| Hepatitis B |
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| Disease Issues |
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| What are the
signs and symptoms of hepatitis B? |
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| About 30%–50%
people who are 5 years of age or older with
acute (recently acquired) hepatitis B have
initial signs or symptoms when infected with
hepatitis B virus
(HBV). Children younger than age 5 years and
newly infected immunosuppressed adults rarely
show any symptoms. When present, signs and
symptoms of hepatitis B
might include nausea, lack of appetite,
tiredness, muscle, joint, or abdominal pain,
fever, diarrhea or vomiting, headache, dark
urine, clay-colored stools, and yellowing of
the skin and whites of the eyes (jaundice).
People who have such signs or symptoms
generally feel quite ill and might need to be
hospitalized. In 2015, an estimated
21,900 new HBV infections occurred. A total of
1,714 hepatitis B-related deaths were
reported, with the highest fatality rates in
adults age 55 through 64 years of age.
People with chronic (life-long) HBV infection
might have no symptoms, have no evidence of
liver disease, or have a range of disease from
chronic hepatitis to cirrhosis or
hepatocellular carcinoma, a type of liver
cancer. |
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| How long does
it take to show signs of illness after a
person becomes infected with HBV? |
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| If signs or
symptoms of illness occur, they begin an
average of 90 days (range: 60–150 days) after
exposure to HBV. |
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| How is
hepatitis B virus (HBV) transmitted? |
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| Persons with
chronic HBV infection (those with persistent
hepatitis B surface antigen [HBsAg] in the
serum for at least 6 months) serve as the main
reservoir for HBV
transmission. |
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| HBV is
transmitted through percutaneous (through the
skin), mucosal, or non-intact skin exposure to
infectious blood or body fluids. HBV is
concentrated most highly in
blood, and percutaneous exposure is an
efficient mode of transmission. Semen and
vaginal secretions are infectious, and HBV
also can be detected in saliva, tears, and
bile. Cerebrospinal fluid, synovial fluid,
pleural fluid, peritoneal fluid, pericardial
fluid, and amniotic fluid are also considered
potentially infectious. Urine, feces, vomitus,
nasopharyngeal washings, sputum, and sweat are
not efficient vehicles of transmission unless
they contain blood because they contain low
quantities of infectious HBV.
Hepatitis B surface antigen (HBsAg) found in
breast milk is also unlikely to lead to
transmission so HBV infection is not a
contraindication to breastfeeding. |
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| Among adults in
the U.S., HBV is transmitted primarily by
percutaneous exposure to blood (for example,
injection drug use) and sexual contact. HBV is
transmitted
efficiently by sexual contact both among
heterosexuals and among men who have sex with
men (MSM). Risk factors for sexual
transmission among heterosexuals include
having unprotected sex with an infected
partner, having unprotected sex with more than
one partner, and a history of another sexually
transmitted infection (STI). |
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| Risk factors
associated with sexual transmission among MSM
include having multiple sex partners, history
of another STI, and anal intercourse.
Transmission can occur
from interpersonal contact (e.g., sharing a
toothbrush or razor, contact with exudates
from dermatologic lesions, or contact with HBsAg-contaminated surfaces) and in
settings such as schools, child care centers,
and facilities for developmentally disabled
persons. |
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| Transmission of
HBV from transfusion of blood or blood
products is rare because of donor screening
and viral inactivation procedures. Other
possible sources of
infection include contaminated medical or
dental instruments, unsafe injections,
needle-stick injuries, organ transplantation,
and dialysis. |
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| More of my
patients are getting tattoos and body
piercings. Should they be concerned about
contracting a bloodborne infection like HBV? |
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| Yes. Even though
tattooing and body piercing are not thought to
be a significant mode of transmission for HBV, tattooing and body piercing have the potential
to transmit
bloodborne infections, including HBV,
hepatitis C virus (HCV), and human
immunodeficiency virus (HIV), if the person
doing the tattoos or body piercing does not
use
good infection control practices. The Centers
for Disease Control and Prevention (CDC)
recommends that instruments or materials
(including ink), intended to penetrate
the skin be used once, then disposed of or thoroughly cleaned and sterilized between
clients. Personal service workers who do
tattooing or body piercing should be
educated about the transmission of bloodborne
pathogens and what precautions are needed to
prevent transmission. |
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| People
considering getting a tattoo or having a body
part pierced should ask staff at the
establishment what procedures they use to
prevent the spread of bloodborne
infections. They also might call the local
health department to find out what
sterilization procedures are required by law
or ordinance for tattooing and body piercing
establishments. |
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| What is the
risk for transmitting HBV by oral sex? |
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| There are no
specific data on transmission of bloodborne
viruses through oral-genital sex. Saliva has
not been associated with HBV transmission
unless biting has taken
place. HBV is not spread by kissing, hugging,
sneezing, coughing, food or water, sharing
eating utensils or drinking glasses, or casual
contact. |
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| If a patient
is diagnosed with acute hepatitis B and then
resolves the infection, can the patient ever
get hepatitis B again? |
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| Generally
speaking, no. It is possible, however, for a
person to have two different HBV infections,
the second due to an HBV variant or a
different HBV subtype. This is
not a common occurrence. |
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| How stable is
HBV in the environment? What types of
equipment cleaners are effective against HBV? |
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| HBV is stable in
the environment and remains viable for 7 or
more days on environmental surfaces at room temperature. HBV can be transmitted despite
the absence of
visible blood. Any high level disinfectant
that is tuberculocidal will inactivate HBV. |
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| What are
the various serologic tests for hepatitis B? |
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| Table
1: Hepatitis B laboratory nomenclature |
| HBsAg: |
Hepatitis
B surface antigen is a marker of infectivity.
Its presence indicates either acute or chronic
HBV infection. |
| anti-HBs: |
Antibody
to hepatitis B surface antigen is a marker
of immunity. Its presence indicates an immune response
to HBV infection, an immune response to vaccination,
or the presence of passively acquired antibody.
(It is also known as HBsAb, but this
abbreviation is best avoided since it is often
confused with abbreviations such as HBsAg.) |
| anti-HBc
(total): |
Antibody
to hepatitis B core antigen is a nonspecific
marker of acute, chronic, or resolved HBV infection.
It is not a marker of vaccine-induced immunity.
It may be used in prevaccination testing to determine
previous exposure to HBV infection. (It is also
known as HBcAb, but this abbreviation
is best avoided since it is often confused with
other abbreviations.) |
| IgM
anti-HBc: |
IgM antibody
subclass of anti-HBc. Positivity indicates
recent infection with HBV (<6 mos). Its
presence indicates acute infection. |
| HBeAg: |
Hepatitis
B "e" antigen is a marker of a high
degree of HBV infectivity, and it correlates with
a high level of HBV replication. It is primarily
used to help determine the clinical management
of patients with chronic HBV infection. |
| Anti-HBe: |
Antibody
to hepatitis B "e" antigen may be
present in an infected or immune person. In persons
with chronic HBV infection, its presence suggests
a low viral titer and a low degree of infectivity. |
|
HBV-DNA: |
HBV Deoxyribonucleic acid is a
measure of viral load and reflects viral
replication. It correlates well with
infectivity. It is used to assess and
monitor the
treatment of patients with chronic HBV
infection. |
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| How do I
interpret some of the common hepatitis B panel results? |
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Table 2 |
| Tests |
Results |
Interpretation |
Vaccinate? |
HBsAg
anti-HBc
anti-HBs |
negative
negative
negative |
susceptible |
vaccinate
if indicated |
HBsAg
anti-HBc
anti-HBs |
negative
negative
positive with >10mIU/mL* |
immune
due to vaccination (or may represent passive transfer of antibodies from receipt of HBIG) |
no
vaccination necessary |
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs |
negative
positive
negative
positive |
immune
due to natural infection |
no
vaccination necessary |
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs |
negative
positive
positive
positive |
acute resolving infection |
no
vaccination necessary |
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs |
positive
positive
positive
negative |
acutely
infected |
no
vaccination necessary |
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs |
positive
positive
negative
negative |
chronically
infected |
no
vaccination necessary (may need treatment) |
HBsAg
anti-HBc
anti-HBs |
negative
positive
negative |
four
interpretations possible† |
use
clinical judgment |
| * |
Postvaccination testing, when it is recommended,
should be performed 1-2 months after the last dose of
vaccine. Infants born to HBsAg-positive mothers should
be tested for HBsAg and anti-HBs after completion of
at least 3 doses of a licensed hepatitis B vaccination
series, at age 9-18 months (generally at the next well
child visit). |
| †1. |
May be distantly immune, but the test
may not be sensitive enough to detect
a very low level of anti-HBs in serum |
| 2. |
May be susceptible with a false
positive anti-HBc |
| 3. |
May be chronically infected and have
an undetectable level of HBsAg present
in the serum |
| 4. |
Passive transfer of antibody following HBIG administration or from an HBsAg-positive mother to her newborn |
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| Who should be
tested for anti-HBs after vaccination? |
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| Serologic testing
for immunity is not necessary or recommended
after routine vaccination of infants,
children, or adults. Testing for anti-HBs
after vaccination is
recommended for the following groups whose
subsequent clinical management depends on
knowledge of their immune status: |
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- Infants born to HBsAg-positive women and infants born to women
whose HBsAg status remains unknown (for example, infants surrendered shortly after
birth);
postvaccination serologic testing should
consist of testing for anti-HBs and HBsAg
- Healthcare professionals and public safety
workers at risk for blood or body fluid
exposure
- Hemodialysis patients (and other persons who
might require outpatient hemodialysis),
HIV-infected persons, and other
immunocompromised persons (such as
hematopoietic stem-cell transplant recipients
or persons receiving chemotherapy), to
determine the need for revaccination and the
type of follow-up testing, and
- Sex partners of HBsAg-positive persons, to
determine if they have not achieved immunity
and will need revaccination and to continue to
use other methods of
protection against HBV infection.
