should only accept written, dated records as evidence of HepB vaccination.^[151]
An increasing number of HCP have received routine HepB vaccination during childhood. No postvaccination serologic testing is recommended after routine infant or adolescent HepB vaccination. Because vaccine-induced anti-HBs wanes over time, testing HCP for anti-HBs years after vaccination might not distinguish vaccine nonresponders from responders. Pre-exposure assessment of current or past anti-HBs results upon hire or matriculation, followed by one or more additional doses of HepB vaccine for HCP with anti-HBs <10 mIU/mL and retesting anti-HBs, if necessary, helps to ensure that HCP will be protected if they have an exposure to HBV-containing blood or body fluids (Box 5 ; Figure 3).
HCP who cannot provide documentation of 3 doses of HepB vaccine should be considered unvaccinated and should complete the vaccine series. Postvaccination serologic testing for anti-HBs is recommended 1–2 months after the third vaccine dose. HCP who are inadvertently tested before receiving 3 documented doses of HepB vaccine and have anti-HBs ≥10 mIU/mL should not be considered immune because anti-HBs ≥10 mIU/mL is a known correlate of protection only when testing follows a documented 3-dose series. Health care facilities are encouraged to try to locate vaccine records for HCP and to enter all vaccine doses in their state immunization information system.

Nonoccupational Settings

HBsAg-Positive Source

This section provides recommendations for management of persons who are exposed to HBV through a distinct, identifiable exposure to blood or body fluids that contain blood, in nonoccupational settings ( Table 6 ). The exposed person does not need to undergo postvaccination serologic testing following vaccination based solely on being exposed.

Exposed persons who have written documentation of a complete HepB vaccine series and who did not receive postvaccination testing should receive a single dose of HepB vaccine.
Exposed persons who are in the process of being vaccinated but who have not completed the vaccine series should receive a dose of HBIG and complete the HepB vaccine series (it is not necessary to restart the HepB vaccine series). HepB vaccine may be administered simultaneously with HBIG at a separate anatomical injection site (e.g., separate limb).
Exposed unvaccinated persons should receive both HBIG and HepB vaccine as soon as possible after exposure (preferably within 24 hours). HepB vaccine may be administered simultaneously with HBIG at a separate anatomical injection site (e.g., separate limbs). Studies are limited on the maximum interval after exposure during which postexposure prophylaxis is effective, but the interval is unlikely to exceed 7 days for percutaneous exposure and 14 days for sexual exposures. The HepB vaccine series should be completed according to the vaccination schedule.

HBsAg-Unknown Source

Exposed persons with written documentation of a complete HepB vaccine series require no further treatment.
Exposed persons who are in the process of being vaccinated but who are not fully vaccinated should complete the HepB vaccine series (it is not necessary to restart the vaccination series).
Exposed unvaccinated persons should receive the HepB vaccine series with the first dose administered as soon as possible after exposure, preferably within 24 hours. Studies are limited on the maximum interval after exposure during which postexposure prophylaxis is effective, but the interval is unlikely to exceed 7 days for percutaneous exposure and 14 days for sexual exposures. The vaccine series should be completed according to the vaccination schedule.

Previously Vaccinated HCP

Providers should only accept written, dated records as evidence of HepB vaccination.^[151]
An increasing number of HCP have received routine HepB vaccination during childhood. No postvaccination serologic testing is recommended after routine infant or adolescent HepB vaccination. Because vaccine-induced anti-HBs wanes over time, testing HCP for anti-HBs years after vaccination might not distinguish vaccine nonresponders from responders. Pre-exposure assessment of current or past anti-HBs results upon hire or matriculation, followed by one or more additional doses of HepB vaccine for HCP with anti-HBs <10 mIU/mL and retesting anti-HBs, if necessary, helps to ensure that HCP will be protected if they have an exposure to HBV-containing blood or body fluids ( Box 5 ; Figure 3).
- HCP who cannot provide documentation of 3 doses of HepB vaccine should be considered unvaccinated and should complete the vaccine series. Postvaccination serologic testing for anti-HBs is recommended 1–2 months after the third vaccine dose. HCP who are inadvertently tested before receiving 3 documented doses of HepB vaccine and have anti-HBs ≥10 mIU/mL should not be considered immune because anti-HBs ≥10 mIU/mL is a known correlate of protection only when testing follows a documented 3-dose series. Health care facilities are encouraged to try to locate vaccine records for HCP and to enter all vaccine doses in their state immunization information system.

Enlarge

Figure 3. Pre-exposure evaluation for health care personnel previously vaccinated with complete, ≥3-dose HepB vaccine series who have not had postvaccination serologic testing*
Source: Adapted from CDC. 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 2006;55(No. RR-16).
* Should be performed 1–2 months after the last dose of vaccine using a quantitative method that allows detection of the protective concentration of anti-HBs (≥10 mIU/mL) (e.g., enzyme-linked immunosorbent assay [ELISA]).

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Page 10 of 12

Immunization Management Issues

CME / ABIM MOC / CE Information

Summary
Introduction
New or Updated Recommendations
Methods
HBV Background
Prophylaxis Against HBV Infection
Recommendations
Persons Recommended for HepB Vaccination
Implementation Strategies
Postexposure Prophylaxis
Immunization Management Issues
Future Directions

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: Postexposure Prophylaxis

Postexposure Prophylaxis

Occupational Settings

Nonoccupational Settings

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: Postexposure Prophylaxis

Postexposure Prophylaxis

Occupational Settings

Nonoccupational Settings

Table of Contents