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| Testing should be
performed 1–2 months after administration of
the final dose of the vaccine series using a
method that allows determination of a
protective concentration
of anti-HBs (10 mIU/mL or higher). |
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| I have a
patient who is positive for anti-HBc
(hepatitis B core antibody) but negative for
all other hepatitis B serologic markers.
Should he receive hepatitis B vaccine? |
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| Some isolated
positive anti-HBc results are false positives
(it is the most common false positive HBV
marker). If that can be established, the
individual can and likely
should be vaccinated, assuming there is an
indication or desire to be protected. If the
positive anti-HBc is believed to be a true
positive, the individual would not require
vaccination since they have already
(presumably) had HBV infection. Isolated
positive anti-HBc could indicate low-level
chronic infection. In an infant isolated anti-HBc
could indicate passive transfer of antibody
from a mother who is HBsAg positive. People
found to be anti-HBc positive should be tested
for HBsAg. HBsAg testing may be
performed on the same specimen collected for
anti-HBc testing. If the HBsAg test result is
positive, the person is infected and should receive appropriate management. |
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| I work in a
dialysis unit. Our lab reports anti-HBs
results as adequate or inadequate, rather than
providing a quantitative result. Is this
acceptable? |
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| Reporting of
adequate and inadequate is acceptable only if
your lab is using mIUs as the measurement for
anti-HBs and the cutoff is below 10 mIU for
reporting
inadequate anti-HBs and 10 mIU or higher for
reporting adequate anti-HBs. You should check
with your lab to be certain this is being
done. |
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| We did a
hepatitis B panel for a new hospital employee
from Gambia. She had no documentation of
having been vaccinated. Her results showed HBsAg nonreactive,
anti-HBc reactive, IgM anti-HBc nonreactive,
and anti-HBs borderline. We don’t know how to
interpret these results. Should she be
immunized? |
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| Most likely this
person has a resolved hepatitis B infection
and is immune. However, it would be preferable
to test her again for all these serologic
markers, and also
quantify the anti-HBs result. If the results
are still positive for anti-HBc, and anti-HBs
is less than the immune level of 10 mIU/mL,
you can give her one dose of hepatitis B
vaccine and test again in 1–2 months. If the
anti-HBs is positive (10 mIU/mL or higher),
she is immune. No further action is needed
other than to document the results. If
the anti-HBs is still negative, complete the
vaccine series and test again 1–2 months after
the last dose of vaccine. |
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| Where can I
locate CDC's recommendations for hepatitis B
vaccination? |
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| The most recent
comprehensive recommendations for hepatitis B
vaccination were published in January 2018.
The document is available at
www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF.
Recommendations for the use of adjuvanted
hepatitis B vaccine (Heplisav-B, Dynavax) were
published in April 2018
and are available at
www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm6715a5-H.pdf. |
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| Please
describe the currently available hepatitis B
vaccines. |
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| All hepatitis B
(HepB) vaccines currently available in the
United States contain recombinant hepatitis B
surface antigen (HBsAg) produced in yeast
cells. Hepatitis B
vaccines are available as a single-antigen
formulation and in combination with other
vaccines. Of the three single antigen vaccines
available in the United States,
Engerix-B (GlaxoSmithKline) and Recombivax HB
(Merck) are approved for vaccination starting
at birth. Heplisav-B (Dynavax) is approved
only for persons 18 years of
age and older. |
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| Engerix-B and
Recombivax HB are available in both pediatric
and adult formulations. For the 3-dose series
of both vaccines, persons 0 through 19 years
of age receive a
0.5 mL dose regardless of their height or
weight. Persons 20 years of age and older
receive a 1.0 mL dose. |
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| Two combination
vaccines that contain hepatitis B are
available. Pediarix
(GlaxoSmithKline) is approved for children 6
weeks through 6 years of age and contains
HepB, DTaP, and inactivated poliovirus. Twinrix (GlaxoSmithKline) is approved for
persons 18 years of age and older and contains
HepB and inactivated hepatitis A virus. Comvax
(Merck), a combination vaccine that contained
HepB and Haemophilus
influenzae type b is no longer available in
the United States. |
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| The adult
formulation of Engerix-B contains twice as
much antigen per dose as the adult
formulations of Recombivax HB. If a patient
received 10 mcg (1 mL) of
Recombivax for the first dose, and I stock
only Engerix, should I give a 10 mcg (0.5 mL)
dose of Engerix for subsequent doses? |
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| No. It is the
volume of the dose, not the antigen content,
that is important. Persons 20 years and older
should always receive a 1.0 mL dose of either
Engerix-B or
Recombivax HB. Likewise, persons younger than
20 years should always receive a 0.5 mL dose
of the pediatric formulation of either Engerix-B
or Recombivax HB. |
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| Please provide
information about Heplisav-B. |
|
| Heplisav-B was
approved by the Food and Drug Administration
in November 2017 for persons 18 years of age
and older. Heplisav-B contains a novel
immunostimulatory
adjuvant (CpG 1018) that binds to Toll-like
receptor 9 to stimulate a directed immune
response to HBsAg. It is provided in a single
dose 0.5 mL vial and given as a 2-dose
series with doses separated by 1 month. |
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| Heplisav-B was
approved based on clinical trials that
compared seroprotection rates (SPR, defined as
anti-HBs of 10 mIU or higher) following 2
doses of Heplisav-B to
rates following 3 doses of Engerix-B
(GlaxoSmithKline). Among persons 18 through 70
years of age, SPRs were 90%–95% following 2
doses of Heplisav-B and 65%–
81% following 3 doses of Engerix-B. Local
reactions were most commonly reported
(injection site pain, redness, and swelling)
and were similar in frequency to those
following Engerix-B. |
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| What is the
schedule for hepatitis B vaccine? |
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| Primary
vaccination with Engerix-B, Recombivax HB, or
Twinrix consists of three intramuscular doses
administered on a 0-, 1-, and 6-month
schedule. Heplisav-B is
administered intramuscularly on a 2-dose
schedule with doses separated by 1 month. |
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| Alternative
vaccination schedules for Engerix-B and
Recombivax HB (for example, 0, 1, and 4 months
or 0, 2, and 4 months) have been demonstrated
to elicit dose-specific and final rates of seroprotection
similar to those obtained on a 0-, 1-, and
6-month schedule. Increasing the interval
between the first 2 doses has little effect on
immunogenicity or the final antibody
concentration. The third dose confers the
maximum level of seroprotection and provides
long-term protection. |
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| Recombivax HB may
be administered in a 2-dose schedule at 0 and
4–6 months for adolescents 11 through 15 years of age using the adult formulation (1.0 mL).
Pediarix
is administered at ages 2, 4, and 6 months; it
is not used for the birth dose. Twinrix may be
administered on an accelerated schedule at 0,
7, and 21–30 days, followed by
a dose at 12 months. |
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| Hepatitis B
vaccination of adult (20 years old and older)
hemodialysis patients consists of high-dose
(40 µg) Recombivax HB administered on a 0-,
1-, and 6-month
schedule or high-dose (2 mL) Engerix-B
administered on a 0-, 1-, 2-, and 6-month
schedule. The Heplisav-B schedule for
hemodialysis patients is two 0.5 mL doses,
separated by 1 month. |
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| If the
vaccination series is interrupted does the
series need to be restarted? |
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| For all ages,
when the hepatitis B vaccine schedule is
interrupted, the vaccine series does not need
to be restarted. For Engerix-B and Recombivax
HB, 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 at least 8 weeks. If
only the third dose has been delayed, it
should be administered as soon as possible. If
the Heplisav-B series is interrupted, the
second (final) dose should be given as
soon as possible. |
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| What are the
minimum intervals between doses in the
hepatitis B vaccine series? |
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| For Engerix-B and
Recombivax HB, the minimum interval between
the first and second doses is 4 weeks. 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. Vaccine doses
administered 4 or fewer days before the
minimum interval or age are
considered valid. Doses received 5 or more
days before the minimum interval or age should
be repeated using the correct schedule.
Because of the unique accelerated
schedule for Twinrix, the 4-day “grace period”
does not apply to the first three doses of
this vaccine when administered on a 0-, 7-,
21–30-day, and 12-month schedule.
The minimum interval between doses of Heplisav-B
is 4 weeks. |
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| We
inadvertently gave a 25-year-old a pediatric
(0.5 mL) dose of Engerix-B. Can we just give
her another pediatric dose or should she
receive a repeat adult dose? |
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| What you do
depends on when the error is identified. If
the error is discovered while the person is
still in the office, you can administer the
other "half" of the Engerix-B
dose. If the error is discovered later, the
dose should not be counted. The person should
be recalled to the office and given a full
age-appropriate 1.0 mL repeat dose. The
same recommendation would apply if the error
was with Recombivax HB. |
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| Can Heplisav-B
be used to complete a vaccination series
started with Engerix-B or Recombivax HB? |
|
| Yes. However,
data are limited on the safety and
immunogenicity effects when Heplisav-B is
interchanged with hepatitis B vaccines from
other manufacturers. When
feasible, the same manufacturer’s vaccines
should be used to complete the series.
However, vaccination should not be deferred
when the manufacturer of the previously
administered vaccine is unknown or when the
vaccine from the same manufacturer is
unavailable. |
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| The 2-dose
hepatitis B vaccine series for adults only
applies when both doses in the series consist
of Heplisav-B. Series consisting of a
combination of 1 dose of Heplisav-B and a vaccine from a different
manufacturer should consist of 3 total vaccine
doses and should adhere to the 3-dose schedule
minimum intervals of 4 weeks
between dose 1 and 2, 8 weeks between dose 2
and 3, and 16 weeks between dose 1 and 3.
Doses administered at less than the minimum
interval should be repeated.
However, a series containing 2 doses of
Heplisav-B administered at least 4 weeks apart
is valid, even if the patient received a
single earlier dose from another
manufacturer. |
|
| How long is
hepatitis B vaccine protective? |
|
| Studies indicate
that immunologic memory remains intact for at
least 30 years and confers protection against
clinical illness and chronic HBV infection,
even though
anti-HBs levels that once measured adequate
might become low or decline below detectable
levels. If exposed to HBV, people whose immune
systems are competent will
mount an anamnestic response and develop
protective anti-HBs. Studies are on-going to
assess whether booster doses of hepatitis B
vaccine will be needed in the future. |
|
| I tested
positive for chronic HBV infection about 5
months ago. I know there is a vaccine to
prevent transmission, however, I would like to
know how long my sex partner
should wait after taking this vaccine, before
having sex with me without any risk of
transmission? |
|
| You should use
condoms until a postvaccination blood test
(hepatitis B surface antibody, or anti-HBs)
shows that your sex partner is protected from
HBV infection. The
efficacy of latex condoms in preventing
infection with HBV is unknown, but their
proper use might reduce the risk of
transmission. Your sexual partner should have
the 2-
or 3-dose series of hepatitis B vaccine
(depending on brand) and postvaccination blood
testing 1 to 2 months after the last dose of
vaccine. If your sex partner's test
shows adequate anti-HBs (at least 10 mIU/mL),
then he/she should be protected against HBV
infection. |
|
| Where can I
find out about vaccine shortages? |
|
| For detailed
information about hepatitis B vaccine and
other vaccine shortages, go to CDC's website
at
www.cdc.gov/vaccines/vac-gen/shortages. |
|
| My adult
patient is traveling to Nigeria in three days.
She is already immune to hepatitis A, but we
want to provide protection for hepatitis B.
She received Twinrix two
weeks ago and then a dose of single-component hepatitis B vaccine one week ago. How can we
best provide protection in this circumstance? |
|
| Even though ACIP
does not recommend an accelerated hepatitis B
vaccine schedule in routine circumstances, a
4-dose series at 0, 7, 14 days, and 6 months
is
acceptable (see
https://www.cdc.gov/mmwr/PDF/rr/rr5516.pdf,
page 27). Although this schedule deviates from
the routine recommendation it can be used if
travel is
imminent. Give a dose of hepatitis B vaccine
now which will complete 3 of the 4-dose
accelerated schedule. She will need a fourth
and final dose 6 months after the first
dose in the accelerated schedule. |
|
| An adolescent
received the first dose of hepatitis B vaccine
at age 11 years but did not return for
subsequent doses. If the patient comes back at
age 16 years, is it
necessary to repeat the first dose of the
series? |
|
| It is not
necessary to restart or add doses to the
hepatitis B series (or any other routine
vaccine series) because of a prolonged
interval between doses. Just continue the
series from the point where it was
interrupted. Note that the 2-dose Recombivax
HB series using the adult formulation is
approved only for adolescents 11 through 15
years of age. At age 16 years, the schedule
reverts to the standard pediatric formulation
3-dose schedule rather than 2 adult doses. |
|
| If you want to
test and vaccinate your patient for hepatitis
B on the same day, does it matter if you test
or vaccinate first? |
|
| Yes. You should
draw the blood first and then administer the
first dose of vaccine, as transient
HBsAg-positivity has been found to occur after
a dose of hepatitis B
vaccine (see next question). |
|
| How long
should a person wait to donate blood or have
an HBsAg blood test after a dose of hepatitis
B vaccine? |
|
| It is advisable
to wait at least 3 weeks. Studies published in
the last several years have found that
transient HBsAg-positivity can be detected for
up to 18 days after
vaccination (up to 52 days among hemodialysis
patients). This does not mean the person is
infected with HBV. However, donating too close
to receipt of hepatitis B
vaccine could cause a person to be permanently
deferred from blood donation if that person
tests transiently HBsAg positive after the
vaccine dose. |
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| Where can I
obtain a copy of the most recent
recommendation of the Advisory Committee on
Immunization Practices (ACIP) for the
prevention of perinatal transmission
of HBV infection? |
|
| The January 2018
recommendations are available at
www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF. |
|
| Should
pregnant women be vaccinated against hepatitis
B during pregnancy? |
|
| Women who are
identified as being at risk for HBV infection
during pregnancy should be vaccinated. They
also should be counseled concerning other
methods to prevent HBV infection. Providers
should administer an age-appropriate 3-dose
series of Twinrix, Engerix-B or Recombivax HB.
Until safety data are available for Heplisav-B
administration during pregnancy, ACIP
recommends providers vaccinate pregnant women
needing HepB vaccination with a vaccine from a
different manufacturer. |
|
| What if
Heplisav-B is inadvertently administered to a
pregnant woman? |
|
| There are
insufficient data available to inform
assessment of Heplisav-B vaccine-associated
risks during pregnancy. The manufacturer,
Dynavax, does not consider pregnancy to be a
contraindication to the use of Heplisav-B.
Dynavax has established a Vaccination in
Pregnancy Registry in order to understand the
effect (if any) of Heplisav-B vaccination
during pregnancy. Women who receive Heplisav-B
within 28 days before pregnancy or at any time
during pregnancy are encouraged to participate
in the registry by calling 1-844-443-7734. |
|
| What is the
schedule for hepatitis B vaccine
administration for infants who weigh less than
2000 grams? |
|
| Decreased
seroconversion rates might occur among preterm
infants with birth weights less than 2,000
grams after administration of hepatitis B
vaccine at birth. However,
by the chronological age of 1 month, all
preterm infants, regardless of initial birth
weight, are likely to respond as adequately as
larger infants. Infants who weigh less than
2,000 grams born to HBsAg-positive women and
women with unknown HBsAg status (if the
mother’s HBsAg status cannot be determined
within 12 hours of birth) must
receive immunoprophylaxis with hepatitis B
vaccine and hepatitis B immune globulin (HBIG)
within 12 hours of birth. The initial vaccine
dose should not be counted toward
completion of the hepatitis B series, and 3
additional doses of hepatitis B vaccine should
be administered, beginning when the infant is
age 1 month. Infants weighing less
than 2,000 grams born to HBsAg-negative
mothers should receive the first dose of the
hepatitis B series at hospital discharge or at
chronological age 1 month (even if
weight is still less than 2,000 grams),
whichever comes first. |
|
| What blood
test should be used to screen a pregnant woman
to prevent perinatal HBV infection? |
|
| Screening should
be done with the hepatitis B surface antigen (HBsAg)
test only. This blood test will tell whether a woman has current HBV infection that can be
transmitted to her infant. Ordering other
blood tests such as total antibody to
hepatitis B core antigen (total anti-HBc)
and/or anti-HBs are not useful when screening
to
prevent perinatal HBV infections and should
not be included in screening pregnant women
for perinatal HBV infection. Total anti-HBc
will be positive in all HBsAg-positive
people and anti-HBs is rarely positive in an
HBsAg-positive person. Women who are found to
be positive should be tested for HBV DNA to
guide the use of maternal
antiviral therapy during pregnancy for the
prevention of perinatal HPV transmission (see MMWR 2018;67 [RR-1]:13). The woman should also
be referred to their
jurisdiction’s Perinatal Hepatitis B
Prevention Program for case management to ensure that their infants receive timely
prophylaxis and follow-up. |
|
| Do women who
have been vaccinated previously against HBV
infection still need to be screened during pregnancy? |
|
| Yes. Women who
have received hepatitis B vaccine should still
be screened for HBsAg early in each pregnancy.
Just because a woman has been vaccinated does
not
mean she is HBsAg negative. Since
postvaccination testing is not performed for
most vaccinated people, she could have been
vaccinated even though she was already
HBsAg positive. |
|
| I've
identified a patient in my obstetrical
practice who is HBsAg positive. Should she be
evaluated for liver disease during her
pregnancy, or should the evaluation wait until
the postpartum period? What should I recommend
for her husband and her children? How urgent
is the time frame? |
|
| The earlier the
evaluation is done, the better. Consultation
with or referral to a liver disease specialist
(such as a hepatologist, gastroenterologist,
or infectious disease
specialist) should be done. The
consulting/referral physician should be aware
of the patient's obstetrical status. In
addition, the patient's sex partner and
children or other
household contacts should be tested for HBV
infection (total anti-HBc and HBsAg) as soon
as possible. If any are susceptible to HBV
infection (total anti-HBc and HBsAg
negative), they should be vaccinated. If any
are HBsAg positive, they should be referred to
or have consultation with a liver disease
specialist. |
|
| If a mother's
HBsAg test result is not available at the time
of birth, how should the infant be managed? |
|
| • |
|
Infants born to women for whom HBsAg
testing results during pregnancy are not
available but other evidence suggestive
of maternal HBV infection exists (for
example 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. |
|
|
|
| • |
|
Women
admitted for delivery without
documentation of HBsAg test results
should have blood drawn and tested as
soon as possible after admission. |
|
|
|
| • |
|
While test
results are pending, all infants with
birth weights of 2,000 grams or more
born to women without documentation of HBsAg test results should receive
the first dose of single-antigen
hepatitis B vaccine (without HBIG)
within 12 hours of birth. Only single
antigen hepatitis B vaccine should be
used for the birth dose. |
|
|
|
| • |
|
If the mother is determined to be HBsAg
positive, her infant should receive HBIG
as soon as possible but no later than
age 7 days, and the vaccine series
should be completed according to a
recommended schedule for infants born to HBsAg-positive mothers. |
|
|
|
| • |
|
If the mother is determined to be HBsAg
negative, the vaccine series should be
completed according to a recommended
schedule for infants born to HBsAg-negative mothers. |
|
|
| For preterm
infants, see the next question. |
|
| Please review
the hepatitis B vaccination recommendations
for preterm infants who weigh less than 2,000 grams (4.4 pounds), as well as for those
premature infants who
weigh more. |
|
Preterm infants
weighing less than 2,000 grams (4.4 pounds) at
birth have a decreased response to hepatitis B vaccine administered before age 1 month. By
age 1
month, medically stable preterm infants,
regardless of initial birth weight or
gestational age, have an immunologic response
to hepatitis B vaccination that is comparable
to
that of full-term infants. For preterm infants
weighing less than 2,000 grams at birth:
|
|
|
|
| • |
|
|
If maternal HBsAg status is positive: |
|
|
|
|
| |
– |
|
Give hepatitis B
immune globulin (HBIG) plus hepatitis
B vaccine within 12 hours of birth.
The birth dose (the initial hepatitis
B vaccine dose) should not be
counted as part of the vaccine series. |
|
|
|
|
| |
– |
|
Give 3 additional
hepatitis B vaccine doses (for a total
of 4 doses) at ages 1, 2 to 3, and 6
months, or hepatitis B-containing
combination vaccine (Pediarix) at
ages 2, 4, and 6 months. The final
dose should not be administered before
24 weeks of age. |
|
|
|
|
| |
– |
|
Test for HBsAg and
anti-HBs at age 9–12 months, or 1–2
months after the final dose of the
vaccine series if completion of the
series is delayed. Testing should
not be performed before age 9 months
(anti-HBs resulting from use of HBIG
might still be positive and therefore
misleading) or within 1 month of the
most recent vaccine
dose (testing for HBsAg sooner than 1
month of a vaccine dose might produce
a transient HBsAg-positivity). |
|
|
|
|
| • |
|
|
If maternal HBsAg status is unknown: |
|
|
|
|
| |
– |
|
If the mother’s HBsAg status cannot be determined
within 12 hours of birth give HBIG
plus hepatitis B vaccine. The birth
dose of vaccine should not be counted
as part of the 3 doses required to
complete the vaccine series. |
|
|
|
|
| |
– |
|
Three additional
doses of vaccine (for a total of 4
doses) should be administered
according to the recommended schedule
on the basis of the mother’s HBsAg
test result. The final dose in the
series should not be administered
before 24 weeks of age. |
|
|
|
|
| • |
|
|
If it
is not possible to determine the
mother’s HBsAg status: |
|
|
|
|
| |
– |
|
The vaccine series should be
completed according to a recommended
schedule for infants born to HBsAg
positive mothers. |
|
|
|
|
| • |
|
|
If the
maternal HBsAg status is negative: |
|
|
|
|
| |
– |
|
If you are certain that
appropriate maternal testing was done
and a copy of the mother's original
laboratory report indicating that she
was HBsAg negative
during this pregnancy is placed on the
infant's chart, delay the first dose
of hepatitis B vaccine until age 1
month or hospital discharge (even if
weight is still less than
2,000 grams), whichever comes first.
Complete the vaccine series per the
recommended schedule. |
|
|
| For preterm
infants weighing 2,000 grams or more at birth,
follow the recommendations for full-term
infants including a dose within 24 hours of
birth. |
|
| What is the
recommended time to do hepatitis B testing for
evidence of success or failure of immunoprophylaxis given at birth to an infant
born to a hepatitis B surface
antigen (HBsAg)-positive mother? |
|
| In 2015, CDC
revised the recommendation for the timing of
hepatitis B serologic testing for infants born
to an HBsAg-positive woman. Postvaccination
testing (HBsAg and
hepatitis B surface antibody [anti-HBs]) is
now recommended 1 to 2 months after completion
of at least three doses of the hepatitis B
vaccine series. For a child on
schedule, this is age 9 to 12 months. Testing
should not be performed before age 9 months,
as hepatitis B immune globulin (HBIG) might
still be present for 6 to 8 months,
nor should testing be performed within 1 month
of the most recent hepatitis B vaccine dose
because a transient false positive HBsAg might
occur. Antibody to hepatitis B
core (anti-HBc) testing of infants or children
is not recommended because passively acquired
maternal anti-HBc might be detected up to age
24 months in children of
HBV-infected mothers. Children who are HBsAg
positive should receive medical evaluation and
ongoing follow-up. For additional information,
see
www.cdc.gov/mmwr/pdf/wk/mm6439.pdf, pages
1118–20. |
|
| How should I
manage an infant of an HBsAg-positive mother
who tests negative for anti-HBs after 3
properly spaced doses of vaccine? |
|
| HBsAg-negative
infants with anti-HBs levels 10 mIU/mL or
higher are protected and need no further
medical management. HBsAg-negative infants
with anti-HBs less than
10 mIU/mL should be revaccinated with a single
dose of hepatitis B vaccine and receive postvaccination serologic testing 1–2 months
later. Infants whose anti-HBs
remains less than 10 mIU/mL following single
dose revaccination should receive 2 additional
doses of hepatitis B 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 less than 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. |
|
| What should I
do if an infant tests negative for anti-HBs
after 2 complete vaccine series? |
|
| Available data do
not suggest a benefit from administering
additional hepatitis B vaccine doses to
infants who have not attained anti-HBs of mIU/mL
or higher following
receipt of two complete hepatitis B vaccine
series. HBsAg-positive infants should be
referred for appropriate follow-up with a
physician who specializes in evaluating
infants with liver disease. |
|
| Is it safe for
an HBsAg-positive mother to breastfeed her
infant? |
|
| Yes. An HBsAg-positive
mother who wishes to breastfeed should be
encouraged to do so, including immediately following delivery. However, the infant should
receive
HBIG and hepatitis B vaccine within 12 hours
of birth. Although HBsAg can be detected in
breast milk, studies done before hepatitis B
vaccine was available showed that
breastfed infants born to HBsAg-positive
mothers did not demonstrate an increased rate
of perinatal or early childhood HBV infection.
More recent studies have shown
that, among infants receiving post-exposure
prophylaxis to prevent perinatal HBV
infection, there is no increased risk of
infection among breastfed infants. |
|
| Can Pediarix
be given at birth? |
|
| No. Pediarix
should not be given before age 6 weeks of age
because it can result in suppression of the
immune response to the acellular pertussis
component. |
|
| If I want to
use Pediarix is it acceptable to give a 4-dose
schedule of hepatitis B vaccine to infants? |
|
| Yes. The use of a
4-dose hepatitis B vaccine schedule is
acceptable when giving the monovalent
hepatitis B vaccine birth dose followed by the
use of Pediarix. The use of
a 4-dose hepatitis B vaccine schedule,
including schedules with a birth dose, has not
increased vaccine reactogenicity and results
in higher final antibody titers that
should correlate with longer duration of
detectable antibody. The federal Vaccines for
Children (VFC) program provides up to four
doses of hepatitis B vaccine for VFC-eligible children. You may still use
monovalent hepatitis B vaccine in a 3-dose
series. |
|
| We give
hepatitis B vaccine to newborns in the
hospital followed by Pediarix at 2, 4, and 6
months of age, so our patients get 4 doses of
hepatitis B vaccine. For some
children, the Pediarix dose #3 is delayed and
given closer to 5 months of age, so the
interval is less than 8 weeks between dose #3
and #4 of the hepatitis B component
of Pediarix. We are receiving conflicting
information about whether their hepatitis B
vaccine dose #4 is a valid final dose because
of the shortened interval between dose
#3 and #4. Our electronic health record says
dose #4 is valid (regardless of the short
interval from dose #3) but the health
department says it is not. Which is correct? |
|
| According to
subject matter experts at CDC, your electronic
health record is correct. The CDC website
states that hepatitis B vaccine dose #4, if
given, must be at 24 weeks of age or later, at
least 16 weeks from dose #1, and at least 8
weeks from dose #2. There is no minimum
interval requirement between dose #4 and the
previous dose. This information is not
published in any current ACIP statement but it
can be found under "Hepatitis B" at
www.cdc.gov/vaccines/programs/cocasa/reports/algorithm-ref.html. |
|
| An infant was
given monovalent hepatitis B vaccine at birth.
Later we gave her monovalent hepatitis B vaccine at age 1 month and age 4 months. Did
we give her the third
dose too early? |
|
| Yes. Poorer
immune response rates are seen in infants who
complete the vaccination series prior to age 6
months. Do not count dose #3, which you gave
at age 4
months. Repeat dose #3 when the infant is at
least 6 months of age (no earlier than age 24
weeks). |
|
| If an infant
got a dose of the adult formulation of
hepatitis B vaccine in error, should the dose
be counted? When should the next dose be
scheduled for this infant? Do we
need to be concerned about a possible adverse
event? |
|
| If an infant
received an adult dose of hepatitis B vaccine
(contains twice the antigen in a dose of the infant/child/adolescent formulation), the dose
can be counted as valid
and does not need to be repeated. Hepatitis B
vaccine is a very safe vaccine and no unusual
adverse events would be expected because of
this administration error. The
next (age appropriate) dose should be given on
the usual schedule. |
|
| The
recommended age for the last dose of hepatitis
B vaccine in an infant is 6 months. What is
the earliest age the last dose can be given to
an infant? |
|
| The minimum age
for the last dose of hepatitis B vaccine is
age 24 weeks (the minimum age is the youngest
age that is acceptable for giving a vaccine
and having it
"count" as a valid dose.) This allows
healthcare providers more flexibility in
administering hepatitis B vaccine should a
parent bring an infant in for a well-baby
check
before the infant reaches a full 6 months of
age. If the third dose is given prior age 24
weeks the dose should not be counted. Poorer
response rates are seen in infants
who complete the vaccination series prior to
age 24 weeks. The third dose should be
repeated when the infant is at least age 24
weeks. |
|
|
|
|
|
| Should all
children age 0 through 18 years be vaccinated
against hepatitis B? |
|
| Yes. CDC
recommends that all children age 0 through 18
years be fully vaccinated with hepatitis B
vaccine. This recommendation is also endorsed
by AAP and AAFP
and is published as part of the annual
Recommended Childhood and Adolescent
Immunization Schedule (www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html).
Vaccination should be initiated for children
and teenagers not previously vaccinated and
vaccination completed for all those whose
vaccine series is incomplete. |
|
| All children and
adolescents younger than age 19 years
(including internationally adopted children)
who were born in Asia, the Pacific Islands,
Africa, or other
intermediate or high-endemic countries or who
have at least one parent who was born in a
high-endemic area should be tested for HBsAg
and should complete the
vaccine series if they were not previously
vaccinated or were incompletely vaccinated. |
|
| Can
adolescents be immunized on a 0-, 2-, 4-month
schedule for hepatitis B? |
|
| Yes. There are
data that show adequate seroprotection using
this schedule in young adults. If this
schedule is used, you should be aware that the
studies were in young
adults and might not translate to older adults
(age 40 years or older). There are other
schedules that offer flexibility in
vaccination as well. View
www.immunize.org/catg.d/p2081.pdf for a review
of different schedules. |
|
| Three years
ago at a middle school, my patient received
the first dose of the hepatitis B vaccine
series. Should I give her the second dose now
or do I need to start over
again with the first dose? |
|
| There is no need
to restart the series. Give the second dose
now and be sure there are at least 8 weeks
between that dose and the third dose.
Increasing the interval
between the first two doses has little effect
on immunogenicity or final antibody
concentration. The third dose confers the
maximum level of seroprotection but acts
primarily as a booster and appears to provide
optimal long-term protection. Longer intervals
between the last two doses result in higher
final antibody levels but might
increase the risk for acquisition of HBV
infection among people who have a delayed
response to vaccination. No differences in immunogenicity have been observed
when one or two doses of hepatitis B vaccine
produced by one manufacturer are followed by
doses from a different manufacturer. |
|
| Describe the
2-dose regimen for hepatitis B vaccine for
certain adolescents. |
|
| For the 2-dose
schedule, the adult dose of Recombivax HB (1.0
mL dose) is administered to adolescents age 11 through 15 years, with the second dose given 4
to 6
months after the first dose. In immunogenicity
studies, antibody concentrations and end seroprotection rates (at least 10 mIU/mL of
anti-HBs) were similar with the 2-dose
schedule and the 3-dose schedule (0.5 mL
dose). As with other hepatitis B vaccination
schedules, if administration of the 2-dose
schedule is interrupted, it is not
necessary to restart the series. Children and
adolescents who have begun vaccination with a
pediatric (0.5 mL) dose of Recombivax HB
should complete the 3-dose
series with this dose. If it is not clear
which dose an adolescent was administered at
the start of a series, the series should be
completed with the 3-dose schedule. |
|
| How should we
complete the series if a 12-year-old starts
the 2-dose Recombivax HB adult formulation
series but fails to receive dose 2 before his
or her 16th birthday? |
|
| The 2-dose
Recombivax HB schedule is only approved for
use in children age 11 through 15 years. A
16-year-old child would need two additional
doses of pediatric
hepatitis B vaccine to complete a 3-dose
series. |
|
| I am confused
about the volume of hepatitis B vaccine dose
to give an adolescent. Is it 0.5 mL or 1.0 mL? |
|
| The dosage
depends on the schedule and manufacturer of
the vaccine that you are using. For children
11 through 15 years of age, the 2-dose Recombivax HB volume is
1.0 mL. Otherwise the 3-dose schedule of
Recombivax HB or Engerix B is 0.5 mL through
age 19 years. . IAC offers a handy resource
with charts detailing the correct
dosages and schedules for monovalent hepatitis
B and hepatitis A vaccines and combination
products that include hepatitis A and
hepatitis B vaccines. Go to
www.immunize.org/catg.d/p2081.pdf. |
|
| I have some
Asian and African children and teens in my
practice who were born abroad. Should I test
them all for hepatitis B, or just make sure
they are all vaccinated? |
|
| All foreign-born
people (including immigrants, refugees, asylum
seekers, and internationally adopted children) born in Asia, the Pacific Islands, Africa, and
other regions
with high or intermediate endemicity of HBV
infection should be tested for HBsAg,
regardless of vaccination status. Initiating
vaccination of immigrant children should not
be delayed while awaiting hepatitis B test
results. All people found to be HBsAg positive
should have ongoing medical management by a
physician knowledgeable about
hepatitis B and its complications. |
|
|
|
|
|
| Which
hepatitis B vaccines can be given to adult
patients? |
|
| Twinrix
(combination HepA-HepB, 3-dose series) and
Heplisav-B (2-dose series) are approved for
adults age 18 years and older. Engerix-B and
Recombivax HB (as a 1.0
mL 3-dose series) are approved for adults age
20 years and older. |
|
| Which adults
should receive hepatitis B vaccine? |
|
| The following
groups are recommended for hepatitis B
vaccination: |
|
| • |
|
Sex partners of HBsAg-positive people |
|
|
|
| • |
|
Sexually active people who are not in
long-term, mutually monogamous
relationships |
|
|
|
| • |
|
People seeking evaluation or treatment
for a sexually-transmitted infection Men
who have sex with men |
|
|
|
| • |
|
Current or
recent injection drug users |
|
|
|
| • |
|
Household
contacts of HBsAg-positive people |
|
|
|
| • |
|
Residents
and staff of facilities for
developmentally disabled people |
|
|
|
| • |
|
Healthcare
and public safety workers with
reasonably anticipated risk for exposure
to blood or blood-contaminated body
fluids |
|
|
|
| • |
|
People with
end-stage renal disease, including
predialysis, hemo-, peritoneal-, and
home-dialysis patients |
|
|
|
| • |
|
International travelers to regions with
intermediate or high levels of HBV
infection; visit
wwwnc.cdc.gov/travel/yellowbook/2018/infectious-diseases-related-to-travel/hepatitis-b for countries with intermediate or high levels of HBV
infection |
|
|
|
| • |
|
People 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 |
|
|
|
| • |
|
People with
hepatitis C virus infection |
|
|
|
| • |
|
People with
HIV infection |
|
|
|
| • |
|
Unvaccinated adults with diabetes
mellitus from 19 through 59 years of age |
|
|
|
| • |
|
Unvaccinated adults with diabetes
mellitus who are age 60 or older at the
clinician's discretion |
|
|
|
| • |
|
Incarcerated persons |
|
|
|
| • |
|
All other
people who wish to be protected from HBV
infection |
|
|
| Acknowledgement
of a specific risk factor is NOT a requirement
for vaccination. The official CDC
recommendations for hepatitis B vaccination of
are available at
www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf. |
| |
| Please provide
details about the ACIP recommendation for the
use of hepatitis B vaccine in adult diabetic patients. |
|
| In 2011, CDC
published ACIP recommendations that hepatitis
B vaccine be given to adults with diabetes.
The vaccine series is recommended for
unvaccinated adults with
diabetes age 59 years and younger. At the
discretion of the treating clinician, the
vaccine may also be administered to
unvaccinated adults with diabetes age 60 years
and older. The recommendations were prompted
by a number of outbreaks of hepatitis B virus
infection in settings that provide assisted
blood glucose monitoring for
people with diabetes. |
|
| Administration of
the hepatitis B vaccine series should be
completed as soon as feasible after diabetes
is diagnosed. No serologic testing or
additional hepatitis B
vaccination is recommended for adults who
received a complete series of hepatitis B
vaccinations at any time in the past. |
|
| Hepatitis B
vaccine may be administered during healthcare
visits scheduled for other purposes, as long
as minimum intervals between doses are
observed. No maximum
interval between doses exists that would make
the hepatitis B vaccination series ineffective
or that would require restarting the series.
You can read the details of this
recommendation and the rationale behind it in
the December 23, 2011 issue of MMWR, available
at
www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a4.htm?s_cid=mm6050a4_w. |
|
| Does the
recommendation to administer hepatitis B
vaccine to diabetics younger than age 60
extend to women with gestational diabetes? |
|
| No. The 2011 CDC
recommendations for hepatitis B vaccination of
people with diabetes pertain to those with
type-1 and type-2 diabetes. They do not apply
to women with
gestational diabetes. It is worth noting that
pregnancy is not a contraindication to
hepatitis B vaccination, and that women with
gestational diabetes are more likely to
develop type-1 or type-2 diabetes later in
life. Diabetic women who become pregnant can
be vaccinated, if indicated. |
|
| At what
anatomic site should hepatitis B vaccine be
administered to adults? What needle size
should be used? |
|
| The deltoid
muscle is recommended for routine
intramuscular (IM) vaccination among adults.
The anterolateral thigh also can be used. The
gluteus muscle should not be
used as a site for administering hepatitis B
vaccine. Please refer to the IAC document
Administering Vaccines to Adults: Dose, Route,
Site, and Needle Size (available at
www.immunize.org/catg.d/p3084.pdf) for
complete information on this issue. |
| |
| Is
post-vaccination testing needed for adults who
receive hepatitis B vaccine? |
|
| Serologic testing
for immunity after vaccination is recommended
only for people whose subsequent clinical management depends on knowledge of their
immune status.
Testing is not necessary after routine
vaccination of adults. |
|
| Post-vaccination
testing is recommended for the following:
healthcare and public safety workers at a
reasonable risk of continued exposure to blood
on the job; immune
compromised people; and sex or needle-sharing
partners of HBsAg-positive people. Testing
should be performed 1 to 2 months after the
last dose of vaccine. |
|
| If a person
has been sexually assaulted, should he/she be
offered HBIG and hepatitis B vaccine? |
|
| Sexually
transmitted infections, including hepatitis B,
can be transmitted by sexual assault. Unless
the victim has a documented history of
completed hepatitis B
vaccination, a series of hepatitis B vaccine
alone (2 or 3 doses depending on brand) should
be administered with the first dose as soon as
possible after the assault.
Administration of hepatitis B immune globulin
is not necessary. |
|
| If a patient
receives hepatitis B vaccine while undergoing
hemodialysis, will the vaccine be effective?
Will the dose need to be repeated? |
|
| Neither the
Advisory Committee on Immunization Practices
(ACIP) nor the manufacturers address the
timing of vaccination and dialysis. Persons
with end-stage renal
disease including predialysis, hemodialysis,
peritoneal dialysis, and home dialysis should
be tested for hepatitis B surface antibody
(anti-HBs) 1–2 months after vaccination, and annually. If the anti-HBs
level is below 10mIU/mL, they should be
revaccinated. |
|
| How often do
hemodialysis patients who have received
hepatitis B vaccination have to be tested for
anti-HBs and HBsAg? |
|
| Recommendations
for immune compromised people, such as
hemodialysis patients, are different than
those for immune-competent people.
Hemodialysis patients who do
not respond to an initial vaccine series
should be revaccinated with two to four
additional doses of hepatitis B vaccine
(depending on the brand).. Hemodialysis patients
are considered immune as long as they have
adequate anti-HBs (at least 10 mIU/mL). For
hemodialysis patients who have responded with
adequate anti-HBs
(postvaccination testing should be done 1 to 2
months after the vaccine series) to hepatitis
B vaccination, no HBsAg testing is needed but
anti-HBs should be done
annually. If anti-HBs declines below 10 mIU/mL,
a booster dose of hepatitis B vaccine should
be given and annual anti-HBs testing should be
continued. Retesting
immediately after the booster dose is not
necessary. |
|
| What is the
maximum number of hepatitis B vaccine doses a
dialysis patient can receive? |
|
| There is no
maximum number of booster doses a dialysis
patient can receive. Serology should be
performed once a year and a booster dose given
if serology is negative
(less than 10 mIU/mL). Serology is not
recommended more frequently than once a year,
so boosters wouldn't be given more than once a
year. |
|
| A physician
ordered a 40-mcg dose of hepatitis B vaccine
for a hemodialysis patient. The clinic does
not stock the Recombivax HB 40-mcg dose
dialysis formulation (Merck) and would like to
give 2 doses of Engerix-B 20-mcg dose (GSK)
for each dose in the series. Is this
acceptable? |
|
| Yes. If given on
the same day as separate injections in
separate sites, two injections of Engerix-B 20
mcg can be counted as the equivalent of one
Recombivax HB 40-mcg dose. According to the
package insert, Engerix-B is licensed for use
in this manner (vaccine package inserts for
all vaccines are available at
www.immunize.org/fda). Note that an all-Engerix-B
or mixed-brand dialysis schedule is a 4-dose
series (doses at 0, 1, 2, and 6 months).
Vaccination using only Recombivax HB dialysis
formulation is a 3-dose schedule (doses at 0,
1, and 6 months). |
|
| Some
nephrologists give a high dose (40 mcg) of
hepatitis B vaccine (2 adult doses of Engerix-B,
or Recombivax HB Dialysis Formulation) to all
patients with renal failure
with glomerular filtration rates (GFRs) of
less than 30 ml/min even if the patient is not
on dialysis. Is this practice advisable? |
|
| A higher dose
hepatitis B vaccine is recommended for
hemodialysis and other immunocompromised
persons, so to the extent these patients are
immunocompromised,
this is within ACIP recommendations (note that "immunocompromised" is not defined in the
recommendations). Regardless, this practice is
appropriate for several
reasons, including that these patients may be
starting hemodialysis soon, and because use of
the higher dose is not harmful. This is
somewhat of a gray area but the
clinician can use his/her clinical judgment. |
|
| Can a dialysis
or pre-dialysis patient receive Heplisav-B
vaccine? |
|
| Yes. |
|
| I would like
more information about Twinrix, the
combination hepatitis A and B vaccine. |
|
| Twinrix
(GlaxoSmithKline) is an inactivated
combination vaccine containing both hepatitis
A virus (HAV) and HBV antigens. The vaccine
contains 720 EL.U. of hepatitis A
antigen (half of the Havrix adult dose) and 20
mcg of hepatitis B antigen (the full Engerix-B
adult dose). In the United States, Twinrix is
licensed for use in people who are
age 18 years or older. It can be administered
to people who are at risk for both hepatitis A
and hepatitis B, such as certain international
travelers, men who have sex with
men, illegal drug users, or to people who want
to be immune to both diseases. |
|
| Primary
immunization consists of 3 doses given
intramuscularly on a 0, 1, and 6 month
schedule. In March 2007, the FDA also approved
a 4-dose schedule for Twinrix. It
consists of 3 doses given within 3 weeks,
followed by a booster dose at 12 months (0, 7
days, 21 to 30 days, and 12 months). The
4-dose schedule could benefit
individuals needing rapid protection from
hepatitis A and hepatitis B, such as people
traveling to high-prevalence areas imminently
and emergency responders, especially
those being deployed to disaster areas
overseas. Twinrix cannot be used for post-exposure prophylaxis. |
|
| I have seen
adults who have had 1 or 2 doses of Twinrix,
but we only carry single-antigen vaccine in
our practice. How should we complete their
vaccination series with
single-antigen vaccines? |
|
| Twinrix is
licensed as a 3-dose series for people age 18
years and older. If Twinrix is not available
or if you choose not to use Twinrix to
complete the Twinrix series, you
should do the following: If 1 dose of Twinrix
was given, complete the series with 2 adult
doses of hepatitis B vaccine and 2 adult doses
of hepatitis A vaccine. If 2 doses of
Twinrix were given, complete the schedule with
1 adult dose of hepatitis A vaccine and 1
adult dose of hepatitis B vaccine. |
|
| Another way to
consider this is as follows: |
|
| • |
|
A dose of Twinrix contains a standard
adult dose of hepatitis B vaccine and a
pediatric dose of hepatitis A vaccine.
So a dose of Twinrix can be substituted
for
any dose of the hepatitis B series but
not for any dose of the hepatitis A
series. |
|
|
|
| • |
|
Any combination of 3 doses of adult
hepatitis B or 3 doses of Twinrix is a
complete series of hepatitis B vaccine |
|
|
|
| • |
|
One dose of
Twinrix and 2 doses of adult hepatitis A
is a complete series of hepatitis A
vaccine |
|
|
|
| • |
|
Two doses
of Twinrix and 1 dose of adult hepatitis
A is a complete series of hepatitis A
vaccine |
|
|
| We're thinking
of using Twinrix and we're wondering whether
we can use it for doses #1 and #3 only and use
single antigen hepatitis B vaccine for dose
#2? |
|
| No. Twinrix
contains 50% less hepatitis A antigen
component than Havrix, GSK's monovalent
hepatitis A vaccine (720 vs. 1440 El. U.) so
the patient would not receive the
recommended dose of hepatitis A vaccine
antigen. For this reason, 3 doses of Twinrix
must comprise the series. |
|
| What are the
minimum intervals for giving the 3-dose series
of Twinrix? |
|
| Minimum intervals
for Twinrix are 4 weeks between dose #1 and
dose #2, and 5 months between dose #2 and dose #3. |
|
|
|
|
|
| Which people
who work in healthcare settings need hepatitis
B vaccine? |
|
| The Occupational
Safety and Health Administration (OSHA)
requires that hepatitis B vaccine be offered
to healthcare personnel (HCP) who have a
reasonable expectation
of being exposed to blood and body fluids on
the job. This requirement does not include
personnel who would not be expected to have
occupational risk (for example,
general office workers). Employers must ensure
that workers who decline hepatitis B
vaccination sign a declination form. For a
fact sheet about this OSHA requirement,
go to:
www.osha.gov/OshDoc/data_BloodborneFacts/bbfact05.pdf. |
|
| At what
anatomic site should hepatitis B vaccine be
administered to adults? What needle size
should be used? |
|
| For adults,
administer hepatitis B vaccine intramuscularly
(IM) in the deltoid muscle. A 22- to 25-gauge,
1–1½ -inch needle should be used. The gluteus
muscle should not
be used as a site for administering hepatitis
B vaccine. For optimal protection, it is
crucial that the vaccine be administered IM,
not subcutaneously. |
|
| Can Heplisav-B
be used for vaccinating healthcare
professionals? |
|
| Yes. Heplisav-B
is approved as a 2-dose schedule for persons
age 18 years and older, including healthcare professionals. The doses should be separated
by at least 4
weeks. |
|
| Can Heplisav-B
be used to complete a vaccination series
started with Engerix-B or Recombivax HB? |
|
| Yes. However,
data are limited on the safety and
immunogenicity effects when Heplisav-B is
interchanged with hepatitis B vaccines from
other manufacturers. When
feasible, the same manufacturer’s vaccines
should be used to complete the series.
However, vaccination should not be deferred
when the manufacturer of the previously
administered vaccine is unknown or when the
vaccine from the same manufacturer is
unavailable. |
|
| The 2-dose
hepatitis B vaccine series only applies when
both doses in the series consist of Heplisav-B.
Series consisting of a combination of 1 dose
of Heplisav-B and a
vaccine from a different manufacturer should
consist of 3 total vaccine doses and should
adhere to the 3-dose schedule minimum
intervals of 4 weeks between dose 1
and 2, 8 weeks between dose 2 and 3, and 16
weeks between dose 1 and 3. Doses administered
at less than the minimum interval should be
repeated. However, a series
containing 2 doses of Heplisav-B administered
at least 4 weeks apart is valid, even if the
patient received a single earlier dose from
another manufacturer. |
|
| I work in
occupational health and have some patients who
are off schedule for their hepatitis B vaccine series. They came back for dose #2 in 4 to 6
months rather than
getting it 1 month later. In this situation, what is the correct timing for dose #3? And
how long must the interval be between doses
before I am required to restart the
series? |
|
| The minimal
intervals for hepatitis B vaccine are at least
4 weeks between doses #1 and #2, at least 8
weeks between doses #2 and #3, and at least 16
weeks between
doses #1 and #3. Since in your cases 16 weeks
or more have elapsed since dose #1, you should
schedule dose #3 to be given 8 weeks after
dose #2. It is not
necessary to restart the series because of an
extended interval between doses, no matter how
long. |
|
| Is it safe for
a healthcare professional to be vaccinated
during pregnancy? |
|
| Yes. Many years
of experience with hepatitis B vaccines
indicate no apparent risk for adverse events
to a developing fetus. Current hepatitis B
vaccines contain
noninfectious hepatitis B surface antigen (HBsAg)
and should pose no risk to the fetus. If not
vaccinated, a pregnant woman may contract an
HBV infection during
pregnancy, which might result in severe
disease for the newborn. Women who breastfeed
their babies and are healthcare professionals
can and should be vaccinated
against hepatitis B if they haven’t been
previously vaccinated. Receipt of the vaccine
is not a reason to discontinue breastfeeding. |
|
| There are no
clinical studies of Heplisav-B in pregnant
women. Available human data on Heplisav-B
administered to pregnant women are
insufficient to assess vaccine-associated risks in pregnancy. Until safety
data are available for Heplisav-B, providers
should continue to vaccinate pregnant women
needing hepatitis B vaccination with
a vaccine from a different manufacturer. |
|
| Which HCP need
serologic testing after receiving a hepatitis
B vaccine series? |
|
| All HCP,
including trainees, who have a high risk of
occupational percutaneous or mucosal exposure
to blood or body fluids (for example, HCP with
direct patient contact,
HCP at risk of needlestick or sharps injury,
laboratory workers who draw, test or handle
blood specimens) should have postvaccination
testing for antibody to hepatitis B
surface antigen (anti-HBs). Postvaccination
testing should be done 1–2 months after the
last dose of vaccine. Postvaccination testing
for persons at low risk for mucosal
or percutaneous exposure to blood or body
fluids (for example, public safety workers and HCP without direct patient contact) likely is
not cost-effective; however, those
who do not undergo postvaccination testing
should be counseled to seek immediate testing
if exposed. |
|
| What should be
done if a healthcare personnel's
postvaccination anti-HBs test is negative
(less than 10 mIU/mL) 1–2 months after the
last dose of vaccine? |
|
| There are two
options for healthcare personnel who test
negative after completing their first
hepatitis B vaccine series. The first option
is to give one dose of hepatitis B vaccine,
then retest for anti-HBs. If the result is
positive, the person should be considered
immune. If negative the person should receive
the remaining doses in the series, and then
retest for anti-HBs. If the result is
positive, the person should be considered
immune. If negative the person should be
tested for HBsAg and total anti-HBc to
determine their HBV infection status. People
who test negative for HBsAg and total anti-HBc
should be considered vaccine non-responders
and susceptible to HBV infection. They should
be counseled about precautions to prevent HBV
infection and the need to obtain hepatitis B
immune globulin (HBIG) prophylaxis for any
known or likely exposure to HBsAg-positive
blood. Those found to be HBsAg negative but
total anti-HBc positive were infected in the
past and require no vaccination or treatment.
If the HBsAg and total anti-HBc tests are
positive, the person should receive
appropriate counseling for preventing
transmission to others as well as referral for
ongoing care to a specialist experienced in
the medical management of chronic HBV
infection. They should not be excluded from
work. |
|
| The second option
is to repeat the 2- or 3-dose series
(depending on vaccine brand) and test for
anti-HBs 1–2 months after the final dose of
the repeat series.
Heplisav-B may be used for revaccination
following an initial hepatitis B vaccine
series that consisted of doses of Heplisav-B
or doses from a different manufacturer.
Heplisav-B may also be used to revaccinate new
healthcare personnel (including the challenge
dose) initially vaccinated with a vaccine from
a different manufacturer in
the distant past who have anti-HBs less than
10 mIU/mL upon hire or matriculation. |
|
| If the test is
still negative after a second vaccine series,
the person should be tested for HBsAg and
total anti-HBc to determine their HBV
infection status. People who
test negative for HBsAg and total anti-HBc
should be considered vaccine non-responders
and susceptible to HBV infection. They should
be counseled about
precautions to prevent HBV infection and the
need to obtain hepatitis B immune globulin (HBIG)
prophylaxis for any known or likely exposure
to HBsAg-positive blood.
Those found to be HBsAg negative but total
anti-HBc positive were infected in the past
and require no vaccination or treatment. If
the HBsAg and total anti-HBc tests are
positive, the person should receive
appropriate counseling for preventing
transmission to others as well as referral for
ongoing care to a specialist experienced in
the
medical management of chronic HBV infection.
They should not be excluded from work. |
|
| The determination
of option 1 and option 2 are based on
epidemiologic considerations and likelihood
that the patient is HBsAg positive, since
there is a delay in option 1
in determining HBsAg status. |
|
| How often
should I test HCP after they've received the
hepatitis B vaccine series to make sure
they're protected? |
|
| For
immunocompetent HCP, periodic testing or
periodic boosting is not needed.
Postvaccination testing (anti-HBs) should be
done 1–2 months after the last dose of the
hepatitis B vaccine series. If adequate anti-HBs
(at least 10 mIU/mL) is present, nothing more
needs to be done. This information should be
made available to the
employee and recorded in the employee's health
record. If postvaccination testing is less
than 10 mIU/mL, the vaccine series should be
repeated and anti-HBs testing
done, 1–2 months after the last dose of the
second series. |
|
| Should a
healthcare professional who performs invasive
procedures and who once had a positive anti-HBs
result be revaccinated if the anti-HBs titer
is rechecked and
is less than 10 mIU/mL? |
|
| No.
Immunocompetent people known to have responded
to hepatitis B vaccination in the past do not
require additional passive or active
immunization. Postvaccination
testing should be done 1–2 months after the
original vaccine series is completed. In this
scenario, the initial postvaccination testing
showed that the healthcare professional was protected. Substantial
evidence suggests that adults who respond to a
hepatitis B vaccine series (anti-HBs of at
least 10 mIU/ mL) are protected from
chronic HBV infection for at least 30 years,
even if there is no detectable anti-HBs
currently. Only immunocompromised people (for
example, dialysis patients, some
HIV-positive people) need to have anti-HBs
testing performed periodically. Booster doses
of vaccine to maintain their protective anti-HBs
concentrations to at least 10
mIU/mL are recommended for dialysis patients
and may be given to some HIV-positive
patients. |
|
| Table 3: Postexposure management of healthcare
personnel after occupational percutaneous and
mucosal exposure to blood and body fluids, by
healthcare personnel HepB vaccination and
response status |
|
|
Healthcare personnel status |
Postexposure testing |
Postexposure prophylaxis |
Postvaccination
serologic
testing† |
Source
patient
(HBsAg) |
HCP
testing
(anti-HBs) |
HBIG* |
Vaccination |
Documented responder§ after
complete series |
No action needed |
Documented
nonresponder¶
after 2 complete series |
Positive/unknown |
Not indicated |
HBIG x2 separated
by 1 month |
— |
No |
|
Negative |
No action needed |
Response
unknown after
complete series |
Positive/unknown |
<10mIU/mL** |
HBIG x1 |
Initiate
revaccination |
Yes |
|
Negative |
<10mIU/mL |
None |
|
Any result |
>10mIU/mL |
No action needed |
Unvaccinated/incompletely
vaccinated or vaccine refusers |
Positive/unknown |
—** |
HBIG x1 |
Complete
vaccination |
Yes |
|
Negative |
— |
None |
Complete
vaccination |
Yes |
|
|
Abbreviations: HCP = health-care
personnel; HBsAg = hepatitis B surface
antigen; anti-HBs = antibody to
hepatitis B surface antigen; HBIG =
hepatitis B
immune globulin. |
|
* |
HBIG should be administered
intramuscularly as soon as possible
after exposure when indicated. The
effectiveness of HBIG when
administered >7 days after percutaneous, mucosal, or nonintact
skin exposures is unknown. HBIG dosage
is 0.06 mL/kg. |
| † |
Should be
performed 1–2 months after the last
dose of the HepB vaccine series (and
6 months after administration of HBIG to avoid detection of passively
administered anti-HBs) using a
quantitative method that allows
detection of the protective
concentration of anti-HBs (>10
mIU/mL). |
| § |
A
responder is defined as a person with
anti-HBs >10 mIU/mL after 1
or more complete series of HepB vaccine. |
|
¶ |
A
nonresponder is defined as a person
with anti-HBs <10 mIU/mL after 2
complete series of HepB vaccine. |
|
** |
HCP who
have anti-HBs <10mIU/mL, or who are
unvaccinated or incompletely
vaccinated, and sustain an exposure to
a source patient who is HBsAg-positive
or
has unknown HBsAg status, should
undergo baseline testing for HBV
infection as soon as possible after
exposure, and follow-up testing
approximately 6 months
later. Initial baseline tests consist
of total anti-HBc; testing at
approximately 6 months consists of
HBsAg and total anti-HBc. |
|
|
Source: This table
from Prevention of Hepatitis B Virus
Infection in the United States:
Recommendations of the Advisory
Committee on Immunization Practices.
MMWR 2018;67(RR-1): 18
www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf |
|
|
| Does CDC
recommend routine pre-exposure anti-HBs
testing of all healthcare personnel who were previously vaccinated? |
|
| In general, no,
but the type of testing (pre-exposure or
post-exposure) depends on the healthcare
worker’s profession and work setting. The risk
for hepatitis B virus
(HBV) infection for vaccinated healthcare
personnel (HCP) can vary widely by setting and
profession. The risk might be low enough in
certain settings that assessment of
hepatitis B surface antibody (anti-HBs) status
and appropriate follow-up can 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 might be applied
on the basis of documented low risk,
implementation, and cost
considerations. Trainees, some occupations
(such as those with frequent exposure to sharp
instruments and blood), and HCP practicing in
certain populations are at
greater risk of exposure to blood or body
fluid exposure from an HBsAg-positive patient.
Vaccinated HCP in these settings/occupations
would benefit from a pre-exposure
approach. |
|
| We have a new
employee with documentation of having received
a series of hepatitis B vaccine as an adolescent. He now tests negative for
hepatitis B surface antibody
(anti-HBs). How should we manage him? |
|
|
ACIP recommends that
healthcare personnel with written
documentation of having received a properly
spaced series of hepatitis B vaccine in the
past (such as in infancy
or adolescence) but who now test negative for
anti-HBs should receive a single "booster"
dose of hepatitis B vaccine and be retested
1–2 months later. Those who test
positive following the "booster" dose are
immune and require no further vaccination or
testing. Those who test negative should
complete a second series of hepatitis B
vaccine on the usual schedule and be tested
again 1–2 months after the last dose. The
"booster" dose counts as the first dose in
this series. Heplisav-B
may be used to revaccinate new healthcare
personnel (including the
challenge dose) initially vaccinated with a
vaccine from a different manufacturer in the
distant past who have anti-HBs less than 10
mIU/mL upon hire or matriculation. For
more information see
www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF,
pages 21-22. |
| |
| If an employee
receives both HBIG and hepatitis B vaccine
after a needlestick from a patient who is
HBsAg positive, how long should one wait to
check the employee’s
response to the vaccine? |
|
| Anti-HBs testing
for HCP who receive both hepatitis B immune
globulin (HBIG) and hepatitis B vaccine can be conducted as soon as 6 months after receipt of
the HBIG. |
|
|
At our facility we
do routine pre-employment anti-HBs testing
regardless of whether the employee has documentation of a hepatitis B vaccination
series and consider
those who are anti-HBs positive to be immune.
Is this the recommended strategy? |
|
| No. HCP with
written documentation of receipt of a
complete, properly spaced series of hepatitis
B vaccine AND a positive anti-HBs can be
considered immune to HBV
and require no further testing or vaccination.
Testing unvaccinated or incompletely
vaccinated HCP (including those without
written documentation of vaccination) is not
necessary and is potentially misleading
because anti-HBs of 10 mIU/mL or higher as a
correlate of vaccine-induced protection has
only been determined for persons who
have completed a hepatitis B vaccination
series. Persons who cannot provide written
documentation of a complete hepatitis B
vaccination series should complete the
series, then be tested for anti-HBs 1 to 2
months after the final dose. |
|
|
Is there a
recommendation for a routine booster dose of
hepatitis B vaccine? |
|
| No. HCP who have
documentation of receiving a complete series
of hepatitis B vaccine and who tested positive
for anti-HBs (defined as anti-HBs of 10 mIU/mL
or
higher) are considered to be immune to
hepatitis B. Immunocompetent persons have
long-term protection against HBV and do not
need further testing or vaccine doses.
Some immunodeficient persons (including those
on hemodialysis) may need periodic booster
doses of hepatitis B vaccine. |
|
|
Does CDC recommend
restarting the hepatitis B vaccine series in
the event the series is interrupted? |
|
| No. The series
should not be restarted. Continue the series
from where you left off. |
|
| Several
physicians in our group have no documentation
showing they received hepatitis B vaccine.
They are relatively sure, however, that they
received the doses many
years ago. What do we do now? |
|
| Because there is
no documentation of vaccination, a vaccination
series should be administered and
postvaccination testing should be performed
1–2 months after the
final dose of vaccine. There is no harm in
receiving extra doses of vaccine. Postvaccination testing results should also be
documented, including the date testing was
performed. All healthcare settings should
develop policies or guidelines to assure valid
hepatitis B immunization. |
|
|
An employee thinks she had 3 doses of
hepatitis B vaccine in the past but has no
documentation of receiving those doses. Before
reading the recommendations to
revaccinate her, we obtained an anti-HBs titer
and the result was greater than 10 mIU/mL.
With this lab result, can't we assume she is
immune? |
|
| No. A positive
anti-HBs indicates that the vaccinated person
is immune at the time the person was tested
but does not assure that the person has
long-term immunity.
Long-term immunity has been demonstrated only
for people attaining an adequate anti-HBs
result of at least 10 mIU/mL after completing
a full vaccination series. The
most direct way to deal with this is to
vaccinate the employee with a series of
hepatitis B vaccine; test for anti-HBs in 1–2 months and document the result in the
employee's health record. An adequate anti-HBs
result from a documented vaccine series would
assure not only seroprotection, but long-term
protection. |
|
|
I'm a nurse who
received the hepatitis B vaccine series more
than 10 years ago and had a positive follow-up titer (at least 10 mIU/mL). At present, my
titer is negative
(less than 10 mIU/ mL). What should I do now? |
|
|
Do nothing. Data show that vaccine-induced
anti-HBs levels might decline over time;
however, immune memory (anamnestic anti-HBs
response) remains intact following
immunization. People with anti-HBs
concentrations that decline to less than 10 mIU/mL are still protected against HBV
infection. For HCP with normal immune status
who
have demonstrated adequate anti-HBs (at least
10 mIU/ mL) following full vaccination,
booster doses of vaccine or periodic anti-HBs
testing are not recommended. |
|
|
If an employee
does not respond to hepatitis B vaccination
(employee has had two full series of hepatitis
B vaccine), does s/he need to be removed from
activities that
expose her/him to bloodborne pathogens? Does the employer have a responsibility in this
area beyond providing vaccine? |
|
|
No. There are no regulations that require
removal from job situations where exposure to
bloodborne pathogens could occur; this is an
individual policy decision within the
organization. OSHA regulations require that
employees in jobs where there is a reasonable
risk of exposure to blood be offered hepatitis
B vaccine. In addition, the
regulation states that adequate personal
protective equipment be provided and that
standard precautions be followed. Check your
state OSHA regulations regarding
additional requirements. If there are no state
OSHA regulations, federal OSHA regulations
should be followed. Adequate documentation
should be placed in the employee
record regarding non-response to vaccination.
HCP who do not respond to vaccination should
be tested for HBsAg and total anti-HBc to
determine if they have chronic
HBV infection. If the HBsAg and total anti-HBc
tests are positive, HCP should receive
appropriate counseling for preventing
transmission to others as well as referral for
ongoing care to a specialist experienced in
the medical management of chronic HBV
infection. Persons who are HBsAg-positive and
who perform exposure-prone
procedures should seek counsel from a review
panel comprised of experts with a balanced
perspective (for example, infectious disease
specialists and their personal
physician[s]) regarding the procedures that
they can perform safely. They should not be
excluded from work. People who test negative
for HBsAg should be considered
susceptible to HBV infection and should be
counseled about precautions to prevent HBV
infection and the need to obtain HBIG
prophylaxis for any known or likely
exposure to HBsAg-positive blood (see Table
3). |
|
|
Can a person with
chronic HBV infection work in a healthcare
setting? |
|
| Yes. HCP should
not be discriminated against because of their
hepatitis B status. All HCP should practice
standard precautions, which are designed to
prevent HBV
transmission, both from patients to HCP and
from HCP to patient. There is, however, one
caveat concerning HBV-infected HCP. Those who
have HBV levels 1000 IU/mL
or 5000 genomic equivalents/mL or higher
should not perform exposure-prone procedures
(for example, gynecologic, cardiothoracic
surgery) unless they have sought
counsel from an expert review panel and been
advised under what circumstances, if any, they
may continue to perform these procedures. For
more information on this
issue, see "Updated CDC Recommendations for
the Management of Hepatitis B Virus–Infected
Health-Care Providers and Students," MMWR,
2012; 61(RR03):1-12. This
document is available at
www.cdc.gov/mmwr/pdf/rr/rr6103.pdf. |
|
|
|
|
|
| Is hepatitis B
vaccine safe? |
|
| Yes. Hepatitis B
vaccines have been demonstrated to be safe
when administered to infants, children,
adolescents, and adults. Since 1982, more than
an estimated 70
million adolescents and adults and more than
50 million infants and children in the United
States have received at least one dose of
hepatitis B vaccine; more than a billion
doses of hepatitis B vaccine have been given
worldwide. Vaccination causes a sore arm
occasionally, but serious reactions are very
rare. |
|
| Is it safe to
give hepatitis B vaccine to a pregnant woman? |
|
| Yes. Many years
of experience with hepatitis B vaccines
indicates no apparent risk for adverse events
to a developing fetus. Current vaccines
contain noninfectious
HBsAg and pose no risk to the fetus. If the
mother is being vaccinated because she is at
risk for HBV infection (for example, a
healthcare worker, a person with a sexually
transmitted disease, an injection drug user, a
person with multiple sex partners, or a person
with diabetes who is 19 through 59 years of
age), vaccination should be
initiated as soon as her risk factor is
identified during the pregnancy. HBV infection
affecting a pregnant woman might result in
severe disease for the mother and chronic
infection for the newborn. |
|
| There are no
clinical studies of Heplisav-B in pregnant
women. Available human data on Heplisav-B
administered to pregnant women are
insufficient to assess vaccine-associated risks in pregnancy. Until safety
data are available for Heplisav-B, providers
should continue to vaccinate pregnant women
needing hepatitis B vaccination with
a vaccine from a different manufacturer. |
|
| Does a birth
dose of vaccine increase the risk of elevated
temperature and subsequent microbiologic evaluations? |
|
| No.
Administration of hepatitis B vaccine soon
after birth has not been associated with an
increased rate of elevated temperatures or
subsequent evaluations for possible
sepsis in the first 21 days of life. |
|
|
|
|
|
| Who should not
receive hepatitis B vaccine? |
|
| A serious
allergic reaction to a prior dose of hepatitis
B vaccine or a vaccine component is a
contraindication to further doses of hepatitis
B vaccine. The recombinant
vaccines that are licensed for use in the
United States are synthesized yeast cells into
which a plasmid containing the gene for HBsAg
has been inserted. Purified HBsAg
is obtained by lysing the yeast cells and
separating HBsAg from the yeast components by
biochemical and biophysical techniques. People
with a severe allergic to yeast
should not be vaccinated with vaccines
produced in yeast cells. |
|
| As with other
vaccines, vaccination of people with moderate
or severe acute illness, with or without
fever, should be deferred until the illness
improves. Vaccination is not
contraindicated in people with a history of
multiple sclerosis, Guillain-Barrè syndrome,
or autoimmune diseases such as systemic lupus
erythematosis or rheumatoid
arthritis. |
|
|
|
|
|
| How should
hepatitis B vaccine be stored? |
|
| All hepatitis
B-containing vaccine should be stored at
refrigerator temperature at 2°C to 8°C (35°F
to 46°F). The vaccines must not be frozen. Any
vaccine exposed to
freezing temperature should not be used. Do
not use these or any other vaccines after the
expiration date shown on the packaging. Any
vaccine administered after its
expiration date should be repeated. |
| |
ACIP Recommendations
Vaccine Information Statements 
